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Thanks. And here I would have guessed the FDA wanted drug manufacturers to watch processes more closely than most chemical manufacturers. I’d be surprised if I ever saw a CofA on a bottle of reagents as rough as USP 233. But then again, supplier quality engineers are actually seeing CofAs, unlike the people buying the drugs. Our product is niche, but suffice to say the process is completely new and trace metals content is very relevant so yeah we had to work with our analytical team.
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May 28, 2021 04:49
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If the consumer doesn't care and more data gives the bureaucratic cops more ammo to hassle you with...
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May 28, 2021 06:07
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teardrop posted:Thanks. And here I would have guessed the FDA wanted drug manufacturers to watch processes more closely than most chemical manufacturers. I’d be surprised if I ever saw a CofA on a bottle of reagents as rough as USP 233. But then again, supplier quality engineers are actually seeing CofAs, unlike the people buying the drugs. In other words, the more data you collect, the more chances you give idiots to nitpick that data. Also, of course the analytical chemists are collecting the <LOQ data and analyzing it for trends. They're analytical chemists; they live and breath that stuff. They're just not reporting it to you.
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May 28, 2021 12:00
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Dik Hz posted:Also, of course the analytical chemists are collecting the <LOQ data and analyzing it for trends. They're analytical chemists; they live and breath that stuff. They're just not reporting it to you. If it’s gmp data we absolutely do not analyze it for trends unless required to do so. If you want to analyze that data, first you ask QA or QC management whether it’s appropriate to even generate or capture that data.
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May 28, 2021 13:06
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Dik Hz posted:
As a hybrid R&D and analytical chemist, I'm gonna avoid doing that extra work. Too much other data analysis to worry about. I'll just shove it in my database vault and look at it if someone asks. Chat about LOQ data taught me something at least. Always wondered why material CoAs have <spec values that just seemed way high for a given analyte. Mustached Demon fucked around with this message at 13:19 on May 28, 2021 |
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May 28, 2021 13:12
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Mustached Demon posted:As a hybrid R&D and analytical chemist, I'm gonna avoid doing that extra work. Too much other data analysis to worry about. I'll just shove it in my database vault and look at it if someone asks. I'm not saying a thorough formal analysis. In my experience, the analytical chemist knows what the value normally is, what it was for that run, and which way its trending.
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May 28, 2021 13:36
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Dik Hz posted:Fair. Ah yeah the analytical chemist version of the mental note for sure. Those sort of casual observations are usually first signs of something going bad on the instrument. Yes we obsess over stuff like that. Several routine analysis via ICP-OES I can point out where the intensity counts are supposed to be, for instance.
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May 28, 2021 13:48
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Dik Hz posted:I'm not in Pharma, but oh god do I hate explaining natural variance to non-technical people. Some self-important fart-huffer will get his panties in a wad because the Manganese concentration doubled in that run. We need to do a full investigation! Nevermind that it's at 0.001% of the report value instead of 0.0005% and the natural variance of the measurement is 0.02% of the control value. I wish, our analytical chemists are overstretched and management keeps forgetting they need time for anything other than GxP QC. Also establishing a new process so no historical data yet. Going from reporting 50% to the process chemist/engineer to 0.001% to people who can’t definite std dev is a jump, point taken about getting bothered over results down in the noise, but here is definitely erring on the side of too little data. I would think only quantifying >50% seems inadequate in general for statistical process controls and thus my surprise to hear it is seemingly widespread at “highly regulated” companies. But if people are putting blinders on to avoid opening any can of worms, color me shocked to find a perverse incentive showing up in business I guess
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May 28, 2021 14:01
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teardrop posted:I wish, our analytical chemists are overstretched and management keeps forgetting they need time for anything other than GxP QC. Also establishing a new process so no historical data yet.
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May 28, 2021 14:12
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OK, the business group or a naive consumer doesn’t need any data beyond green/yellow/red. But isn’t SPC is a thing all over? Which means someone needs to be getting and analyzing numbers. Unless that is being glossed over at billion dollar pharma companies just like my 250 person job.
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May 28, 2021 14:24
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teardrop posted:OK, the business group or a naive consumer doesn’t need any data beyond green/yellow/red. SPC is pretty much a green/yellow/red system as well for most people. The yellow can be any alarm features, like n-sigma deviations, just half way to the spec limit (red line), or whatever else. The actual setting up of the chart and validating it will involve analysis of the numbers though. Once a process becomes stable, it's just kind of left alone unless it trips an alarm.
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May 28, 2021 15:00
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Right but my point of confusion is if everything up to that halfway line is treated as the same number, <50%, there is no sigma analysis or anything. It’s like a chart of just 0s.
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May 28, 2021 17:52
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Alright I'm officially job hunting in the bay area or full remote anywhere else in the US for a LIMS admin position. I already checked out Genetech and didn't see any open positions that matched. If anyone has any other leads I'd love to hear about them. Now I get to try and find a not completely terrible recruiter.
Spikes32 fucked around with this message at 00:09 on May 30, 2021 |
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May 29, 2021 21:25
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Spikes32 posted:Alright I'm officially job hunting in the bay area / full remote for a LIMS admin position. I already checked out Genetech and didn't see any open positions that matched. If anyone has any other leads I'd love to hear about them. Now I get to try and find a not completely terrible recruiter. Yeah you're not likely to get that at Genentech right now. Roche leadership sent out all kinds of e-mails during the pandemic informing us that no, full-remote would not be acceptable except in very limited cases, so expect to go back into the office when possible.
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May 29, 2021 23:53
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Sorry I wrote that poorly. Looking for either an in office job in the bay area, or full remote anywhere else in the US.
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May 30, 2021 00:09
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Spikes32 posted:Alright I'm officially job hunting in the bay area / full remote for a LIMS admin position. I already checked out Genetech and didn't see any open positions that matched. If anyone has any other leads I'd love to hear about them. Now I get to try and find a not completely terrible recruiter. We are always hiring PMs/BAs if you want to potentially work for a LIMS vendor. You would be WFH but I have no idea if you could negotiate a bay area salary to make it worthwhile or not.
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May 30, 2021 00:09
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Where are you based so i could get an idea of what the pay band for that would be?
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May 30, 2021 00:11
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Spikes32 posted:Where are you based so i could get an idea of what the pay band for that would be? NJ. They definitely take region into account but not as much as may be needed. BAs probably make $90-110k or so.
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May 30, 2021 01:14
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That's good to know thanks. My partner got the position up there but we won't have to move for 4 to 6 months as he can continue working remotely for a while. I'll see what I can stir up locally first.
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May 30, 2021 01:59
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Anyone ever work for a super small startup? I just interviewed last week and it seems like I'm going to get an offer. I've set the floor to be about a 30%-35% raise over my current base salary and they didn't have any concerns with that. There is also an equity component to the offer that I don't know the details of yet. Here's my dilemma: I've got options with my current company that are worth about 1-2x my annual salary vesting through the end of 2022. I also get RSUs and options granted as long term incentives. I'm a bit unmotivated and disengaged in my current position which is why I interviewed, but there's a lot of expected change for me in my role this year which should help with that. I'd be employee #10-30 which could be exciting but I know it's going to be a ton of work. I also don't know what the science behind their idea is yet and that'll get disclosed before I have to decide if I want to take the offer. Any thoughts? I think I should just hang out with my golden handcuffs for another year and a half and reevaluate but I do like the people I interviewed with and wouldn't want to close doors with them by declining an offer..
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Jun 2, 2021 23:58
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I assume your options are real salable stock and not some hypothetical pre-IPO thing etc. If you might be ok staying to let those options vest, then total those up and calculate your total compensation. 3x base salary seems good. Compare the new offer to that and see if that’s a dealbreaker. If the comp is fine and you think you would be happier at the new company, then why not? You almost always have to leave behind some vesting. But if you don’t have startup experience, be warned. Would you miss being somewhere with a deep bench of expertise? Would you have to wear a lot of hats and never get to do the science you love because you are stuck doing a bunch of regulatory and operations stuff whenever there is a problem? Maybe chat up someone with startup experience to get a feel for how that fits you. Also “I decided that I need to stay where I am right now” should never burn bridges anywhere you would want to work.
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Jun 3, 2021 21:43
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Appreciate the input. 100% overthinking it but I haven't worked for such an early stage company. Worked for a few that are "run like a startup" (aka cheap) or are super small and established and had mixed experiences. Real stock options currently, but a pretty volatile price. Hard to evaluate because I won't know what the platform actually is until next week. Once that happens it might be easier to think of it as a good opportunity. Also might be having kid number 2 within the year, so this whole startup thing popping into my lap right now is throwing me.
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Jun 4, 2021 11:13
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Do we have any Process Chemists (RD&E) in this thread? In my current job as a process chemist, my experience has involved a lot of micro-management. There is a large team of stakeholders watching me work and wanting to make most of the decisions. Is that typical to process development, or have I had an unusual experience here? I am trying to decide whether to focus on process or product development for my next round of applications. I had a lot more autonomy and ownership in my previous job in product development, so I might focus on that even though my resume is weaker there.
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Jun 6, 2021 22:15
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Lyon posted:NJ. They definitely take region into account but not as much as may be needed. BAs probably make $90-110k or so. I gotta say I'm surprised by how many lab vantage and starlims positions there are out there compared to labware. It's probably 50% labvantage, 30% labware and 20% starlims / benchling. Any idea how difficult it would be transitioning from labware to labvantage?
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Jun 24, 2021 20:05
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It’s very different technology wise but LIMS is LIMS. As long as you know what problems it can solve and which ones it can’t I think you’d be fine in a business analyst type role and if the company is willing to train you then you’d pick up LabVantage fast and could be an admin pretty quickly. We’ve been absolutely demolishing LabWare and StarLIMS and both will probably cease to exist as real companies in the not so distant future and will probably just ride out their support contracts for a decade.
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Jun 24, 2021 21:39
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How much actual travel time is expected for the business analyst position you guys currently are hiring for? It says 50%+, is that accurate?
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Jun 25, 2021 01:45
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I’d highly doubt it. I think that would be the max you could ever expect to travel in a month. BAs usually only travel for the initial kick off meeting and then it’s pretty much all remote. There are exceptions of course if you get a couple of new projects at the same time or if a major project needs more than one on-site etc. If you do want to apply to LabVantage let me know and I can submit your resume to the guy who manages the BAs. There are also tons of “internal” business analyst positions in industry for implementing and managing lab software systems that you could look for.
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Jun 25, 2021 03:39
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I've been applying to a bunch of those, just trying to figure out if I should apply to the ones that specify labvantage stuff as well. That led to considering if it would be worth the travel requirements to work directly for you guys.
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Jun 25, 2021 03:57
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Anyone know much about the lims consulting company CSols? I'm interviewing with them atm and got some ok vibes, but know some consulting firms can be brutal.
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Jul 9, 2021 14:31
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We work with them frequently, I’ve got colleagues who work or worked for them. If you’ve got specific questions I can probably get you answers, same for Accenture’s LIMS/life sciences group.
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Jul 9, 2021 14:47
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No specific questions at this point, more hoping to avoid any pitfalls or a toxic workspace if it is one.
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Jul 9, 2021 14:53
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Spikes32 posted:No specific questions at this point, more hoping to avoid any pitfalls or a toxic workspace if it is one. I've never heard any major complaints from the consultants who work there. One of their sales reps quit due to a conflict with the owners about pay/commission. I only heard his side so obviously the owners were toxic and in the wrong but that's really the only major negative information I ever heard about them. They do force us to do these awful full day software demos but that's wouldn't really be a problem for you  .Edit: Does anyone know of good industry forums for pharma, food and beverage, oil and gas, etc.? Lyon fucked around with this message at 16:35 on Jul 9, 2021 |
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Jul 9, 2021 16:21
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If there are any good pharma forums, I don't know about them. I used to get some info from biofind once in a while, but they've been shuttered for like a decade now. The only other one I know is CafePharma, and it's a shithole so deep you'd think it was a 4chan side-project.
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Jul 9, 2021 18:24
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Lyon posted:I've never heard any major complaints from the consultants who work there. One of their sales reps quit due to a conflict with the owners about pay/commission. I only heard his side so obviously the owners were toxic and in the wrong but that's really the only major negative information I ever heard about them. They do force us to do these awful full day software demos but that's wouldn't really be a problem for you Awesome appreciate it
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Jul 9, 2021 20:21
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Sundae posted:If there are any good pharma forums, I don't know about them. I used to get some info from biofind once in a while, but they've been shuttered for like a decade now. The only other one I know is CafePharma, and it's a shithole so deep you'd think it was a 4chan side-project. The comment section for ‘in the pipeline’ blog is great. Not exactly a forum, but one of the better communities out there. And highly informed.
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Jul 14, 2021 13:21
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So my current employer does a regular pipetting and volumetric flask refresher. Failed it, which is annoying but ok I can redo it tomorrow, asked what I did wrong and had this conversation. Trainer: “Your %RSD was too high” Me: “Really? They are better than the ones i had last year” Trainer: “Oh we changed then last week” Me:  Trainer: “We all were on the fence about the QS on the flask and in-fact all picked different ones that were too high and too low” Me: “How is this fair? I failed because no one could agree what work was done incorrectly?” Trainer:”Well no one said it is fair” This job is pretty nice but seriously what the gently caress?
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Jul 15, 2021 19:32
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Shrieking Muppet posted:So my current employer does a regular pipetting and volumetric flask refresher. Failed it, which is annoying but ok I can redo it tomorrow, asked what I did wrong and had this conversation.
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Jul 15, 2021 20:15
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Shrieking Muppet posted:So my current employer does a regular pipetting and volumetric flask refresher. Failed it, which is annoying but ok I can redo it tomorrow, asked what I did wrong and had this conversation. I have had an auditor ask me to provide clear rationales for how Passing and Failing qualifications were decided in a training program. I want that auditor to visit your facility, and I want to be a fly on the wall during that question.
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Jul 15, 2021 20:56
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Sundae posted:I have had an auditor ask me to provide clear rationales for how Passing and Failing qualifications were decided in a training program. I want that auditor to visit your facility, and I want to be a fly on the wall during that question. Mercifully this is a GMP lite lab so were pretty free from auditor meddling but dear god that would be amazing to watch. Still I really need to get the hell out of the lab, it seriously destroys my sanity and self esteem.
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Jul 15, 2021 21:41
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Ugh, yeah, that's giving me flashbacks to my dysfunctional biotech job. Hope you can get out.
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Jul 16, 2021 01:09
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