Posted on March 27, 2006 by BioJobBlogger

Jobs at FDA

During my recent trip to teach at Georgetown University, I suggested to the students who were taking my regulatory compliance course to consider pursuing jobs at FDA. The reason for this job choice is very simple: the FDA is a good place to "be from". Inotherwords, if you have FDA regulatory experience on your c.v., the liklihood of getting a sweet job in industry after the leaving the agency is very good. Anybody and everybody who runs a pharmaceutical or biotechnology company wants to hire at least one ex-FDA employee. This is because ex-FDA folks have magical powers that enables them to help a company get their drugs approved much more efficiently and cost effectively. But, alas, I digress....... The truth is that FDA is seriously understaffed and needs more reviewers to evaluate INDs, NDA and BLAs and it also needs more regulators to inspect manufacturing operations that range from biomanufacturing facilities to chicken farms. And, as fars as I can ascertain, a job at FDA permits you to learn a lot of regulatory stuff, allows you to work a 7:00 to 4:00 job and provides its employees with great medical benefits. But alas, I digress......... again. Now, back to the students in my class. After I put forth the brillant FDA job idea to my students, one person (there is always one who is thinking) asks me "So, how do you become an FDA inspector?". I paused for a minute and said...."You know what? I don't know"! Nobody had ever asked me that before....they always nodded their heads in agreement after I made the suggestion (I always thought that they were agreeing that is was a good idea....go figure). Tune in next time for sequel to this post entitled "Jobs at FDA: The Sequel" if you are interested in finding out! --------
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Posted on March 24, 2006 by BioJobBlogger

The Utility of Certificate and Master Degree Programs in Biotechnology

I just finished teaching a Biotechnology Product Development course for the New York Biotechnology center that is administered through SUNY Stonybrook. The SUNY program has evolved enormously over the past few years and I highly recommend it if you are the greater NYC metropolitan area. This is my third year as a course director and I still love teaching the course and meeting all the characters who are my students (believe me they are characters). I am continually challenged by the students and each year the quality of students who participate in the program improves beyond my imagination. One of the best features of the Stonybrook program, and other like it e.g. Georgetown University ,is that students who participate in the program have to make connections with biotechnology executives and employees. This occurs via attendance at local and regional biotechnolgy meetings, career fairs and even industry internships. As I mentioned in previous posts, it is "not what you know but who you know" that helps you land a job! That said, I highly recommend that you enroll in a local certificate or master degree program (if there is one available in your neighborhood). Making industry connections as a student certainly cannot hurt when it comes to job hunting after graduation. Also, if you are lucky..... you may have me as a teacher.... as I have been known to show up in the most unusual places to teach biotechnology product development and other arcane aspects of the biotechnology biz! --------
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Posted on March 21, 2006 by BioJobBlogger

Biomanufacturing:Where the Jobs Are!

Industry analysts estimate that job growth in biomanufacturing has averaged about 10 percent per year since 1990. This annual growth rate is expected to continue over the next decade. A quick perusal of the job opportunities at many biotechnology companies, contract manufacturing organizations and staffing/recruiting websites reveals that biomanufacturing jobs are plentiful. The degree requirements for these jobs range from a high school diploma through a Ph.D degree, with the majority of positions being filled by individuals with either associate or bachelor degrees. A recent report issued by Boston-based Education Development Center, Inc. indicated that the majority of new biomanufacturing jobs will be for technical personnel in the following areas:
  1. QC chemistry
  2. QC microbiology
  3. environmental health and safety
  4. facilities maintenance
  5. instrumentation/calibration
  6. manufacturing (upstream)
  7. manufacturing (downstream)
  8. process development
  9. QA documentation
  10. validation
  11. aseptic processing (fill/finish)
Good Hunting!!!!!!!! --------
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Posted on March 19, 2006 by BioJobBlogger

Regulatory Compliance Training

I taught a class this weekend at Georgetown University Medical School called Regulatory Compliance In Biopharmaceutical Drug Development and Biomanufacturing. I had about 30 students in the class who sacrificed their weekend to listent to me! The students who signed up for the class are all working on a Master of Biotechnology degree. The Georgetown Biotechnology program was started in the mid 1990s by Jack Chirikjian and boasts an annual enrollment of about 60 students. Many of these students find biotechnology jobs upon completion of the program. If you are contemplating a career in the pharmaceutical or biopharmaceutical industries, I highly recommend that you take a course similar to this one. One of the main things that current employers are looking for in job candidates is an understanding of the government regulations that guide drug development in the private sector. If you do not know what I am talking about, you better take a regulatory affairs course before you send out that first resume. Mentioning a few buzz words like GLP, GMP, IND, or NDA (and actually being able to discuss them) will certainly impress any hiring manager that I know. Remember, knowledge is power (as somebody famous once said)!
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Posted on March 10, 2006 by BioJobBlogger

Medical Writing: Not a Bad Option!

As part of my quest to do as many things that I can during the course of my professional career, I recently took a contract position as a medical writer. After three days on the job, I think that I may finally be on to something big. I mean, what other job will pay you between $50-$150 per hour to sit in front of a computer all day and write things? It can be a dream job for anyone who has spent any time in academia. If you figure it takes about 200 hours (about a month) to put together a grant application; @ $50 per hour, the minimum amount of money that you could expect to receive from grant writing would be about $10,000 per grant! When you can factor in all of the hours spent on manuscript preparation (especially during that push for tenure), then there is some serious money to be made. I think, that, by now, you are getting my point. But, I can honestly say that the best thing about medical writing is that there is almost no emotional relationship between the writer and what is being written. That is because, as a medical writer, you are typically writing a manuscript or publication for a physician(s) who does not want to or have the time to write ithemselves. In this regard, you are nothing more than a hired gun or more aptly, a ghost writer. I guess after it is all said and done, many physicians REALLY DO have it easier than most Ph.D.s. But, having someone else write your papers? Surely, not we Ph.Ds!!!!!! --------
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Posted on March 3, 2006 by BioJobBlogger

Why Is GLP Training in Such High Demand?

Several years ago Good Manufacturing Practices (GMPs) were all the rage. Now, it seems that Good Laboratory Practices (GLP) have replaced GMPs. For those of you who do not know what GLP is, it refers to the regulatory guidelines that must be followed while conducting toxicology experiements on preclinical drug candidates. If preclinical toxicology experiments are not performed in a GLP-compliant fashion, regulatory agencies like FDA and EMEA will not review drug applications , e.g. INDs, for drug candidates. GLP guidelines, like GMP regulations , represent the minimum regulatory requirements that must be met in order for regulatory agencies to ensure that a particular drug is safe and efficacious. Company employees or executives who do not have a firm grasp of GLP rules and regulations should seek out GLP training ASAP. One company that offers GLP training is BioInsights, Inc. (www.bioinsights.com). Better to be SAFE than sorry! --------
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