An Unexpected Retirement

 In an unexpected turn of events at the end of last month, my manager announced that she was retiring.

It was not a completely unexpected outcome:  I had no idea how old she is (and it is never polite to ask a lady) but it turns out that this was the year that it could all work for her.  Also, for the past 5 years she has been commuting from her home in the next state over and staying in New Home 2.0 four days a week before heading back for three days a week.  She will be retiring to her family farm, where she will be working on her art and her rather large (and expanding garden).

As you can imagine, this has upset the apple cart a bit.

One of the immediate questions that came up from my coworkers and even my direct reports was "Will you apply for the job?"  I thought about it for something like five minutes; knowing what I know about the position and the state of the work world, I do not have the particular elements of the industry experience nor the long experience at working at a large company that those who make such decisions put into the job description.

Besides, not one person in the hiring chain suggested I throw my hat into the ring, which tells me volumes.  That, and the fact that having done that role once before (which ended in Hammerfall 2.0), I was not terribly eager to throw myself into that fire again.  I have no need to build a career or empire at this point: I am just trying to make it to retirement.

What it does mean, though, is for interim - and who knows how long that will last - I will be acting in her stead.

That is not as daunting as a task at it may seem at first blush: internally I know everyone in the department and the transfer of responsibilities in terms of reporting will be minimal.  Yes, my schedule in terms of one on one meetings is about to double (I will likely be spending 8 hours a week talking to people), but most everyone is pretty self-sufficient at this point.  They do not need me to tell them what to do (in general); often they just want an ear to listen to them with challenges.

The daunting part will be that - at least for the intervening period of time - I will be the one everyone wants a decision from.

I have been in this position before and know exactly what it is like: e-mails and chats throughout the day, people grabbing you in hallways, and of course the ever present growth of meetings. It becomes almost impossible to do your actual "work".

The other side of this, of course, is what happens when that person is hired.

I have already had some such discussion with my team.  I have reminded them that, given everything that we are doing, no-one has any interest in disrupting ongoing operations; if anything, we have become more valuable than before because leadership (that amorphous term that refers to a series of groups of people above our heads) wants things to continue to move forward.  But I also know, from painful experience, that it is always uncomfortable and always engenders change.

And then, of course, there is my own adjustment.

There will be that initial stage where the incoming person knows nothing and is just meeting people and going to meetings to gain context, followed by the gradual assumption of responsibilities and then the setting of a course, perhaps a different course, than what we have been on.  And then the inevitable reorganization that happens and what will become the "New Normal".

My estimate? This will take the rest of the year to settle out, assuming that person arrives within one or two months.

I am super happy for my manager.  She deserves this retirement and I hope it is a good one for her.  But I am really sad for the rest of us.

Maybe even sadder for me.  Because she had a wealth of experience and was a great manager.  No matter who comes in, it will be a very different feel.  I worry a bit for my own future - not so much in another Hammerfall scenario, but rather in the scenario of either being pigeonholed or having nowhere to go.

I just have to keep reminding myself head down like a bison in a snowstorm.  This, too, shall pass.

Moving On Up

 You may recall approximately two months ago I had applied for a managerial position at my current place of employ:  same department, some of the same duties, same people.  The process took a bit longer than I think anyone had anticipated, partially complicated by the fact that I had hauled off and gone out of the country for two weeks.

I received a job offer last week.

The offer is for a manager level position; I would be primarily responsible for a certain subsection of the activities that we do - although still doing a lot of things; we are too small a department for true specialization.  I would be "managing" five of my current peers - I say "managing" as they all know far more than I do of the operations and the history behind them. Beyond the potential increase in bonus and stock option structure, a somewhat nice thing is that due to my "years of managerial experience" (or less delicately put, I am old) they were able to increase the amount of increase between levels.  As a result, combined with my annual raise it is almost a 23% increase in the little over a year since I started here.

While I am pretty pleased with the outcome - from one of the interviewers, a friend (I actually knew and had worked with every single interviewer I had), the other candidates were credible so it was not just a slam dunk - it did strike me as a little odd.  After all, most people do not go from individual contributor to managerial level in a year. I checked with my "new" reports about how they felt about everything, mostly because I was once assigned to a former coworker when they got promoted rather hurriedly and it was not a great experience (in fact, I ended up leaving that position about six months later).  No-one seemed particularly concerned about that aspect, hopefully because they know me now well enough that a change in level is not of any concern (I remain, as I tell them, exactly as you know me now:  What You See Is What You Get).

I have to confess I feel the tiniest bit of satisfaction at this news - not just because of the promotion, but because I feel that it validates my strategy of taking the position originally:  rather than apply for a managerial position that I might or might not make the initial intake scan because of my background and lack of a scientific degree in a science field, I applied for an individual contributor role,  hoping that I could demonstrate my value and eventually things would change.

In that sense, my strategy worked out better than I had hoped.

My official new role starts next Wednesday (beginning of the pay period).  Nothing really changes in practice, other than the fact that I will have even more e-mails and more meetings (the sign of "rising in the modern corporate world).  But I do enjoy my job and my coworkers.

And for the first time in a very long time, I neither have to drive to a new place nor learn new systems (or move to new locations!) to start a new role.  All in all, not a bad way to "start" a new position.

Linking Out 2.0

 Last week I closed down my Linked Out account.

I did this once before as in turns out in January of 2017; my logic at that time was combination of leaving my professional information out there to be contacted by old organizations, its function as a  sales channel, a lack of real benefit, and leaving myself "out there".   Times change of course - being laid off will do that to you - and so last year I dusted off the old account and fired it up.

A little over a year later, I am re-powering it down.  Likely for good.

Some of my reasoning has not changed.  

Linked Out (now a wholly own subsidiary of Microsoft) is, on the one hand, the premier career linking and information site. Its competitors are either industry specific or not in the same league.   But for that size, it is surprisingly bland.  Part of that is due to a conscious movement to "Not Make Linked Out The Book Of Face" (e.g., limit or completely exclude typical social media fare). To that extent, it does not generate controversy.  But what it also brings along with it is a form of content uniformity that both (in my mind) supports a particular world view as well as likely subverts any meaningful discussion.

That is fine of course; I do not go to a career site inherently to discuss something like economics or my view of the decline of society or methods of making yogurt at home.  But neither do I go to a site to find that there is simply one view, and one view only, of the world.

A second factor - as before - simply that the site does not do anything for me.

Yes, it is useful to follow up with contacts from previous companies - but likely those contacts only ever reach out in the event that 1) They are looking for a job for themselves or another contact at another company; or 2) They are trying to leverage you for information on a current employer.  In terms of actual conversation, it is at a minimum at best.

Additionally, in terms of actual results for the reason I renewed - job searching - its results were minimal at best.

Of the 86 jobs I applied for during Hammerfall 3.0, the bulk of them were through the Linked Out Portal.  Some went directly to the employer's in-box, others sent me to the employer's website to complete the application there (e.g., I really could have found it on my own).  Of the four job listings that went farther than a rejection, only one came from a contact there.  One was through personal contacts and two were through directly applying at the employer's website (including the one I took).

In other words, I could have done just as well by searching websites and applying directly (as, it turns out, I did).

A third factor is simply the lack of different it makes in my life.  The postings are, for the most part, people getting jobs, leaving jobs, or talking about aspect of their companies (mostly about how great they are) with some "Why employers are failing us" sorts of lists and memes.  99% of these have no impact on my life and since I gained employment, I have done quite well without those sorts of updates.

The final reasons are personal.

The first personal reason is as before:  simply put, it is one more way to pull my personal information back into myself.  Yes, that posting is out there on the Wayback machine if someone wants to go to the trouble, but in principle on such things, it is probably better to make it as inconvenient as possible.

The second personal reason is that this is an extension of my policy in Responding To The World At Large II in that Microsoft (arguably) does not really support the sorts of things I believe in or my world view.  Yes, my puny single account going away (and a free one at that) will not impact their bottom line - except.  Except that that is one less marketing dollar they can get for me, on less "Out-mail" someone has to buy to contact me.  Not much, I grant you, but a philosophical victory all the same.

The third personal reason is simply that I intend this to be the end of the job line.

I do not know how long I have left to work (or how long left to live, if you get right down to it), but certainly my desire is that this current job in New Home 2.0 is the last formal "job" I hold.  In that sense, my canceling of Linked Out is the equivalent for me of burning the boats.  There is only, ever forward on this track.

Will I miss Linked Out?  The open secret is no - and I would bet that most people, if they were honest, would not.  Outside of the rarified atmosphere that permeates anyone that needs regular social media updates (and be clear:  Linked Out is a form of social media like every other), most people at best need it like that tool you need every six months to fix a particular problem:  nice to have, but not something that is front and center in your life.

On A Lesser Salary

 One of the realizations that has come with the initiation of the new job is that I have entered a period of time of declining income, not a rising one.

That probably seems like a very First World problem - after all (I hear you say), you spent last year looking for jobs not once not twice.  And you yourself admitted that you were likely overpaid at your last position for longer than you should have been.

Fair points and well taken.  I am simply looking at it from the trajectory of the typical career and my experience of the last 25 years.

It is fair to say over my time in the biopharmaceutical/medical device industry, I have done well.  I have done very well, the sort of well that could not have been replicated except in the nascent IT industry of its day (which I was more or less contemporaneous with).  From my entry into the industry, hard work and application allowed me to see my salary rise over time.  Sometimes it a cost of living increase, sometimes it was a promotion, but it was always ever up.  Even when I fell out from The Firm (which was a financial setback of epic proportions; in retrospect I wonder what would have happened if I had simply stayed put) or Hammerfall, I was able to effectively re-enter the industry at my previous salary (or close enough).

That changed with Hammerfall 2.0 and Hammerfall 3.0.  

Hammerfall 2.0 and the resulting salary drop was a not a surprise - I was overpaid for reasons that I will never understand (but, to be fair, never questioned).  Hammerfall 3.0 and New Home 2.0 continued that trend. 

Does money matter?  Not in terms of my ego (just as title does not matter at this point), but in terms of practical living absolutely.  All here know the relentless grind of inflation; a drop in salary helps nothing there.

For fun (because when is future planning not fun?), I ran a simple analysis of my current salary and added in the potential of a cost of living increase (3%, if you are curious).  It takes me four years to get to what I made prior to Hammerfall 2.0.  If I extend it to 10 years from now, it is still okay (but probably effectively the same as today given inflation). 

But I never touch what I made prior to 2020.

One of the assumptions that many young people have is that their salary and their careers will only ever go up.  We older ones know; careers are just often lateral moves and sometimes reverses not just of position, but of finance.  For those that know this, they can adjust and move on.

For those that do not and find their sum total in what they are called and what they earn, it can be a difficult adjustment indeed.

Anatomy Of A Modern Layoff: The Specialization Paradox

 "Specialization is for insects.  A human being should be able to change a diaper, plan an invasion, butcher a hog, conn a ship, design a building, write a sonnet, balance accounts, build a wall, set a bone, comfort the dying, take orders, give orders, cooperate, act alone, solve equations, analyze a new problem, pitch manure, program a computer, cook a tasty meal, fight efficiently, die gallantly."
        - Robert A. Heinlein (through the character Lazarus Long)

Specialization is part of the requirements of a modern civilization.  At some point, things become too complex for the generalist to make and maintain the things that make our modern civilization go - not just complex things like computers and autos, but what many consider simple things like construction and plumbing.

Using yesterday's post as a leaping off point, I wanted to consider the idea of a specialization paradox in modern employment.  To use this example, I will start with myself.

As most readers know, the bulk of my post college working life has been in a single industry,  biopharmaceuticals/medical devices (88% if you were wondering, less 2% for layoff periods and 10% for non-related careers).   That has given me both a general set of skills as well as a very specific set of knowledge and skills for a very specific industry - not just practices and experience, but regulatory knowledge and industry knowledge.

One question that comes up from time to time is "Can you find work in other industries that have similar titles of work?"  The answer is more often than not, no.  I referenced this last week as well, but in point of fact "Quality Assurance" is a field that encompasses everything from airplane manufacture to cheese manufacture, from computer programs to automobiles.  In some cases there may be some similarities and some similar documentation - for example, the International Standards Organization (ISO) Standards - but like almost anything, there are significant differences in application (the same is true of project management as well).

Additionally, many companies are not that open to the idea of a "generalist" - for example, every food producer I have looked at is very specific in that they want previous food industry experience to consider you.  As in "Do not bother to apply if you do not have it".  Which makes sense, as it makes sense for almost any industry:  after all, they want to bring in individuals that have the knowledge base and just need the specific product and corporate base.  And given the current market, they do not need to lower their standards.

Could one start all over at one of these companies?  I suppose the answer is a qualified yes, given two points.  The first is that the company really needs a "Fill in the Blank" Level I.  The second is that the individual being hired needs to be able to live on the entry level wage. 

The other reality is that, from the corporate side, they do not need to hire the unqualified or generalists.  When I started in the industry, things like Biomedical Engineering was in its infancy.  Now, the ability to get a job in this industry in many functions (though not all) presume a Bachelor's degree or above, mostly in a scientific field - the path I took into the industry simply no longer exists.  Thus be default, more and more people are entering in this industry - and many industries - already heavily slanted towards "I am doing this for a career".

Can someone up and change careers?  Of course it is possible and people have done it.  But it requires a number of factors both personal and professional, including the ability to start over completely and - depending on one's age - acknowledgment of the fact that one may not rise to anything but a lower rung.  It also requires the ability to weather the financial loss of income.

All of that said, let us now apply it to many of the folks currently being laid off.

Like me (and most), likely they have spent a certain amount of time and education and knowledge specializing in a field. Now, they find themselves out in the wilderness of the unemployed, competing not only against others but in some cases their own previous friends and coworkers.  There are some jobs - there always are - but these (right now, at least) are contracting more than they are expanding.  

What to do?  Scrap 10 to 30 years of education and experience to start over?  Try to find a job in a lesser role in hopes that it turns into something more (knowing, of course, that entry level opportunity-hungry and less expensive employees are coming up after you)?  Hold out hope that there will be a turnaround in your industry?  Start your own business and hope it makes it?  Just continue to look for work until benefits cease and you have to take something?

This is paradox of specialization:  having created a civilization that essentially requires it, we are required at some level to invest our lives in some field in order to work in it.  And yet that specialization harms us when we are in a position where there are more people in that specialty than jobs - because many other industries also have that level of specialization which are required and they, in turn, have people that have specialized to that.  Perhaps a bit contrary to Heinlein's point, specialization is not quite a thing to scoffed at for insects only; we benefit greatly from it.

The third option, of course, is the one I have chosen on Produce (A)Isle:  the semi-skilled laborer.  Even less previous knowledge and education required, but must be willing to 1) Take a reduced salary; and 2) Be willing to step down in the social order of things.  

Even when I was working Produce (A)Isle and my day job, the reduced salary was not an issue as it was additional funds (less so now, of course - and it alone would not support us, even at full time).  And the social order of things has never really bothered me - as I have told all that I have interviewed with, I am at a point where I no longer care about what my position is or how I am viewed; I am not building a career or starting an empire or trying to rise through ranks.   I just want a job that pays the bills, lets me follow my hobbies, and allows me to deepen the knowledge of my inidustry.

But I wonder, especially for those that have never done such work or have spent the last years doing their dream jobs which they have specialized in.  Will they be able to pivot if necessary?  Can they flip the switch and re-specialize? Will they be willing to do less if that is what there is?

I do not have answers of course, and as I am in the latter part of my career am probably not the best example for them.   But it strikes me that we are either on the brink of simple destruction or a creative destruction and renaissance.  How that plays out will be fascinating to watch.

Anatomy of A Modern Layoff: Social Media Edition

 It occurs to me that as I am spending more time than most around looking for work and layoffs, it might be useful to provide a perspective on what a "modern" layoff looks like.  I say this because the perspective has changed.

Once upon a time, layoffs were conducted essentially invisibly.  Perhaps it was something that was known nationally, like a major manufacturer, or perhaps unrecognized except to the local community.  It was known to the family and possibly friends, although this might not be as true as one might think:  even as an adult, I remember having to have a conversation with Uisdean Ruadh letting him know that it was okay to talk about the fact that he had been laid off as it happened to lots of people anymore and was not some kind of "black mark" on your permanent record.  One went about and found a replacement job quietly, combing the want ads of papers or looking out for the signs in windows.

As with everything else, it is not like that today.

Oftentimes it will start with a post on social media by the individual, running something like thus:

"The news is true:  I and XX number of my fellow employees were laid off at Company Y today.  Hard to believe it was already z years.  We did so much together in our time there.  We are (surprised/shocked/in disbelief/not surprised) at this.  Such an incredibly talented group of of people.

That said, I am now #Opentowork.

I have n number of years doing a, b, c and am looking forward to providing a future employer with the same level of (service/innovation/excellent work) that I have to my former employer.  

Looking forward to doing great things with someone else."

This - or a version of this, there is essentially a template now - will be posted on LinkedOut as well.  If one desires, one can put a small "#Opentowork" sidebar in one's photo.

The whole thing interests me on an intellectual level (beyond the personal level, of course) because of the public nature of it - in fact, people almost seem to transition from the last minute at the office to posting online. 

Full disclosure:  When I got laid off in Hammerfall 3.0, I did make a post on The Book of Face - not so much to advertise for work as to inform friends and family of the fact (sometimes these things are rather public; better to allay fears now), advertise for good thoughts and prayers, and re-emphasize that we are fine (essentially what I do here as well).  But I did not do the same on LinkedOut, other than indicate (invisibly to the public) that I was looking for a job.  Perhaps I am simply old school, but the point of this is to find a job, not to make a fuss about it.

In our social media world, this seems to be less of a concern - as with other things, the idea that we put everything in excruciating detail of our lives out for the public to see is present here as well.  

I will be fair that for most of the posts I have seen, denigrating one's former employer is hardly ever done.  That makes sense to me of course:  in essentially advertising one's current status, the last thing a future employer is likely to want to see is one tearing down one's former employer - makes the new employer a bit concerned, not doubt.

How does this end?  I am not sure.  As layoffs continue to accelerate and become more public, I do not wonder that this sorts of personal informational update posts will take on a more Spartan and informational nature:  "Laid off today.  25 years experience in x.  Looking for work in the following industries".  Part of that, I suspect, is simply that people will want to simply stand out in a world of general updates.

The other part, of course, is that at some point continued economic pressure means the push will be to secure employment - not necessarily the employment one "wants" but the employment one needs.

Biopharmaceuticals And Medical Devices: A General Overview II (Drugs)

 In Biopharmaceuticals And Medical Devices: A General Overview I, we looked at the underlying basis of all drugs (pharmaceuticals and biologics) and discussed the development of a compound from initial discovery to the completion of Non-Clinical Laboratory Studies and the decision to move forward.  Today, we are picking up with starting clinical manufacture and clinical trials.

There are really three streams here:  clinical trials, clinical manufacture, and regulatory submission.  I am going to defer the regulatory submissions to later in the week as there are some small similarities with the Medical Device process.

Clinical Manufacture

Clinical manufacture is the manufacture of a drug to support a clinical trial.

Typically, clinical manufacture is divided into two phases, the manufacture of the actual compound (called an "Active Pharmaceutical Ingredient" for pharmaceuticals and "Drug Substance" for biologics) and the manufacture of the finished form of the product such as pills, capsules, filled liquid vials, lyophilized solutions, etc. called the  Drug Product.

The work done in the investigatory and pilot plant manufacture will be scaled up in volume to support the clinical trial, for example from a 5 L fermentation to a 50 L fermentation to a 600 L or 1000 L fermentation.  Process Development will work to find the ideal conditions for manufacture and all required buffers, medias, or reagents.  Process Sciences will develop criteria to evaluate the product - called "specifications" - which will allow testing during manufacture ("in process"), after manufacturing ("release"), or over time to evaluate how long the drug product remains "good" ("stability").  They will also identify tests to support these criteria.  

At some point, the developed process and associated tests and specifications will be transferred to the Operations Group.  Here, a variety of operations - Manufacturing, Quality Assurance, Purchasing and Supply Chain, Quality Control - will purchase and test incoming raw materials, write and approve manufacturing records for every part of the process, write and approve testing documents for all identified tests, and create final release documents so the product can be evaluated and made available for clinical trials.  The facility to be used will have to demonstrate that the meet the required regulatory and physical conditions for manufacture including temperature and humidity control, air particulate control, and micro-organism control. The equipment to be used - both manufacturing and testing - will need to be qualified to verify it is installed correctly, works correctly, and works for the process. Likewise, all quality control testing will have to be qualified to verify that the tests are repeatable, give verified data, and can be performed by multiple personnel potentially in different labs.

One note: development of the manufacturing process and manufacturing may be conducted in-house at the company or outsourced to a third party vendor, called a Contract Manufacturing Organization ("CMO") or Contract Development and Manufacturing Organization ("CDMO").  There are trade-offs between time and money; for many small companies they have no choice but to use a CMO as building out and qualifying an in-house manufacturing plant can be expensive and time consuming.

In the background of all of this (and by regulation), every company has a Quality System, which is the System put in place to guarantee that all product manufacture is conducted in such a fashion to ensure the identity, strength, purity, quality, and safety of the product.  This includes instructions on how to do things ("Standard Operating Procedures", or SOPs) for every aspect of the organization that is regulated, how to evaluate issues and failures (Deviations or Nonconformities), how to make improvements (Corrective Actions and Preventive Actions), how to manufacture and test the product (as above), and how to release the product. For all of these documents, evidence of training must exist.

Assuming all of this is in place, manufacturing will start.

Manufacturing will often start with a "non-GMP" batch, sometimes called an Engineering Batch.  This lot cannot be used for clinical trials but can demonstrate that the process can generate the Drug API/Drug Substance/Finished Product at sufficient scale and with sufficient quality.  If successful, manufacturing will move into GMP/ Clinical Trial material mode.

As trials advance (see below) the manufacturing and testing will progress as well.  As more is known about the product, tighter controls will need to be put in place.  Sometimes a problem only reveals itself over time through stability, which may mean going back to development.  Better and more extensive testing will develop.  And the process size will scale up as well to support commercial manufacture; for biological products, up to 20,000 L fermentation vessels exist for manufacturing

Clinical Trials

Clinical trials for Drugs in the U.S. (and largely, the world) are divided into three phases.  Each phase gathers information about the product and its impact on patients, but each phase also has a primary goal:

Phase 1 (also Phase I or P1) evaluates safety, or "Is the product (at a high level) safe?"

Phase 2 (also Phase II or P2) evaluates efficacy, or "Does the product do what we think it should do?"

Phase 3 (also Phase III or P3) evaluates dosing range, or "What is the best dosing level that maximizes benefit and minimizes patient impact?"

The primary concern of all Clinical Trials is ultimately the safety of the patient (this largely derives from World War II, where live in human testing was conducted (Read up on the testing in concentration camps and Unit 731 of the Imperial Japanese Army.  It is horrifying.).  To this end, 21 CFR Part include items specifically around the involvement of patients, physicians, and companies (Parts 50, 54, 56, and 312) as well as the International Committee on Harmonization document E6.  In short, patients must be fully informed and able to withdraw at any time.  Physicians cannot have a significant financial interest in a company for which they are testing a Drug Product.  An Independent Review Board ("IRB") must review all documents associated with a trial and make sure it protects patients, is ethical, and is scientifically justified.

To use an unapproved Drug Product ("investigational drug" in the regulated world) in humans, the company ("Sponsor")  is governed by 21 CFR Part 21 Part 312, Investigational New Drug Application.  In short, one has to provide an Investigational New Drug Application (called an "IND") and have it approved by the US FDA prior to starting the trial.

The IND will provide a description of the product, a history of its development, proposed release and stability criteria,  a summary of the Non-Clinical Laboratory Studies (GLP and non-GLP Compliant), and the proposed Clinical documentation.

Leading up to the IND, the company is developing documentation for the Clinical Trial:  an Investigator's Brochure, to explain the product and the trial to physicians and site staff; a Pharmacy Manual to explain how to prepare the product for patient use; an Informed Consent which explains to the patients about the trial and their potential participation and potential risks; a Clinical Protocol, which explains how the trial is to be conducted, what is to be tested, how patients should be included or excluded based on criteria, and the endpoints of the trial; the Statistical Analysis Plan created, which ensures that the study has the minimum of number of patients to power the study statistically and can deliver definitive data; and the Clinical Trial Documentation, which is used to record all data for the trial (often this is now electronic).  All of the documents are reviewed and approved internally by the company, by the IRB and by the FDA upon submission of the IND.  Any of these parties can require changes to any of these documents, which then need re-approval.

At the same time, the company is also identifying sites which would be willing to conduct the clinical trial. This is a lot more work that it may sound like:  there are always more trials than sites and some sites are more desirable than others.  For each site a contract must be written and signed, a budget prepared and approved (sites are paid to conduct these trials), all the documentation above provided, and supporting supplies provided.

Conduct of the Clinical Trial

Assuming all the product is manufactured and approved, all clinical documentation is approved, clinical sites have been identified and initiated, and the IND has been approved (or revised and approved as needed), the clinical trial can start.

Clinical trials escalate in size and scope as they progress.  A Phase 1 trial can have as few as 20 patients and 3 sites; a Phase 3 trial can have as many as 7,000 patients and multiple sites in multiple countries.  Study progress is based on the ability to enroll subjects - and have them complete the program.  Not all patients can be evaluated.  Patients may be rare, depending on the inclusion criteria.  If an Unexpected Adverse Event or Serious Adverse Event happens - something that causes transient, partial, or permanent damage to the patient including death or disablement - the trial may be stopped temporarily or permanently. 

During the trial, company personnel from the Clinical, Medical Affairs, Regulatory Affairs, and Quality Assurance departments work intensely with the sites.  Clinical Trial Monitors or Clinical Trial Associates contact and/or visit sites frequently to check up on the trial and audit documentation and product.  Medical Affairs personnel assess data and answer questions.  Quality Assurance evaluates potential complaints.  Regulatory Affairs reports any Unexpected or Serious Adverse events to the Regulatory Authorities.  Meanwhile as needed, Manufacturing, Purchasing and Supply Chain, Quality Assurance, Facilities, and Quality Control continue to do their jobs to ensure that Drug is available for the study.

Periodically the trial may be evaluated by statisticians to evaluate the data.  There may be a reason to cut the trial short, either because the data is overwhelmingly indicative of the endpoints or the data demonstrates no progress to the endpoints or is even risky.

Thoughts

As you can hopefully see, there is a lot to "testing the product in a person".

Perhaps unsurprisingly, a main factor is cost - not just of the all the work to make the product and get to the clinical trial, but for the clinical trial itself.  I would hesitate to provide a number for even the most basic of clinical trials, but it is easily in the millions of dollars for a Phase 1 trial - and goes up from there.  

And the cost escalates of course.  Phase 2 trials are more expensive than Phase 1 trials, and Phase 3 trials are even more expensive.  And the cost of scaling up manufacturing and testing increases as well.  

The funding of a company really determines its future at these stage. Most companies have enough funding to complete a Phase 1 clinical trial.  The hope is that the data from that Phase 1 trial will support getting additional funding to continue to Phase 2, then Phase 3.  Obviously, a failed Phase 1 trial pretty much can spell doom for an early stage company and many layoffs occur after a "setback" in the Phase 1 trial.

But it can happen at any step.  Phase 2 trials fail as well, and Phase 3 also.  The cost of those failures is significantly increased in terms of money as well as prestige:  a Phase 3 trial means that at some point, some signal was missed in an earlier trial.  This can reflect poorly on the company's executive management and scientific basis.  Established companies with commercial products can survive this; most non-commercial companies cannot.

And we have still not arrived at the ability to sell a single Drug Product and thus generate any revenue for all of the work done to date.

Tomorrow we will turn our attention to Medical Devices and how they reach this same point of pre-submission.

Biopharmaceuticals And Medical Devices: A General Overview I (Drugs)

FOTB (Friend Of This Blog) Leigh from Five Acres and A Dream made the following comment in my update on Week 4 of Hammerfall 3.0:

"Being in the "retired category of folks myself, I feel really out of the loop in understanding such things, but I have to ask why your particular industry seems to be struggling so.  I mean (probably naively), it's in the medical/health care arena, and people always need these things, so it would seem that the demand for the supply should keep the industry thriving.  I'm guessing the answer is extremely complicated but it's one of those things that just doesn't make sense."

It is a fair question - after all, the Pharmaceutical/Biotechnology/Medical Device Industry impacts almost everyone at some point (if you have used an aspirin or a bandage, you have participated).  Hopefully I can shed some illumination.  

For reference how I know about this: I have over 25 years of experience in the industry in Manufacturing, Quality, and Project Management had have worked for almost every type of manufacturer (pharmaceutical, biologic, medical device) for products being developed, products in the approval process, and approved products.

I will start with Biopharmaceuticals and then move to Medical Devices.

(Note 1:  This is a very generalized description of the process.  There is a lot of underlying details and processes which, while important, would rapidly spiral of control.)

(Note 2:  For the purposes of this discussion,  I will just use "Drugs" to describe both pharmaceuticals and biologics.)

The most important thing to remember about all of this is that all Drugs in the U.S., be they small molecule (e.g., generated by chemical or "pharmaceutical") or large molecule (generated by biologic process,  or "biologics") are regulated by U.S. Law.  The history of how we got here is long, but suffice it to say in our day, the US Food and Drug Administration (FDA) is responsible for ensuring that all drugs are safe and effective.  The origins of this authority are found in the 1938 Food, Drug, and Cosmetic Act (FD&C Act) and have been expanded ever since.  The regulations for drug manufacture (and much of biologic manufacture) is found in the Code of Federal Regulations (CFR), Title 21, Parts 210 and 211 (and part 600 for certain biologics).  

Unlike International Standards like the International Standards Organization (ISO) or the International Committee on Harmonization (ICH), these regulations must be complied with (as opposed to the standards, which must be conformed to) - unless the standards have been taken into U.S. law as a consensus standard (which many have been).  Every nation has their own set of regulations that must be complied with:  for example, if you are going to sell products in the U.S. and Europe, you have two sets of regulations to comply with.  Often these are similar, but sometimes there are differences which can be significant and must be planned for.

Thus everything that has to do with drug development and drug manufacture is regulated.  The closer one gets to submission for approval, the more regulated things become.

The second most important thing to remember is that all Drugs have side effects.  Every single one.  Drugs are thus evaluated on a risk/benefit basis: does the benefit of a drug outweigh the risks and impacts?  Everyone is familiar with the impact of chemotherapy on the individual in terms of visible impacts (loss of fast growing cells like hair follicles) and not quite as visible impacts (loss of appetite, nausea, loss of ability to taste, lowered immune resistance).  In this case, the benefit (fighting cancer) outweighs the impacts and risk (all the physical impacts above and, frankly, dying of an infection due to a lowered immune system).

Drugs all start in a lab.  There is a promising compound or a significant unmet need that drives scientists to look for a solution.  After going through hundreds or even thousands of compounds (via lab screening or computer models), they discover one which (maybe) has an effect on a condition on a medical condition.  Most likely it is perceived as a novel impact, as "me-too" drugs have a higher bar to succeed in the market.  Also, multiple labs may be working on the same condition, so the development becomes a race to be first (for a novel compound) or a race to be more effective (where a drug already exists for a condition).

Once a compound is identified, it has to be tested to verify that it has the effect that scientists think it has.  This is done in several ways - in silico ("in silicon", or using computer models). in vitro (literally "in glass", or under controlled laboratory conditions with the target cells or molecules), in vivo ("in the living" or using live animals (only, at this point - live humans come later),  Generally the progression is from in silico (where available) to in vitro (cell studies) to in vivo (animal testing).  At the same time as the product is being tested, a basic manufacturing process is being designed:  what conditions, what medias and buffers, what manufacturing steps have to be in place to make "the compound".  Not only does the compound need to have an effect, it needs to be able to be manufactured.

Assuming we now have the compound, it has to be put through some level of paces to make sure it is worth moving forward with.  Typically the product will be characterized (to learn all they can about it) and placed against a set of criteria that will define if the product meets the anticipated needs of the criteria identified (sometimes called "Target Product Profile") and can be manufactured.  If it meets both criteria, it will move forward (if not, of course, it gets discontinued).   At the point (or slightly before), small scale lots (pilot lots) will be manufactured and animal testing starts.

No-one I know of in the industry is fond of animal testing (also called "Non-Clinical Laboratory" Testing), but the other option at this stage is "testing straight in people", which for some pretty strong historical reasons is a bad idea.  A species which simulates the human system or condition to be tested is selected (typically starting with mice and ending with non-human primates, but other species animals may be used based on the nature of the disease or condition being evaluated) and the product tested per a protocol.  Often, necropsy is performed and the data reviewed, looking for 1) Efficacy and 2) Impact to to the physical systems.  Pharmacokinetics (the movement of the drug through the body) and Pharmacodynamics (the biological, physiological, and molecular impact of the drug on the body) are measured.  For this testing, the controlling regulation is 21 CFR Part 58, Good Laboratory Practice for Non-Clinical Studies (also referred to as GLP).  These test can be either non-GLP (for general data generation or proof of concept) or GLP (required to move the product into clinical trials).

All of this does not come cheaply, of course.  Scientists require labs, and labs required equipment and reagents and personnel to run them.  Small manufacturing lots need a pilot plant internal to the company or an external contract manufacturing organization (CMO) to manufacture them.  And Non-Clinical laboratory studies need to be conducted:  as of last year, a small mouse study ran $250,000 at a minimum and a non-human primate study $1.3 million.  Generally there is more than one mouse study and a minimum of one major animal study (such as non-human primates).   Add to that that scheduling for these studies is anywhere from 4 months (for mice) to 9 months or more (for non-human primates).

If helpful for reference, products that I have worked on to get to this point - not including internal overhead for personnel, lab space, equipment, etc. - have cost between $2 million and $4 million.  Just to get to the point of possibly using it in an early clinical trial.

Assuming all of this data indicates 1) There is some benefit; and 2) The benefit outweighs the impact, and 3)  The compound can probably be manufactured,  the compound will likely be moved to scaled manufacture and clinical trials of the compounds in humans (which we will review tomorrow).

Career Advice

 During the course of the Hammerfall 3.0, a young woman with whom I had worked a bit reached out to me in the aftermath.  Would I be interested in having coffee to talk about careers?  We had a bit of back and forth on the scheduling, but the meeting finally happened this past week.

I interacted with her most directly just before everything fell apart. She was memorable to me at one point because she made the comment about this being her first "grown-up" job.  That comment made me laugh (out loud, as it turned out) as it was exactly the sort of thing I would say.

Since I had a lead up to the meeting, I had some time to think about the nature of the conversation.  Beyond the sorts of questions that I thought I could predict, what could I actually bring to the conversation?  I tried to think back on similar times in my own life when I, in turn, had asked questions of others.

Oddly enough, I do not remember getting any specific advice in those sessions.  So then I took a different tack with myself - given where I was now, what do I wish I would have known or asked back in the day?  This turned out to be an easier question to answer.

For our coffee based meeting (all good career meetings should be coffee based), we exchanged information on what we knew, each from our side of the situation, about our layoff events and who else we knew that was laid off.  We talked about careers a bit - what it was like to work in Quality, how to "break into" Quality (as if any sensible person wants to break into a form of prison), and the industry in general.  I did throw in a couple of question as well that I hoped would generate some thought longer term down the road:

1)  "What do you really want to do?" - In this case, it was her first job in the industry.  But was it really what she desired to do, or was it convenient and was it something she could see herself doing for a longer period of time.  It is one thing to try something and realize that it is not for you; it is another thing to stick with something and then 20+ years in realize that you are trapped without a way out.  Now was as good a time as any to really consider this question as the opportunity to redirect would be much easier than if one is long invested in a career and skill set that needs to be completely changed.

2)  "Are you thinking outside the box?" - It turns out there are a lot of things that involve what we do, but in ways that people do not generally think of.  For example, if one's interest is in process engineering, it is not just chemical and oil companies (or biotechnology) that uses these skills.  Distilleries, breweries, wineries - they all use the same basic principles.  Sometimes looking at our skills in an industry blinds us to looking at the skill set we bring and the industries we could apply it to.

Ultimately, of course, I can do very little to influence the course of another's job search or life journey.  What I can do - what any of us can do, especially those of who are a bit more "senior" - is to gently ask the sorts of things that, 20 or 30 years ago, we might have benefitted in hearing and thinking about.

Because, at least in my case, if I can save one person from being trapped in a career they see no way out of, I will have done a good thing.

Highways And Offramps

 This week has been a gamut of emotions.

I have tried to keep myself busy.  Raked leaves at the base of the driveway, until the Cowboy and said "Let me show you how to use your dad's tractor so you can load the leaves in the bucket".  So I got to drive the tractor, which was fun.

Spent most of yesterday playing "landlord" down at The Cabin, cleaning gutters and blowing pine needles and leaves off of roofs and using the tractor (again) to haul them away.  Saw my Aunt and Uncle and the sister and The Outdoorsman.

I have also tried to set everything up for restarting the job search.  Filed my unemployment claim (Due to the way the law works, I cannot actually file for a financial claim until 27 December, over two weeks after my layoff).  Cleared out and recreated my spreadsheets to start tracking applications again.  Revised my resume to add my most recent job (a small revision, to be sure).  

I have had some developments.  One ex-colleague has offered to talk to me about consulting.  Another friend has reached out with a position in New Home at the company I came from two companies ago, when we first moved to New Home.  Having a potential opportunity is good; the thought of having to commute that much again makes me sad.

To be somewhat honest, the "looking at the bright side" has faded a bit.

I know that this is a gamut experience and a long haul sort of thing. And I keep reminding myself that God is clearly in control here and I am (in that sense) just along for the ride.  And yet...

And yet I feel, perhaps, trapped.  If either of these works, it is an immediate answer to a question that needs answering and at least for one of the options, would pretty clearly demonstrate that God wants us to stay in New Home for at least some time longer (after all, why else would He keep arranging things to keep us here).  But either of them feels like "more of the same" - what it really feels like is the last slow exhaling of anything of anything but what is reality now.

Of course, none of that is certain - it is Day Five, I remind myself.  But I remain shocked at how quickly I feel deflated, that somehow the walls are already closing in. I have barely started a new search and already I feel like there is only one highway, a long one in the same direction that I have already been going instead of the offramp I was thinking this was.

It is too early to tell, of course.  But keeping myself out of a spiraling circle of despair or depression may require more attention than I anticipated.

Hammerfall 3.0

 "...We interrupt our normally scheduled travel post this morning for an urgent update from our valiant fighters on the front lines.  We take you to our intrepid reporter located deep within the trenches of No-Man’s Land...."

The whole thing started out - as these things do - with an oddly placed question from one of my direct reports.

"Do you know what happened to X?"  was the question. "I cannot send an e-mail to her anymore".

I went and looked at our org chart program.  The name was no longer listed.

"Probably let go" I responded.  My company has an odd way of silently "disappearing" people that the KGB would admire for its efficiency.

"That is sad" was the response.  "She was helping me with a number of things."

I then got an email from my boss.  "Would you be able to move our meeting on Monday to Tuesday?  I will be in town."

I did not specifically remember her being in town - budget constraints and all - but said that was not a problem, although I would not be able to meet with her in person as I was at The Ranch, which we had clearly communicated about for a month.  No worries she said; the invite was moved.

I mentioned both of the incidents to my work confidante, the Dog Whisperer.  "Did you about Y?" was her response. "She got laid off this morning after coming back from maternity leave."  She then asked "Your meeting is not scheduled in the conference room of The Black Hole, right?  Because that is where they lay people off".

I then checked the conference room schedule.  Sure enough, I was not in The Black Hole - but the conference room that I was in was also scheduled at the same time with the HR department.  For two and a half hours.

Clever readers will start to do the math.

By the end of the day my meeting had moved again to even earlier (0815) and was now overlapping with the Dog Whisperer's meeting in the same room at at 0845 (my meeting was for an hour).  We triangulated with other work acquaintances, who also suddenly now had early morning meetings of 15 minutes in duration.  Also, it was noted that both the conference room I was in and The Black Hole were occupied by HR, one for 4.5 hours, one for 2.5 hours.  Using our higher math superpowers, that was a total of up to 28 people.  

By 1700 I was 95% certain to the point I called The Ravishing Mrs. TB and had documented a list of everything I was working on.  Because, you know, you can never be too sure.

The good news, I suppose, is that my psychic powers (at least in this aspect) were 100% right.

The actual event was better than I expected (final count was 20).  Officially I am "furloughed", which means they (in theory) have every hope of rehiring me in 6 to 9 months.  I have two choices: I can take a two week severance pay and 1 month of benefits, or retain my furloughed status and have my severance pay applied to my benefits package (which would be 4 months, so ending in April).  No vacation payout of course, as we had an "endless vacation" policy with no actual earned PTO.

Obviously being laid off twice in one year is not an ideal situation (especially from a single industry), but things could have been a lot worse - for example, four months of benefits means one less thing to worry about.  I have my job at Produce (A)Isle that is ongoing and I can always see about a few more hours there, whereas last time I had nothing.  And apparently furlough status does not interfere with unemployment (which, as soon as I get my formal paperwork, I will get on resubmitting a claim with the learnings from earlier this year).

But - at least for me, if I look really hard at this - Someone's fingerprints are all over this.

I am at The Ranch this week, which means I am around my social group.  I had previously set up a dinner on Monday night with The Director, which was exactly the dinner I needed to have with the person I needed to have it with (Best opening in the door line ever in response to "How are you doing?":  "I am getting laid off tomorrow.  Huzzah!").  And my usual Friday call with Rainbow on writing got moved to Monday because of timing - again, just when I needed it to happen.  And who better to blow off steam with and complain than with Uisdean Ruadh, who is literally 100 yards away from where I write?  Plus seeing my sister and The Outdoorsman.  And my in-laws. And my mother, of course.  

And being here at The Ranch.

There is more to be thankful for - yes, we just put down a lot of money for a roof down payment and a brake job, but that had to be done anyway, and we did it without having to agonize over the decision.  My training is Japan this coming January is 100% paid for thanks to the job at Produce (A)Isle by 31 December, the last paycheck for the year.  Na Clann  will be home for Christmas. And we all have our health.

Long time readers know that I have struggling these last three or four months with a sense of purpose and direction - to the point that Sunday night I prayed that God would clearly give me some sense of what direction I should go.  Apparently the response needed to be clear enough that even I could not miss it:

Me: "I wonder what I should do?"

Circumstances:  "God enters the chat..."

Is it a rather unfortunate occurrence that it happened right before Christmas? Well sure, the timing is not great - except my Product (A)Isle schedule is already baked and suddenly I have a lot more time to actually partake in and enjoy the season and my family and all the blessings that we truly do have, that this change in fortune cannot take away.

Your prayers and kind thoughts are both solicited and appreciated; something will obviously have to be done and decided upon because we are not in anything like a position of being able to retire.  But to be clear, while an inconvenience this is not the end of the world for us.  It is just a sort of opportunity to recalibrate and figure out what "that next step" is, to quote Resident Optimist Ed.

Besides, there is never a time like the present to completely decide to reimagine your life, by choice or by circumstance.

On New Jobs And Schedules: An Update

 How is the new job and schedule going?

Frankly, harder than I had anticipated.

The new job itself is going well.  Nice people, good project, engaging work. Lots and lots of engaging work - in short, lots of forward momentum in my area got cut short when the department essentially all left, so there is a lot to catch up on.  The bright side is that the days really fly now instead of dragging.  I look up once and it is noon; I look up again and it is time to go home.  Plus, they provide snacks.

The contrast between working at a company that has forward momentum and a company that is effectively dead is stunning - you forget that such a difference exists until you change companies.  Suddenly everyone is excited - maybe not always for the best of reasons - and there is a flurry of activity.  One almost forget what anticipation of a success was actually like.

That said, it has added another hour or so to my day due to the commute.  The commute itself is not an issue as it is fairly benign and gets me a chance to catch up on listening to things, but it is time that I used to have.

The balancing act is really with working my other job.

On any given week now I work two to four days there.  During the week, my shifts can be Tuesday, Thursday and Friday from 1700 to 2000.  To hit this time, I have to leave my first job at 1630, drive 15 minutes, change in the car, and work.  I will get home around 2020 or so in the evening, followed by a quick bite, some kind of relaxing, and then to bed.  On Saturdays, my shift will be 1330 to 2000.

What that has all played itself out to is that - in its most busy form - I will be either at work or at Iaijutsu six nights a week.  It always tends to compress my sleep time, which tends to compress my free time.

This has not been an ideal outcome, but it is the outcome that is.

Is the second job helping? It is.  But oddly enough (I say oddly - this was a predictable outcome) there is no desire on my part to spend any of it.  Part of it is what would I spend it on when I am already a bit short on free time; the other is that given the state of things, I am wise not to spend it at all.  

I keep working to parse down what I am doing and spend my time more wisely.  I will say that having this much less free time (ah, those times earlier this year when I thought I was "bored") focuses the mind wonderfully. It also has the very real outcome that less can be done.

The thing I keep reminding myself is that this adjustment would have to made sooner or later.  And I am still miles ahead of people who are under significant financial stress and having to do this sort of thing.

It is hard, in a way, to "go back", pick up, and move forward. I am only a month or so into this adjustment and am trying to be patient with myself as I continue to struggle to adjust.  Better to harden myself now for the future though, rather than to pretend somehow I cannot do this sort of thing.  

Flexibility and the ability to work hard at whatever one does is not a guarantor of success - but it does at least move one in the right direction.

On Starting A New Job

The first week of the new job is done, more or less.

Starting a new job is almost always a predictable experience, at least in my field.  It will start with introductory training - here is the facility, here is where the coffee is, here is your desk - followed by a series of meetings on specific training items:  safety, IT, the basics of the Quality system.   Likely a meeting with one's team, if one has one.

And then, one is left in front of the computer.

It is an odd sort of thing.  You are almost an isolated incident in the midst of people that are already engaged and going about their business.  You start grinding through the documents (usually Standard Operating Procedures in my industry) with some hope of getting some understanding of the systems (which can be hard, as you have no understanding of the use of them and the linkages between them) as a babble of conversation goes on around you about subjects which you know nothing about (but soon will shortly). 

There is always some awkwardness if you are an introvert as I am.  You never really quite fit in at lunch facilities if they have one.  You look for a coffee cup (if you have not brought your own) without looking like you are looking for a coffee cup.  People introduce themselves to you - or do not; people and companies are different.

The second day seems like the first, except there tend to be more meetings and less reading.  E-mails start to flow in with more regularity as well.  You begin to apply good practices to organizing your e-mails because you learned - last company - that if you do not start organizing from the beginning, they will become a mess in relatively short order.

By the third day you are likely an old hand:  you confidently stride in the door in the morning and fire up the computer, getting the cup of morning coffee in your mug (as you have finally brought one), greeting people by name or by smile.  The e-mails are reviewed as the file folders for them grow.  Likely you have completed the bulk of your initial reading and are making notes on what needs to change and what your goals over the next few months and years will be.

The specifics change, of course - for example at my new employer, they actually have snacks and a drink refrigerator, so I am learning what there is available (and pacing myself - I will eat my own weight in snacks, given the opportunity - but in general it is the same, as it has been for the last 25 years. 

Is it somewhat awkward?  For me, it always is.  But at least it is awkward in a way that I have learned to live with and manage.  I have now done this enough that I know we will move through to actually productivity quickly enough.

That, and for the first time ever, this could potentially be my last "new" gig.  And that brings a certain joy to the situation all of its own.

Hammerfall 2.0: Of Produce

 This week I completed my initial on the job training for my part-time produce job.

It has been seven years since I have had to start a new position and something like twenty-five years since I have started a job not in this industry, so the process has been an interesting one.  As you may recall, I had an initial round of on-line training over the last three weeks or so, which involved about 8 hours of videos, a combination of company history, safety practices, introduction to the department, and a small dose of personnel related training.

After that, it was out to the floor to work closing.

Produce, as it turns out (perhaps not to my surprise) is not inherently a terribly difficult job   It consists of facing produce and moving it up in the shelf/bin, replenishing stock that has been sold, culling produce that has damage, putting new stock out from the cold box, cleaning, and customer service.  In that sense, even an unfortunately over-educated individual like myself can thrive in such an environment.

Transferring and culling is to my mind the most difficult, as I had to make decisions on what stays and what goes. I am not at all good at interpreting when fruits and vegetables are "past their prime" beyond demonstrated issues such as mold and soft spots, but I started to learn (for example, apparently if avocadoes feel like a bag of wet sand, they are past their prime and apples which feel more waxy are nearing the same point).  If one has shopped for produce in the past, it is helpful:  knowing at home where the issues are with fruit and vegetables, I can more easily identified them at the store.  I know what the start of mold in strawberry packages looks like, or soft spots in tomatoes or the beginnings of wilt and slime in leafy greens.  In other words, do unto customers at the store as you do for yourself at home.

Customer interactions - something I tend to dread as an introvert - were really not that difficult or challenging.  Most people have questions about out of stocks or where to find something or occasionally the price of something, questions that are pretty easily answered and I am sure I will get better at.

Out of Stocks: There seems to be no rhyme or reason.  In the two days I worked, we were out of red onions (1 day) and grapes (3 days).  Why?  Who knows.  If they are not on the morning truck, we do not have them.  Not sure if it is a localized store issue or wider, but that would be an interesting metric to track to see if seasonality or other issues are factors.

For the first time in I cannot remember, how long,  I had a mandated 30 minute lunch (unpaid) and 15 minute break (paid).  30 minutes, as it turns out, is more than enough time to eat, check things on your phone, and be a bit bored.

The works was not terribly strenuous, as the boxes and bins themselves are not too heavy, nor did I find myself particularly sore the day after.  It has been a considerable amount of time since I have been on my feet for that long, something which is probably good for me (and one reason I contemplated such a job in the first place).

How did I find it overall?  Honestly, not that bad.  Other than the concern in my mind about missing something that was going bad or not moving older fruits and vegetables up front (grading avocadoes may be the death of me), it was just the right amount of busy: there is a schedule and work to be done, but it is not highly mentally demanding and it keeps the hands busy and my biggest decision to date was whether to cull something or not, not thing like "How much have we spent on a $20 million project" or "Do I need to reject this material that cost us $1 million to make?".  The lack of stress, at least there, was palpable.

My intent is to keep this job regardless of the outcome of my current job search and, even if I find an industry job, to keep it as long as I can.  It makes for a good palate cleanser.  I like getting 15% off house brands (and I have already used that to good effect).  It has me actually being active.  And frankly, even if the money is not a great deal, I honestly feel more proud of the two checks I have gotten so far than my earnings for years (which is surprising to me as it is obviously much less).

Martin Luther argued for the dignity of work, whether lay or clerical.  Sometimes there is nothing like a manual sort of job to remind one that all work has dignity based not on the importance or salary, but simply on the fact that it is productive labor.

A Sort Of Hammerfalll and Looking Back

 Longer time readers of this blog may recall that in 2020 I went through what I called "A Sort of Hammerfall", the result of which was a change in my career path from my then-role in Quality Assurance to my current (and now perhaps, passing) role in Project Management.  The core of that change was the review from that year, in which it was noted I had "troubling flaws".

That was the single worst review I have ever received in my life for any job. And it has haunted me to this day.

A large part of the haunting - and frankly, my reluctance to reconsider Quality positions - is the fact that at some point I would have to explain the complete change in careers and why (likely) I would be seeking a lesser position.  Or more pithily put, why I essentially got dismissed from a senior management position.

This all suddenly has relevance as the initial screen I had this past week has turned into a hiring manager and panel interview next week. I have done my research and the individuals I will be speaking with appear to be educated and intelligent people (and thanks again for the continued prayers and well wishes.  If I could continue to ask for them, I would be ever so grateful.).  So I presume some form of the question will come up.

The reality is that I have never really dealt with that review.

If you recall, my response at the time was to simply agree with my then boss, as much due to my dislike of confrontation as well as the knowledge that arguing a fait accompli is 93% of the time a complete waste of effort in that the decision is usually already made and the chances of changing it are zero.  One thing that did ensure, however, is that I never had to actually respond to the observations.

Last Sunday during my visit to a different church, the point of the sermon was that as Christ did not look back after the resurrection, so we too are not to look back.  Admittedly the Resurrection of the Son of God and my review from three years ago are on slightly different planes of importance, but the point remains the same: as any number of memes with heroic pictures will tell you, do not look back as you are not headed that way.

Over two years after that review, I created a document with just the observations - my failings - written down. This was the first time I could bring myself to even look at the document, as it is not just looking at the document: it is recalling all the feelings surrounding it and going into the meeting assuming I was to be fired and then reading that, at least in the eyes of the reviewer, I had completely failed in my job.  But I kept it instead of just dumping it - for all of everything it represented and it how it made me feel, there are parts that are true that I needed to address.

This week I finally responded to the observations.

The observations were not long or particularly well thought out. In some cases they were literally "This was not true".  In others, they were "notifications were sent" or "resources were not made available as noted".  In some, they were "agreed, and this is how my current role has addressed that".

It was not great writing, and certainly not the quality of material I try to purvey here.  Even in this exercise, it is still hard to read those words.  But at least I got something down on paper.

And, almost instantly, felt better.

This exercise does not fix a lot of things.  It does not change the events or the last three years.  I will still have to answer questions, walking an honest line between what happened and my interpretation of what happened.  And if even I disagree with a lot of what was written, I need - for my own intellectual honesty if nothing else - to be able to check each and every one of those off the "flaws I need to correct" list.

But confronting something, even after all these years, is a great place to start moving forward.

Hammerfall 2.0: Hard Stops And New Parachutes

 It is still too early to make an accurate assessment (perhaps) on my job search, although it does feel like a few trends are beginning to manifest themselves.  One is that my career in Project Management may have been a short one - yes, it is too early to formally gain an assessment in that, but those roles seem to be the ones I have most quickly heard refusals from (or nothing at all).  As the bulk of my applications to date have been for this sort of role, the apparent lack of silence is interesting.  Or as a friend noted, Project Manager is a pretty generic title and likely a lot of people are out there.  

---

This week the thought struck me as I was in a dead zone of "looking for positions but nothing coming up" that in a relatively short period of time (really July as due to sundry reasons we are out a great deal of June), my days are going to look completely different.  Yes, I will in some fashion be filling them with part time work, but that still leaves a lot of day.

And so the though occurred to me:  what I did something radically different?  What if I changed my life?

Realistically, continuing to look for a job will consume a very small portion of my day.  So what if, instead of doubling down on skills (real or imagined) for this career, I looked to fill them with other things?

What would that look like?  I am not really sure as of this writing.  Some readily at hand things that come to mind:  a deep reorganization of the items I own (long overdue), more Iai practice, areas of study I have not not had the time to engage in as I might like, writing (of course)...the list is not infinite, but there are a lot of possibilities (that frankly, given what I have here in terms of resources, would cost me nothing but time).

The meaningful question to me is "Why am I not considering this more actively?"

It is funny how normalcy bias is viewed when seen in others versus seen in ourselves.  In others, it becomes clearly visible; in ourselves, perhaps we often engage in it without even trying.

The end of May is looming large in a great many ways:  end of job, end of employer related health coverage (that search is on), end of a known income amount, end of gym membership (cut due to costs; I have a smaller facility that is much cheaper but without near the equipment). 

But literally right after that in June, we have an overseas vacation coming (which was already paid for and thus, non-refundable) that I am very much looking forward to as well as the first opportunity to train with the head of my sword school in three years.

It is as if a hard - very hard - and bright line is being drawn.

I have, for the last 27 years, either been in or instinctively returned to my industry as it was known and safe.  But I wonder:  what if this perhaps not just another break in the history, but rather the end of it?  That rather than lingering in something I should move on from, God has graciously taken the liberty of  helping me exit the plane at 10,000 feet?

Intellectually I understand the concept.  Emotionally, I find myself shying away from it intensely and reaching for a parachute that is not there instead of looking to my Instructor for a different one.

What Is The Plan?

"So, Toirdhealbheach Beucail, what is your plan?"

This question has come up (perhaps unsurprisingly) more than once.  And I am sure everyone means it in the best of ways - not "Get off your duff and plan" but "Do you know what is next?"

The simple answer, of course is no.  But simple answers do not make for actual decision.  

"What you need is a plan" - Sun Tzu, "Inspirational Quotes of The Spring- Autumn Period" (Probably)

There are two sides to it.

The first, of course, is my formerly current employer.  I am going through and declining all meetings that I do not have any responsibility in and am not 100% responsible for (except those meetings that function as overall updates; I remain curious up to the end how this whole thing will play out).  I am organizing my e-mail for convenient archiving purposes (to be fair, it is already largely organized - I am just putting the final touches on it).  And I am blocking out any and all time that is not directly related to any meetings I must be at (no, you do not get to add things to my agenda at this point).

The second, of course, is the more critical "And Then What?" discussion.

As it turns out, for all of the wonderful electronic planning tools out there (some I really do need to learn to use), I plan best in a simple spreadsheet table.  Rows and columns work for me and the fact I can have multiple sheets within a single notebook make it easy to toggle back and forth on the same overall project.

I have organized my notebook (and high level actions) into four areas:

1) Closeout Money - This relates to anything involving money between now and the end of my employment - in other words, no cash left on the table.  This includes things like filing our 2022 taxes (done), make sure all our receipts are submitted for our medical reimbursement (and indirectly, that anything else that we will need in terms of doctor/ dentist visits and reimbursements gets done before 29 May), 401(k) transfer out, budget review, and a revised cash run rate estimate.  Although these activities may cover the full time, they should not extend beyond 30 June 2023 (with the single hope that those tens of thousands of currently worthless stock options do something that might generate a little money -a vain hope, but I have until 27 August 2023 for that to happen: who knows?)

2) Job Search - Sadly, I am neither independently wealthy nor of a sufficient age to engage Social Security, so I will need some kind of other job.  This is the category for things like CV updates, social networking updates, and the mechanisms for a job search. There is no end date on this activity of course, until some kind of job is secured.  I would be wrong to say I am necessarily doing it with a high level of confidence, but I fear if I wait too long things will get difficult or even impossible - the market in my industry is shedding jobs at a terrific rate.  The other part of this is planning for some sort of short term part time job.  Anything to extend the cash runway.

3)  Find Money - Frankly, I have to assume that things will not go swimmingly and there will not be an immediate opening (even if there is: Plan for success and failure).  Which means that I need to see what else I have lying about that, frankly, can be converted into cash.  This is not digging into any of our savings or emergency sorts of things, but rather the things that might have some importance in a "employed" scenario, but none at all in "unemployed one".  As above, there is no end date on this activity:  Frankly, it is something I should just be doing.  

4)  Explore Writing - One of my long-time friends (long time as in "almost here from the start of the blog" friends) Rainbow, has suggested to me for years that I should be a technical writer for Biopharmaceuticals.  She believes - to be fair, perhaps more strongly than myself - that I really have the experience and background to provide a service.  She has suggested this for at least four years, and my response has always been "Well, I do not think I have the experience".  But then, she let me know her mentor was having a five day boot camp for the very reasonable price of $50.  

Why not, I thought?  I signed up - before I got laid off, as it turned out, and so ended last week not only without a job, but with a series of suggestions, slides, templates and the admonition "there really is a market for this (Website is here).

Do I think I can do it?   I have no idea.  Soliciting work is so far outside of my wheel house that the thought astounds me - and, frankly terrifies me.  I am not good with rejection.  I do not think I have the experience people "want".  On the other hand and at this point, what do I have to lose?

So I am starting out slowly.  I have the classes and slides and will finish those out first (sadly, I missed "Marketing Day" because we were preparing to get laid off).  I can find a way to build a website and generate an LOI from a template.  And go from there.  End date?  Who knows - until I either fail, succeed, or give up.  

So this is the plan for now, anyway.  I am modifying as I go - for example, if my last major job search was any indicator, after an initial bolus the ability to find positions that are feasible become fewer and farther between, and thus take up less time, which will mean I need to have some other things to do to fill the time.  

Which is fine, of course.  This is one great adventure, with the added bonus that the off ramp is coming up although I do not now know where it is.

Hammerfall 2.0: The Kitchen Drawer

 One difference that I realized with this event - different from literally any other event in my life - is that this is the first one that TB The Elder is not present for.  I realized this today as I was randomly thinking about something associated with talking to people - "What would Dad have said?" suddenly popped into my mind.  

I am pretty sure I know, of course:  Sorry to hear it, you will be fine, your mother and I are here if you need anything.  It was just strange that literally, for the first time, he was not one of the first people I reached out to with such news.

---

The casualties slowly continue to mount on Linked Out.  Everyone is getting the same recommendations from one or more of the same people:  The initially phrasing of the posts (or the supportive posts) is pretty much a carbon copy.  The cross linking for others is thoughtful.

It does still make me sad though.  Every posting has a face (and possibly faces) behind it.  Certainly we are not talking end of the world devastation, but we are are meaningfully talking some element of life devastation.  I know the work these people put in, the long nights, the weekends, the supreme efforts in hope of achieving a better end - after all, we were making medications to help people - all to come suddenly to an end one Thursday afternoon.  All that efforts - lost sleep, lost time with family and friends, high levels of stress - gone as if it never mattered.

Dear Industry:  If you are looking for a reason people become loathe to give you more than minimal effort, start here.

---

One of the activities I performed to help me get perspective on all of this is to make a list of the good things that this job helped me to do:

- Allowed two of three children to finish their school at a Christian school.

- Allowed all three children to start and finish high school at the same place.

- Allowed us to fully help the two older ones complete their college education and put the third one in a strong cash position for her school.

- Allowed us to travel to Iceland, Costa Rica, and the upcoming vacation in June.

- Allowed us to largely pay cash/completely pay off two cars.

- Allowed me to travel to Japan 3 times to train (would have been more, but The Plague) and supported the same number of training sessions with the head of our school traveling here.

- Allowed me to take up hiking, going to the Grand Canyon and Mt. Whitney and other smaller hikes.

- Allowed me to get the equipment I needed for Iaijutsu, including two more formal sets of gi/hakama, a 3 shaku iaito, and fitting out my 3.2 shaku shinken.

- Allowed me to get training programs and use a gym for weight training.

- Allowed me to change careers and keep my then current company.

- Allowed me to get a certification for my new job role.

- Allowed me, as part of that job change, to be able to go back to Old Home to see my parents once a month and then, once both of them had to go into retirement homes, continue to travel back and see them once a month.

- Allowed me to support my family better than likely I deserved.

Any two of those things would be amazing.  The fact that all of them happened is even more amazing.  Even if things are a little harder from here on out, there are memories embedded there that will well outlast my life time.

It is okay to be bitter about how things ended, but I should not let that remove all the good things that happened for 6.5 years until that last moment.

Hammerfall 2.0: Aftermath

 I have made an agreement with myself.  I will allow myself to write (and maunder) about being terminated for three days.  After that, time to move on.

The damage at my now former employer continues to spill over as word of who is leaving and who is staying spread.  Entire departments were cut by 80 or 90 percent (or 100 percent, in our case).  The Linked Out notices started to appear - both the ones with employees let people know they were now looking as well (somewhat surprisingly) as former employees reaching out to let people know to reach out to them if there was anything they could do. 

The Social Internet, at work again.

I touched bases with several now "in the process of becoming" former coworkers.  In every case, the tales that I heard were the same:  departments laid low, a sense of sadness as long time coworkers were suddenly cast adrift - I say long time; we had a surprising amount of people that had been in place for 2-3 years or more, which is rare in this industry (or at least was rare, at least once upon a time).  New Home is no Mecca for biopharmaceutical work; likely some or most of these people will have to find jobs somewhere else and uproot themselves.  A very few (like me) may be able to find remote due to the nature of what we do.

How am I feeling?  Rather distressingly, I find myself somewhat in the throes of a certain anger and bitterness.

Why?  The more I dwell on it, the more patently ridiculous this whole thing seems.  The signs that something needed to change were there 9 months ago.  Yet nothing was done.  Hard decisions were not made and no-one acted as if we were in the fight of our lives.  The assumption, I believe, was that additional monies were out there to be raised.  That narrative had really not been true for most of 2022, but was definitely crushed by the Silicon Valley Bank fiasco - if you have not been tracking the IPO and early stage financing market, let me assure you that it is considerably constrained and getting worse.  As a poster yesterday noted, the era of easy money is gone.

And we were counting on easy money.

The whole thing has been mishandled from there.  There is no master listing of who went and who stayed, putting individuals in the position of having to have difficult personal conversations.  There is an impact to this of course:  in 60 days (or less) people will suddenly disappear and no-one will have ready access to their files or things they did to make things work.  Those departing are more interested in finding their next job (no surprise there); those remaining are faced with the daunting task of both managing ongoing activities as well as planning for work that they will have to accomplish with far less personnel.

Many of these peoples were friends, both the departing and the remaining.  This hurts.  

And it could have been mitigated long before.

Part of what I need to do - both in this writing and in general - is to expunge my soul of all of this.  As of Thursday, this all is now in the past.  The future. is what I need to be paying attention to now. a future that has more possibilities than I had anticipated.

But still, it stings.

Hammerfall 2.0: The Day Of Long Knives

One of the things that I have made a habit of since 2009 is doing my best to be aware of what is going on at any company I work at - not just the mechanics of the company at work, but the actual status of the company as it functions - "making the sausage" that almost no-one cares about.  Mostly this is a defense mechanism:  I was caught unawares that "all is well" when in fact all was not well, and a number of events were precipitated by my trust in my management, including ultimately the relocation from Old Home to New Home.  And so, beyond my regular job, I pay attention to things like who is leaving and what organizational structures are doing and the quarterly finances. I spend a far amount of time in relationships with other employees - because no-one person has a view of everything that is going on.

So when one of my work friends reached out with "Did you see the e-mail from HR?" and I in fact did not have an e-mail from HR, I was not terribly surprised.  Something was up, something that would be manifesting itself in the next day or so.

I have been somewhat open here that I have had some ongoing concerns about my employment for awhile.  This is not unusual in the start-up Biopharmaceutical world:  I have likened it before to a roulette game where one hopes that one hits the number before the wheel stops spinning (e.g, runs out of money).  It is just one of those things that one accepts:  Higher reward, higher risk.  And so I have been eyeing our quarterly financials and our project progress and where we are spending our time and our energy.

And so, my friend letting me know there was a meeting involving HR was not surprising. And the fact that apparently bad news was forthcoming was not surprising either.

There is nothing worse than knowing bad news is coming and not being able to talk about it.    One waits, watches e-mails transit the system and requests for information that all of a sudden seems not as critical as it once was.

The day - yesterday - rolled around.  I knew the meeting invite was coming but it did not appear and did not appear and did not appear.  E-mails slowed down to a crawl, and then to none at all.

Finally, at 1300, the invite came out.  Mandatory company meeting, 30 minutes, no agenda. The proverbial cat was out of the bag.  E-mail, of course, slowed to a crawl.

The meeting itself was a mere 4 minutes:  all cameras disabled, all microphones disabled, not chat.  Short version:  Terrible times caused by the financial markets, major restructuring and refocus.  50% of employees (over 100) to be laid off.  Communication by e-mail and then by managers.  And...done.

And then the waiting.

My little pod of PMs waited.  Did you get an e-mail?  No, did you?  Meanwhile my phone keeps buzzing as I am responding to a different discussion with work friends, to the same end.  Did you hear?  No, did you?

The "it sounds like e-mails are coming soon" stretched into 1.5 hours, until finally the President reached out to me.

Terminated.

The letter came right after that, of course.  Effectively 8 weeks (60 days) until D-Day, during which we are expected to "turn over" our responsibilities to new people - whom, I have no idea.  My entire department was laid off so there are no Project Managers to turn it over to.  Last day 29 May 2023, last day of insurance 31 May 2023.  PTO to be paid out, which may give me another three weeks of income.

I have no idea of the total spread, but over 100 people will adversely impact almost every department.    Who will be doing the work we used to do, I have no idea.

Frankly, I no longer care.

How am I doing? Okay.  This did not come as a total surprise.  Perhaps I had some small hope that I would be spared this round - I have been spared others - but this was not the case.  And frankly, I am a little burned out at this point.  Last month we got the main thing I had working on for the last 22 months through; this month I am dismissed. A career of projects that do not go anywhere wears on a person after a while.

We are in a far better position than we were in 2009, when I was last laid off:  The Ravishing Mrs. TB has a full time job, the last child - Nighean Dhonn - will graduate from high school in a month and has at least the first two years of college covered - and we owe far less on our house than we did (and no other debt).  For sure there is a complete re-examination of the budget going on as we speak.

A funny story to close this out:  when speaking to folk months ago about this possibility, I said that my biggest hope was for my current position to last through Nighean Dhonn's graduation from high school as I would have liked (if possible) to let her attend all four years at the same high school.  My job "ends" on 29 May; she graduates on 25 May.  

God's providence or God's sense of humor are on full display.  Or perhaps, both.