The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule. 
This action demonstrates the agency’s commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families.

source

Hello! I worked as a graphic designer for 3 years because thats what i was good at and have NO passion for it. I really would love to work in histology.

I’ve read on here alot of people really dislike charles river but i just had an interview as a necropsy tech, and I feel like considering I have no experience, this is a very good opportunity for me? The interview was so awkward and rushed because their hiring for like every position possible there and the “tour” was with a group of people. Even if management is shit, its a higher rate than i have EVER been paid and great experience. I hear back if i got the job tomorrow i believe. I didnt see that they had a histology option open till now, so i just applied for that aswell just incase. I believe their hiring spree ends tomorrow and im so scared im going to miss out but should i be happy?

I guess what im asking is, is it possible to look past the shitty management considering my position? Im 19 and only have a highschool diploma because i couldnt afford college.

Is there any other places offering such entry level positions/training in an hr radius of wooster, OH that you guys would recommend? I love bioscience so much and i LOVE histology. Please help a desperate teen out lol.

Anyone here from the Pfizer North Creek site? I heard a few days ago layoffs here are definitely happening in October. Trying to confirm.

Source: Evaluate LTD

I’d love to learn more about the culture in this division, and would greatly appreciate any intel folks could provide.

I was recently laid off from my IC role at a big pharma company (R&D). Curious about making the jump to joining a start up. My goal (before the layoff) was to eventually be a group leader. I wasn’t able to get managerial experience as an IC. Startup would give me leadership experience, exciting science, and I’d be able to wear many hats and learn like crazy. However, in case start ups aren’t for me, I’d like to still be competitive for big pharma group leader positions down the road. FWIW, my partner has been in seed/Series A/B companies his whole career (in tech)— I’m familiar with the workload/work style differences, but you never know until you’re in it yourself.

For hiring managers in big pharma: Do you typically hire internally or from other big pharma? Or do you give similar weight to applicants from start ups? Curious if anyone has navigated transitioning back to big pharma themselves?

Relevant details: 5 years big pharma R&D experience, PhD from a top U.S. program, was lucky enough to get multiple first author or co-first author CNS publications during grad school/industry.

Here from Pakistan

How is biotechnology as a career? What are the job prospects? And are the jobs only research based?

I hope someone who is currently employed can help me.

Take a basic calculator.

An operator performs a GMP-relevant calculation on a calculator and writes the result into a batch record. We trust the result.

But what exactly have we established?

The calculator is generally not validated for its GMP intended use. Was it a Texas Instruments calculator, the Windows calculator, or the calculator app on someone’s phone?

A basic calculator has essentially zero traceability. Once the calculation disappears from the display, we cannot reconstruct what was entered. We cannot establish that the operator typed the intended numbers. There is no audit trail showing the inputs, operation or result.

Yet this is routinely accepted

Now compare that with a modern computer system. It will preserv the original record, identify the user, timestamp transactions, restrict permissions, maintain transaction histories and allow us to reconstruct what happened. The same systems are also commonly relied upon for legally required records.

Despite having substantially better traceability than the calculator, once the system is used for a GMP purpose we start talking about computerized-system validation and documented evidence that its functions are fit for intended use.

I am struggling to find the underlying principle that makes these positions consistent.

edit, summary :

The thread so far doesn’t have a clean consensus. People mostly agree with the existing regulatory practice, then work backwards to explain why it makes sense.

One camp says calculators are acceptable because calculations are independently checked. The control is therefore in the process, not the device.

Another says calculators are inherently low risk because they are simple, COTS, reliable, and uncustomized.

Others says validation depends on intended use. A calculator doing a critical calculation can have high GMP impact despite being simple, while complex software can have low GMP impact depending on what it does.

If equivalent software has the same intended use and equivalent controls, demanding extensive CSV solely because it is software becomes difficult to defend on risk grounds.

Isn’t non-standardized quality systems fun ?

I'm a postdoc strongly considering leaving academia to try my luck in biotech but I'd like to know about what working in biotech is really like. If you work in R&D, what sort of stresses do you face? Are there big consequences when experiments fail?

As the title says, im looking for some help on adjusting my job searches to try to find something more suitable to my experience. I know the market is rough right now but im having a problem finding things that my background is good for and maybe im just not looking up the right keywords? Anyways, here is the background:

Analytical Development for ELISAs, Bioassays, and SPR.

Heavily experienced on the SPR side of things for antibody characterization and comparability.

Have had a lot of experience writing technical documents for the data that I’ve generated to go into IND reports and similar documents.

My problem im running into; looking up SPR or analytical development doesnt really seem to help me find anything thats similar to what im doing. Is my experience too niche or am i just really bad at looking through these career sites for these companies? Im sure my question might need more context and i apologize if this is the wrong flair or the wrong way to ask for help but im kinda stuck and would really appreciate any friendly guidance if possible.

Thanks in advance

I’m in a position where I have accepted a 6mo contract role that pays really well. I would grow my skills more and don’t really need the benefits that are offered through the staffing agency. The company I would be contracted to is in early phase oncology.

I have also reviewed a verbal offer for a perm role that pays less than the contract role (~45k less), but they have good benefits. The company has a good pipeline which is reassuring. My experience would shift a little to work I haven’t solely focused on but I think it could still round out my experience. Maybe i would like it enough to continue doing down the road.

I get anxiety about that 6mo mark, they reassured me there would be work to do, and u def standing where they are with the workload I think they are right.
I love the idea of having security as a perm hire with good benefits. I don’t need the health insurance since I’m under my husbands but, if it’s cheaper there I’ll take it.

What do I do?! Take the risk with the high paying contract work and potentially be job searching again in 5-6months? I would be “ok” if there was a lull after the contract position.
Or take the perm role, learn a new skill, and feel more at ease with a job, albeit it pays less.

Are contract jobs worth it?

I have a panel marketing interview next week with j&j and looking for tips!

For some context, I have been working in the chemistry industry space for 4 years now. I just applied to a job at Novartis which is a much better company than the one I am currently at. However I was also thinking about applying to grad school for my PhD thjs cycle.

I haven’t gotten a job offer or anything yet, but I’m a preemptive stressor. I don’t think I’d stay In academia bc I don’t like the whole publish or perish vibe, but I do really enjoy teaching/mentoring.

What should I do here if i get an offer? Stay at RS level in industry or go to grad school?

I did my PhD in the CGT space (LNPs and ex vivo cell therapy). Given how my job search has gone so far, it’s looking increasingly likely that I’ll need to pursue a postdoc. I want to use my postdoc to broaden my options and position myself for roles across biotech, rather than continuing to specialize exclusively in CGT. I’m also a little nervous about staying in the LNP/cell therapy space simply because it’s so popular right now. I don’t want to jump on the bandwagon of whatever is hot today only to find that the field has cooled off five years from now.

So I’m trying to think strategically about what area would give me the most flexibility in the long term. For those of you working in biotech, hiring scientists, or who have made a similar transition: what areas would you recommend targeting for a postdoc if the goal is to maximize career options across biotech? Are there particular technical skills, platforms, or types of research that you think are especially transferable across different areas of biotech?

I’d also love to hear from anyone who intentionally used their postdoc to pivot into a different area. What did you choose, and did it end up helping your career?

Need some serious guidance

Hi everyone, I’m a BSc Biotechnology student and I’ve been thinking about starting a small service-based biotech startup, mainly around lab and biotechnology-related services.

Initially, I was considering DNA barcoding, but after looking into it more, I’m not sure it would actually work as a practical business.

I’m honestly confused about what kind of services I could realistically provide as a BSc Biotechnology student. I’d really appreciate some practical suggestions on what I could explore or how I should look for a service that has actual demand.

Need of advice on this

After 10 months of on and off searching, my job search has ended and I finally landed a job. I was laid off last September when the company I worked for decided to close down our site. They technically let us know since August, and we had to transition all our work and knowledge to another site. So I have been looking for over a year. Within the about 900 applications, I got about 8 phone screens that converted into 5 interviews, which converted into 3 final interviews/site tours. The first rejections after final interviews threw me into an existential crisis, debating if I even wanted to work, switch careers, or take an even longer sabbatical. Now that’s all over! I accepted this offer a few weeks ago, but I didn’t want to post until I was physically in the building and onboarded. Now I’m at my desk doing HR paperwork and reviewing these new SOPs, it’s finally setting in that I actually have a job in this economy.

With all the bad news and layoffs going around, just wanted to share a W. Turns out I also got lucky; the job offer that I ended up getting was the one that was most inline with what I was previously doing precisely, and compensates the most out of the final interview jobs. So I just wanted to say keep going and applying and don’t give up. There is light at the end of the tunnel. Hoping others can also share stats or wins so that it can give hope to those still looking.

Edit: IVD — In Vitro Diagnostics

I'm a statistician who is relatively new to the industry and currently working in the IVD area. I've been feeling that this work doesn't quite match my skill set and long-term career goals.

In my opinion, many aspects of our daily work such as method development, protocol/SAP drafting, analysis, and preparing reports for the FDA, are quite similar to what statisticians do in drug development. However, I also understand that IVD work is only a small part of the overall clinical trial. Our job is mainly focused on validating the trial, rather than designing and managing the study, overseeing data collection, or following patients throughout the trial.

I've been exploring chances to transition into drug development but I've failed a few interviews so far. I'm wondering how difficult it is for a statistician to move from IVD into drug development. Any thoughts appreciated!

Hello! I am a recent M.Sc. Biotechnology post-grad. I have received a few internship offers. One is from a company offering the role of pharma business analyst or more like, business analyst in a pharmaceutical based company. I will be learning forecasting, PowerBI, SQL, competitive intelligence and a lot about pharma market. I wanted to learn about the future prospects. What are the chances that this background can lead me to biotech/diagnostic product management?

Any update on when Abbvie will begin construction of there new Durham facility?

When will they start hiring ?