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Powerful Two-Hander
Mar 10, 2004

Mods please change my name to "Tooter Skeleton" TIA.


How can we be getting poo poo about a July deliverable that's pretty straightforward from a migration team and then when we query "ok so what about all this other surrounding poo poo our departmental users do that we don't control the delivery of and you need to solve for?" the answer is "well we're about to start looking at that but we don't know yet". Must be nice to live in a glass house and have so many stones to throw I guess!

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Sundae
Dec 1, 2005
Badly Designed Systems.txt...


1) Material arrives into warehouse from mothership. Warehouse receives it, adds it to SAP inventory. Puts it in "Quality Hold" status, and adds the vendor expiration date to the material (5 years).
2) Sundae has a campaign coming up, checks inventory, sees a Q-status material that matches what he needs in two months and the expiry isn't for 3 years. "Looks like we're good," he tells the ops team, and then he calls QA/Chem to release the quality hold.
3) Meanwhile, an automated check sweeps through SAP and checks for inventory safety levels. The material is there, in adequate quantity, and doesn't expire for three years. All good, it says, and it doesn't order anything new.
4) Chemistry/QA run the release testing on the material, and check the actual approved certificate of analysis from the mothership. They didn't use the vendor's expiration date, but their own internal one. They only give the material 1 year, not 5 years.
5) QA updates the material's expiration date. It expired before we actually received it now. The Quality Hold status converts to Expired.
6) Sundae finds out he has no material to produce the upcoming batch, and the mothership wants 6 months lead time on sending more material, because "why didn't SAP just order more if it was expired?"

:suicide:

What a dumb, dumb system. I'm sure it'll be easy to fix becau-- sees that it's a global quality standard defining the process -- gently caress.

Guy Axlerod
Dec 29, 2008
Yeah workday is fine for the PTO tracking we use it for. So obviously everyone outside the US has their own time tracking either in place of or on top of workday. So I get to do everything over email for most of my team.

Powerful Two-Hander
Mar 10, 2004

Mods please change my name to "Tooter Skeleton" TIA.


It's better than PeopleSoft!

Dango Bango
Jul 26, 2007

Work from home perk - logging off an hour ahead of schedule because I'm blocked on everything and likely won't be able to close a big deal I'm working on because of internal red tape.

knox_harrington
Feb 18, 2011

Running no point.

knox_harrington posted:

My R&D program is a corporate priority / goal which theoretically means it gets more and better resourcing. What it has actually meant so far is the head of clinical ops has hired a consultancy who take a "no stone unturned" approach to helping deliver clinical trials.

In addition to the first set of idiots I'm now getting emailed by a second set from McKinsey who have also been brought in to "accelerate" the program. Wondering if I can pitch the two against each other to use up some of their energy.

I did also discover the first set have never worked on cell therapy R&D before so don't understand the key constraints on the work. (I started in 2006, or maybe 2001 depending how you count it)

The fun background is that with personalised medicine like this, the rate at which you can enroll patients onto trials is wholly constrained by manufacturing readiness and supply.

Sundae
Dec 1, 2005

knox_harrington posted:

The fun background is that with personalised medicine like this, the rate at which you can enroll patients onto trials is wholly constrained by manufacturing readiness and supply.

Not specific to personalised medicine here, but one of my biggest peeves is how often projects set their clinical timelines before they even have a molecule sorted. We're supposed to somehow back-date from clinical deadline and that's just how much time we have to make it.

So, we'll be told that (let's say, WTF1 inhibitor to make something up) needs to be in clinic by June 15th. We have a starter molecule but no actual reliable synthesis pathway yet, no analytical methods, and the formulators haven't even been given material to do even material-sparing characterization/process batches, let alone pilot scale or actual manufacturing.

How do we make it? Don't know. What's the dose? Not sure yet. Is it a tablet? Probably but TBD. What's the safety profile for our workers in the lab? No idea. How many doses do you even need for this trial? TBD but somewhere between 2,000 and 200,000. What's the stability profile on the API? No idea. What excipients are compatible with it? No clue.

But when is it due? June 15th, definitely. Totally certain of that part.

Oh and good news, formulators... we have 1 gram for you to work with! FEEL SPECIAL.

It's this weird-rear end thing where we can't tell you when we'll be done because you (clinical, generic you) haven't given us poo poo to work with, and you can't tell anyone when you'll be ready until you have a timeline from us, but presumably some project manager or department lead told a VP that they'd have the drug in clinic by the 15th of June to meet whatever competitive intel guidance they have for competing drugs going to trial. It's such a bad way to do development, and thank god it's early-phase here because otherwise the FDA would probably shove a brick up my rear end with the letters "QBD" spraypainted on it.

Sundae fucked around with this message at 10:44 on Feb 3, 2024

Atopian
Sep 23, 2014

I need a security perimeter with Venetian blinds.
"Quite Bad dActually"?

Sundae
Dec 1, 2005

Atopian posted:

"Quite Bad dActually"?

Sorry. "Quality By Design" -- a set of design principles you're supposed to follow and flesh out to figure out what all the critical quality attributes, process parameters, etc etc are for a given drug manufacturing process. You're supposed to have good answers for what is critical and what isn't for your manufacturing process (including packaging, synthesis, shipping and storage), what variability in the process will do to it, how much room you have to spare, and generally have an experimental design space for which you've determined the impact of each potential variable to show that your product is robust over a good range of potential variance (or if it isn't, how you control the variability or beef up your detection process).

Giving a formulator barely enough starting material to even figure out a functional dose, let alone an ideal dose + qualified design space, is not gonna get you "quality by design" data. The FDA does not like late-stage projects or projects aiming for approval that haven't done their homework, and it hasn't liked it for literally 15 years now.

Edit:

So what I often get from formulators because of their resource constraints on API, is a single datapoint of a single run. They have a target. They MIGHT have a range if some sort of dosing study was done elsewhere (so at least I know if the range is 98-102% or 99-101% or 95-105% of dose, etc). But, they will have no idea how wide certain processing parameters need to be, how robust it is under certain circumstances, etc. They just didn't have enough material to test the design space, so I end up having arguments over the fact that it is impossible for me to run a zero-variability manufacturing process. They're not going to get 0% weight variability, or literally dead-on compression forces or blending torque or water addition rates during the process. What's the acceptable range? When I pull a sample mid-run to see what the weights are or the hardnesses of tablets, what is considered acceptable? If you give me a single number and no range, I'm going to fail the production run. That's just not how reality works; things aren't perfect.

After that, we'll settle on some (probably made-up) range that is extremely tight and makes our operators nervous to try to maintain since they have to babysit the equipment and process so much. We'll be sitting there trying to keep the weight within a range of 98-102% of target so that the API stays (assuming content uniformity) in the 98-102% range of effective dose as well, while keeping the thickness of the tablet at X mm +/- 0.1mm or something, with the hardness range of X +/- 0.5kp or something like that. Now we have three co-related variables (weight, hardness, thickness) all being artificially constrained to potentially impossible numbers (because the targets may only have been possible or using the exact lots of material used in the material-sparing studies -- the batch properties also depend on the incoming raw material properties, and different lots can vary drastically for early-stage APIs as well as for excipients), and we're trying to thread a needle with a giant, floppy piece of yarn that is exactly the size of the needle's eye. Oh, and probably no second chances because there isn't enough API for that, and because we couldn't run again and still hit June 15th.

Sundae fucked around with this message at 11:13 on Feb 3, 2024

knox_harrington
Feb 18, 2011

Running no point.

Sundae posted:

Not specific to personalised medicine here, but one of my biggest peeves is how often projects set their clinical timelines before they even have a molecule sorted. We're supposed to somehow back-date from clinical deadline and that's just how much time we have to make it.

You are right, as theoretical "owner" of a clinical development plan, a lot of it is driven just by what the commercial team wants rather than by science or other reality-based disciplines. There is a phenomenal advantage to being first to market for regulatory approvals, pricing and sales.

Unfortunately for everyone involved, the hard-won lesson is if you ask all the functions "when can you have X ready?" the answer will end up being a year or two later than the competition. Not just manufacturing: for operations, central labs, data management there are lots of competing priorities and don't bear the risk of delivering a drug approval in the same way a clinical development.

That said, maybe you can explain to me why it takes 9 months to package and label oral medication that is already manufactured?

Atopian
Sep 23, 2014

I need a security perimeter with Venetian blinds.
OK, QBD does sound pretty good.

Motronic
Nov 6, 2009

Sundae posted:

Not specific to personalised medicine here, but one of my biggest peeves is how often projects set their clinical timelines before they even have a molecule sorted. We're supposed to somehow back-date from clinical deadline and that's just how much time we have to make it.

So, we'll be told that (let's say, WTF1 inhibitor to make something up) needs to be in clinic by June 15th. We have a starter molecule but no actual reliable synthesis pathway yet, no analytical methods, and the formulators haven't even been given material to do even material-sparing characterization/process batches, let alone pilot scale or actual manufacturing.

How do we make it? Don't know. What's the dose? Not sure yet. Is it a tablet? Probably but TBD. What's the safety profile for our workers in the lab? No idea. How many doses do you even need for this trial? TBD but somewhere between 2,000 and 200,000. What's the stability profile on the API? No idea. What excipients are compatible with it? No clue.

But when is it due? June 15th, definitely. Totally certain of that part.

This is how non-technical product managers operate in poorly managed tech companies as well. In fact, it's startlingly close to what I've been routinely experiencing for the last 2 years.

How do they get their time estimates? From when something needs to be done to hit revenue targets/when a major customer wants it of course. Why would you talk to onme of the architects or an engineer? What would they know about doing the job they're going to have to do to make this fever dream into reality?

Anmd since there is no real QC in tech, this leads to lovely software and tech debt out of the box.

Roundboy
Oct 21, 2008
Why cant you just give out random doses to homeless people/ paid volunteers and see what sticks?

I think you are missing out on the early days of scientific discovery with all of these 'safety' rules. So some asbestos got in the baby powder. WHOOOPS, MY BAD, give them a coupon and the next one will be better.


It's just not that hard

Powerful Two-Hander
Mar 10, 2004

Mods please change my name to "Tooter Skeleton" TIA.


We just had a big blow up escalation because of concerns over delivery dates because the other half of the project from us announced two weeks ago that they would be starting integration testing right now before we've even started doing anything, and also by the way they have a fixed deployment date in May that's a month earlier than we thought was needed.

Also they admitted they still haven't finalised some of the cases they want us to handle because they have seven different scrum teams on this and they're all at different stages.

Agile strikes again :rolleyes:

Sundae
Dec 1, 2005

knox_harrington posted:


Unfortunately for everyone involved, the hard-won lesson is if you ask all the functions "when can you have X ready?" the answer will end up being a year or two later than the competition. Not just manufacturing: for operations, central labs, data management there are lots of competing priorities and don't bear the risk of delivering a drug approval in the same way a clinical development.

That said, maybe you can explain to me why it takes 9 months to package and label oral medication that is already manufactured?

True, if you ask everyone their timing, they’re all going to pad the timeline “just in case” and you’re going to miss the competitive window. Fair point. We are, collectively, why we can’t have nice things.

Nine months to package? :lol: For Phase 1, we do it in two weeks and that’s with a mostly manual process. Unless that clinical project needs like 500,000 bottles or something and management picked an all-manual process (which would be stupid), that’s a crazy timeline. Is it a contract packaging site? Is it using blister cards / needing something with pre-sets that they have to turn over the line for after other stuff is done?

The worst packaging op I’ve ever worked on didn’t take 9 months.

Sundae
Dec 1, 2005

Roundboy posted:

Why cant you just give out random doses to homeless people/ paid volunteers and see what sticks?

Stop giving Pfizer ideas!!

Fil5000
Jun 23, 2003

HOLD ON GUYS I'M POSTING ABOUT INTERNET ROBOTS
Clearly what you need is some sort of beach that makes people get old faster.

poisonpill
Nov 8, 2009

The only way to get huge fast is to insult a passing witch and hope she curses you with Beast-strength.


Euronymous posted:

Helps a lot with stuff like business requirement documents and bullshit boilerplate project management stuff. It's REALLY good at taking transcripts from long boring meetings and making summaries and action item lists. I don't code much, but when I have to, it really helps with TypeScript and SQL queries.

I'm not kidding btw, I'm so overemployed it's insane. I don't understand why everyone that could do it, doesn't

How do you deal with scheduling? Are you a coder? Is this at, like, real companies? I’m just blown away honestly

HiroProtagonist
May 7, 2007

Eric the Mauve
May 8, 2012

Making you happy for a buck since 199X
I'm just going to go right ahead and admit that the "Refer to laid-off employees as 'lazy' in email to remaining employees" checkbox is the sole thing in there that assures me that image is a work.

Volmarias
Dec 31, 2002

EMAIL... THE INTERNET... SEARCH ENGINES...

Eric the Mauve posted:

I'm just going to go right ahead and admit that the "Refer to laid-off employees as 'lazy' in email to remaining employees" checkbox is the sole thing in there that assures me that image is a work.

I was going to go with the Thanos bonus for snapping 50% of the employees, myself.

Referee
Aug 25, 2004

"Winning is great, sure, but if you are really going to do something in life, the secret is learning how to lose. Nobody goes undefeated all the time. If you can pick up after a crushing defeat, and go on to win again, you are going to be a champion someday."
(Wilma Rudolph)

The last checkbox not being grayed-out or struck through was what did it for me.

Guy Axlerod
Dec 29, 2008
No workday UI has ever looked that good.

priznat
Jul 7, 2009

Let's get drunk and kiss each other all night.
My ex-ex-company is putting in a 10% pay cut due to the current market conditions (they did this during covid too), and yet increasing the dividend. I love how that happens.

Boris Galerkin
Dec 17, 2011

I don't understand why I can't harass people online. Seriously, somebody please explain why I shouldn't be allowed to stalk others on social media!

priznat posted:

My ex-ex-company is putting in a 10% pay cut due to the current market conditions (they did this during covid too), and yet increasing the dividend. I love how that happens.

Market seems to be doing pretty great so it makes perfect sense to decrease your salary in order to increase payouts to the people that matter :)

E: But on a serious note, I’ve never heard of anyone or experienced having my salary just slashed. Bonus percentage reduced yes. Raise percentage reduced sure. But how does a company that hired you at 69,420/year just get to say nah we pay 10% less now?

Boris Galerkin fucked around with this message at 13:39 on Feb 4, 2024

Powerful Two-Hander
Mar 10, 2004

Mods please change my name to "Tooter Skeleton" TIA.



In future I will refer to browsing the internet at work as "UX research".

Previously I'd use "self directed learning" but that unfortunately doesn't count as CPD.

TraderStav
May 19, 2006

It feels like I was standing my entire life and I just sat down

Boris Galerkin posted:

Market seems to be doing pretty great so it makes perfect sense to decrease your salary in order to increase payouts to the people that matter :)

E: But on a serious note, I’ve never heard of anyone or experienced having my salary just slashed. Bonus percentage reduced yes. Raise percentage reduced sure. But how does a company that hired you at 69,420/year just get to say nah we pay 10% less now?

When they want people to leave but don't went to lay to them off

Mantle
May 15, 2004

TraderStav posted:

When they want people to leave but don't went to lay to them off

You could even call it constructive dismissal

Not a Children
Oct 9, 2012

Don't need a holster if you never stop shooting.

Mantle posted:

You could even call it constructive dismissal

Does it count as constructive if it’s not targeted at an individual?

Boris Galerkin
Dec 17, 2011

I don't understand why I can't harass people online. Seriously, somebody please explain why I shouldn't be allowed to stalk others on social media!
So companies can legit just say “we are giving you a 10% salary pay cut effective immediately” and there isn’t anything to prevent that? I get that the USA is a corporate hellworld where you can get fired because your manager thinks you might be gay and fire you as long as they were smart enough to never ever ever make any mention of that ever and just hand wave reasons like market conditions.

But salaries are negotiated and signed for. That means something no?

E: That’s why I brought up bonuses. My bonus pay explicitly gives a breakdown of how I can hit 100% of my bonus pay based on metrics including some that I have no control over. So when they decide to give me 50% of what I should get it’s “allowed” because I didn’t hit this metric, that conveniently nobody else in the company did either.

Boris Galerkin fucked around with this message at 15:47 on Feb 4, 2024

TraderStav
May 19, 2006

It feels like I was standing my entire life and I just sat down

Boris Galerkin posted:

So companies can legit just say “we are giving you a 10% salary pay cut effective immediately” and there isn’t anything to prevent that? I get that the USA is a corporate hellworld where you can get fired because your manager thinks you might be gay and fire you as long as they were smart enough to never ever ever make any mention of that ever and just hand wave reasons like market conditions.

But salaries are negotiated and signed for. That means something no?

E: That’s why I brought up bonuses. My bonus pay explicitly gives a breakdown of how I can hit 100% of my bonus pay based on metrics including some that I have no control over. So when they decide to give me 50% of what I should get it’s “allowed” because I didn’t hit this metric, that conveniently nobody else in the company did either.

I can't ever remembering 'signing' any contract with any job. They send an offer and verbally accept and you're off to the races.

America is a hellscape.

Motronic
Nov 6, 2009

TraderStav posted:

I can't ever remembering 'signing' any contract with any job. They send an offer and verbally accept and you're off to the races.

America is a hellscape.

You almost certainly have signed a conctract that is incredibly one sided. Most often it's part of your starting paperwork and it basically says that for the due consideration of your salary you agree to this NDA (appendix 1), that non-compete (appendix 2) and to be bound by the company handbook (appendix 3) which may be revised at any time.


Edit: Forgot appendix 4: the binding arbitration clause with a venue of the state of the home office, even if you report to an office on the other side of the country.

Motronic fucked around with this message at 16:09 on Feb 4, 2024

Boris Galerkin
Dec 17, 2011

I don't understand why I can't harass people online. Seriously, somebody please explain why I shouldn't be allowed to stalk others on social media!

TraderStav posted:

I can't ever remembering 'signing' any contract with any job. They send an offer and verbally accept and you're off to the races.

America is a hellscape.

That has never been my experience at any corporate job I’ve worked at. There is always paperwork to sign. What are you talking about?

Hotel Kpro
Feb 24, 2011

owls don't go to school
Dinosaur Gum

Boris Galerkin posted:

So companies can legit just say “we are giving you a 10% salary pay cut effective immediately” and there isn’t anything to prevent that? I get that the USA is a corporate hellworld where you can get fired because your manager thinks you might be gay and fire you as long as they were smart enough to never ever ever make any mention of that ever and just hand wave reasons like market conditions.

But salaries are negotiated and signed for. That means something no?

That is exactly what happened to me at the end of 2017 when the company I was with as a contractor decided they didn’t want to pay us as much. I took a 20% paycut along with a bunch of my coworkers as we were demoted from one pay band to the next one down. We were in a union too which is the best part

The company had to rebid on the contract and January 1st was the start of it, so they called us in to the office right after Christmas and offered us our jobs at a reduced rate, or we were told we wouldn’t have a job. Since our career field was tiny and the pay was still pretty good every person ended up taking the offer but within six months we had lost about 10 people as they went to the government side.

TraderStav
May 19, 2006

It feels like I was standing my entire life and I just sat down
Well, I have been at my same company for 17 years, but I have no memory of putting ink to paper on anything other than tax forms/etc. We negotiated back and forth over email and phone.

Or maybe I'm just an old man yelling at a cloud with bad memory and I'm misremembering.

pseudanonymous
Aug 30, 2008

When you make the second entry and the debits and credits balance, and you blow them to hell.

Boris Galerkin posted:


But salaries are negotiated and signed for. That means something no?

Almost all US employment is “at will” meaning you can be terminated at any time for no reason. Very few people have employment contracts in the US, almost all of Thomas’s that do are through unions, and unions have and unionization has been under attack forever.

Boris Galerkin
Dec 17, 2011

I don't understand why I can't harass people online. Seriously, somebody please explain why I shouldn't be allowed to stalk others on social media!

pseudanonymous posted:

Almost all US employment is “at will” meaning you can be terminated at any time for no reason. Very few people have employment contracts in the US, almost all of Thomas’s that do are through unions, and unions have and unionization has been under attack forever.

I understand this.

I want to understand what is the mechanism that your company can use to reduce your base salary pay when your offer letter that you signed states that you will get paid this much.

Take the pay cut or we fire you?

Otherwise why don’t all companies do this? I’ve heard of companies giving signing/starting bonuses. I’ve never heard of companies giving an introductory salary rate that later drops. If there’s truly nothing preventing a company from cutting your salary by 10% why don’t every company just cut by 10% after the first month? If everyone’s doing it then where is everyone going to jump ship to? But nobody is doing this, that I’m aware of.

Boris Galerkin fucked around with this message at 16:39 on Feb 4, 2024

Guy Axlerod
Dec 29, 2008
The only obligation they have is to notify you before the change goes into effect. They can't retroactively change your pay. No they don't always do that.

Boris Galerkin
Dec 17, 2011

I don't understand why I can't harass people online. Seriously, somebody please explain why I shouldn't be allowed to stalk others on social media!

Hotel Kpro posted:

That is exactly what happened to me at the end of 2017 when the company I was with as a contractor decided they didn’t want to pay us as much. I took a 20% paycut along with a bunch of my coworkers as we were demoted from one pay band to the next one down. We were in a union too which is the best part

The company had to rebid on the contract and January 1st was the start of it, so they called us in to the office right after Christmas and offered us our jobs at a reduced rate, or we were told we wouldn’t have a job. Since our career field was tiny and the pay was still pretty good every person ended up taking the offer but within six months we had lost about 10 people as they went to the government side.

Thanks for the info. By contractor you mean 1099? Can they do this for W2 is what I’m wanting to know.

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Motronic
Nov 6, 2009

Boris Galerkin posted:

Can they do this for W2 is what I’m wanting to know.

Yes. "They" can do anything they want.

Whether they will is a cost calculation: legal fees, potenmtial damages, increased unemployment insurance premiums vs. cutting your salary. Most places I've worked would rather lay off because that's a clear path to low/no liability and just increased premiums for them.

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