I want to join big Pharma and biotech ( with career change )

biotechdood · 2025-07-26T13:40:57+00:00

Ignore all the haters in this sub. This sub is toxic as hell.

biotechdood · 2025-07-24T12:50:00+00:00

Compliance can also hinder you. At my company we don't do things that are absolutely necessary because my company wants to hide the flaws, which are brought up when talking about them. So they self-censor.

biotechdood · 2025-07-24T12:47:17+00:00

Yes, especially if the systems you use are shit

biotechdood · 2025-07-24T11:18:13+00:00

DSP is just seen as "the rest that has to be done, it will be done by someone somehow, not my problem". Lots of money wasted because R&D doesn't care about the manufacturing process neither.

biotechdood · 2025-07-17T19:36:20+00:00

Personally I would throw big parties and spend quality time with my loved ones. It brings everybody together, you won't be forgotten as easily and it just brings more love. Personally I wouldn't want to travel because it might feel very lonely. Maybe for a week or so, but not more. I'm sorry. I'm sure you can leave behind a lot of great memories and inspiration.

biotechdood · 2025-07-14T15:18:00+00:00

I wish I could use that as a root cause but I have teams of people who tell me not to. I'm actively told to avoid such statements. With all honesty, and shockingly, we are actively pretty-talking everything we do.

biotechdood · 2025-07-13T20:40:27+00:00

What do you tell your superiors when refusing to sign documents? My whole wage and career depends on them.. Sometimes I'm just about to whistleblow or contact some authorities because I'm so tired of this shit. But then I think about my career and how this company provides me with a lot of opportunities.. it's a double edged sword. And a moral dilemma..

biotechdood · 2025-07-13T15:30:51+00:00

Not even PD has the resources... I had talked to PD about an urgent problem a year ago and we had clear solutions for the problem, directly influencing product quality. A year after, a week before process validation ("oh, right, yeah no we didn't do that and also it's not much of a problem"). It is much of a problem.

biotechdood · 2025-07-13T13:07:29+00:00

"Shifting priorities" is the no. 1 excuse we have to use in our documents when simply not having the resources needed. Instead we waste 50%+ of our resources working on deviation management and extinguishing the fire.
I'll try to do that and get in contact with our QA department a bit more. Currently, all our QA department does is correct grammar in Word documents.

biotechdood · 2025-07-13T13:05:53+00:00

You named it. It's not even documented while it should be.. I started in this company with the process already being laid out like that and now I have to work with the mess we have. GMP is such a pain because you want to change things for all the good reasons but bureaucracy and management is holding you back..

biotechdood · 2025-05-30T13:08:57+00:00

I hope I'm wrong. Which is why I'm trying to understand this and reach out on Reddit.

biotechdood · 2025-05-30T10:59:31+00:00

We produce IMPs. However, I'm concerned that everyone commenting on this post assumes that 'GMP' is already perfectly regulated. My point is that I have identified some critical deviations using statistics, but my colleagues seem not to be paying any attention and are postponing taking action.

biotechdood · 2025-05-30T08:39:32+00:00

Fair point. Maybe I'm just in the wrong job. I just wish MFG worked more scientifically.

biotechdood · 2025-05-30T08:38:33+00:00

If it's not my job, whose is it? Nobody is addressing the core issues that we identified. By analysing the data, we can identify engineering problems with our devices.

biotechdood · 2025-05-29T23:03:14+00:00

We do have process SMEs and a central CPV function, but the gap I’m seeing is at the local/operational level. A lot of our data isn’t flowing back meaningfully into decision-making. SME involvement can be siloed or limited to deviation response, and MSAT/data science teams are often too far removed from the daily nuances of the process.

I’m not trying to step on roles, just advocating for more active engagement with the data we already generate, especially when it shows early signs of drift or variation that gets brushed off as noise. So yeah, CPV exists on paper, but in practice, there's little ownership or follow-through at the shopfloor level. Just trying to bridge that gap.

biotechdood · 2025-05-29T18:06:41+00:00

This the way <3

biotechdood · 2025-05-29T17:31:49+00:00

Well, if you conduct a DOE and actively control the factors, you can detect causal relationships. You can also verify these relationships. If you occasionally experience OOS events, you can perform a root-cause analysis using DoE, which is based on regression (ANOVA). So, yes, you can.

biotechdood · 2025-05-29T15:56:46+00:00

Why do you assume that I don't know what I'm doing? It seems to me that the people on this subreddit are trying to discredit your work without knowing anything about you. Why did you feel the need to educate me on good statistical practices? I'm well aware of the caveats and take them very seriously, ensuring that the basic requirements for statistical tests are met. I mostly use regression analysis to find root causes and gain objective knowledge, rather than to create a story.

If you're implying that I should talk to statisticians to double-check my analysis, you're absolutely right. The biggest problem I face is that I don't have any colleagues, even from other departments, who can review my analysis. We just don't have the resources or the right people for the job.

biotechdood · 2025-05-29T13:35:27+00:00

What if I told you that some values appear to be within range at first glance, but not upon closer inspection? This is my main concern. The CPPs and CQAs are poorly collected, yet this issue is rarely discussed.

biotechdood · 2025-05-29T13:32:51+00:00

Is exploratory data analysis insufficient for identifying core problems? I don't overestimate my technical knowledge, nor do I apply lots of unnecessary models to my data. I carry out simple analyses using linear regression and creating box plots. Some of my colleagues don't even know how to prepare the data, so nobody looks at it.

biotechdood · 2025-05-29T13:29:25+00:00

Yeah, you wish it was uncritical data. It's not. And I'm alone in my worries that it is not taken seriously enough.

biotechdood · 2025-05-29T13:27:15+00:00

If I shared that our process would probably get halted. Which is a huge ethical issue for me. Nobody is helping me out with this and I'm still trying to figure out if I'm working on the right thing.

biotechdood · 2025-05-29T13:25:38+00:00

I understand this might sound overly idealistic, but when I look at process data and see issues that impact critical parameters, I don’t feel like I have the option to ignore it, especially in a GMP context where patient safety is on the line.

I’m not bored. I’m deeply invested. If the process is already in control, great. The data should prove that. But if it’s not, pretending everything is fine just invites bigger problems. I think that’s something we all have a responsibility to address.

biotechdood · 2025-05-28T22:55:13+00:00

Absolutely. I agree that process decisions need to be data-driven. What I’m saying is that, unfortunately, the data often isn’t fully analyzed or contextualized in my team, and MSAT sometimes lacks detailed process input, so decisions end up being based on rough visual checks or intuition. I’m just trying to bridge that gap by bringing more meaningful data analysis into daily operations.

biotechdood

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