Wednesday, August 14, 2013

Ask CJ: no GMP experience? / PI's presentations on your CV?

Two good questions I've been meaning to get to:
I have recently been looking at jobs in the [Mid-Atlantic] area and for the most part I seem to meet the qualifications they post - except for experience with cGMP. I'm at a loss for how I would find a job to even get my foot in the door, so to speak. Is not having experience with cGMP as big of a deal as I think it is, or do you think that companies would be somewhat lenient as long as I was willing to learn?
CJ sez: cGMP is not only a weird set of amorphous regulations emanating from Q7A; it's also a bit of a mindset. It is hard to get that training anywhere than on-the-job, so I can understand why some companies wish other companies would train their people well, so that they could poach them.

Couldn't hurt to apply, but don't expect an enthusiastic response.

Also, a reader asks a very creative question about adding lines to your CV:
I've only given one presentation of my own work outside my department, but my PI has presented my work at a couple of larger conferences (Gordon conferences etc.). Is it appropriate to list those presentations in a separate section of my CV indicating that it was my work but I did not do the actual presenting? Or should it just be left off all together?
CJ sez: No dice. While I think that giving data that ends up in a presentation should give you some kind of co-credit, I don't think that's standard practice in chemistry. (That said, I think that you could probably get away with it if you were apply to non-chemistry jobs.)

Readers, you're smarter than me -- what do you think? 


  1. CJ,

    I agree with both your replies, although I have found that the "mindset" of cGMP varies from company to company. Making bandages is totally different than heart-and-lung machines, and so is the devotion to cGMP. As it should be. Taking someone out of the latter and putting them in former would require them to dial back on the rigidity somewhat.

  2. I'm at my 3rd GMP shop; got the first job straight out of school with no experience, but was trained on-the-job in them. Both subsequent companies have put me through extensive training in GMP, 21CFR, etc etc etc. The mindset seems to be they can't trust anyone else to have adequately trained you, and since you're probably not transferring your training records to your new job, they have no proof in their systems beyond your CV that you know them, so do it all fresh.

    By which I mean it doesn't matter if you've done it before, you'll be doing it again when you start somewhere new. And if you've never done it before, prepare yourself for one of the most thrilling experiences of your life.

    As to whether the candidate needs GMP experience, it's all dependent on the position to which they applied. If they're hoping to come in as QC lab manager, no chance in hell. If they're entry-level synthetic / formulation / analytical type person, it's less important. When I'm considering candidates, their GMP credentials fall pretty damn far down the list.

    1. You might have GMP further down your list when looking through credentials, but the HR folks filtering resumes most certainly use it up front to cull the herd of applicants. Filtering by acronym is what most non-technical reps do.

      I recently got a new (non-GMP) job and my new boss mentioned that he had to explain how he got my resume since mine had "scored" so poorly in HR's screening software. Supposedly they are using his feedback to tweak the algorithm...right.

    2. Good point; I guess if you're up against a brainless screening process (computer or human), it's a smart move to find a way to get the desired keywords into your resume, rather than get culled unnecessarily.

      For example, do a bit of reading on GMP (FDA guidances, wiki, the other top 5 things that come up on a google search). Congrats, you're now "Familiar with cGMP." You're not saying you've worked under them, or been officially trained, but it's a line on your resume that might help you get it to a hiring manager.

  3. Depending on nature and level of positions it could mean seeking some one who has familiarity of basic concepts more than significant hands on in specific function. In certain cases taking a course/seminar might be a good starter to express tangible "willingness to learn", there are many offering (DIA, PDA) and many categories (API, DP) so need to narrow down target. cGMP training is probably something better learned in real world experience, and as noted companies can operate differently in interpretations in that context getting someone from the outside may not be good fit (however would argue at higher levels in QA/Reg having people with more diverse exposure is critical to avoid trap of in-house mentality that may be in error or not optimal).

    If a person who did the work is listed on a poster or a presentation then it is legitimate to note on CV (as contributing author credit) which clear indication who gave actual presentation, especially if can further indicate preparation of a publication is in progress or planned

  4. If it helps your CV, why not list the talks others have given with your data as a distinct subsection? "Presentations based primarily on my data:" probably would be a good title, and you could explicitly list the presenters if it wasn't you. This as long as you had one or two of your own talks in a different section, and as long as the title of the talk made it clear that it really was primarily related to your data, as described elsewhere on the CV.

    Like this:

    Invited Presentations:
    - Oral presentations:
    - "Research on topic XYZ: breakthroughs I have made". Departmental Seminar at University of Learning. Given 1 January 2010.
    - "Understanding XYZ: new revelations from studying ABC." ACS National meeting. Given 1 January 2011.
    - etc.
    - Poster Presentations:
    - "Understanding XYZ by looking for bimolecular interactions between X and Y". ACS regional meeting poster session. Given 1 January 2009.
    - etc.
    - Presentations based primarily on my data:
    - "Work on XYZ unfolding in my lab". Gordon conference on Research in late-alphabet characters. Given by Prof. Famous on 1 January 2011.
    - "XYZ: does the binding of X to Y occur before the binding of Y to Z? a mechanistic study" International conference on late-alphabet characters. Given by Prof. Famous on 1 January 2012.

  5. In response to the first question, don't do it. I worked in a cGMP lab for a while, and I could feel my brain turning into pudding - we were expected to just follow the method and not think or ask questions. A robot could have done my job. I got out with my dignity semi-intact after less than a year.

  6. I manage a GMP lab. The mantra that it is "a rumor unless it is written down" applies very well. I prefer to hire right out of school or with GMP experience. I found that the longer a person worked in a non-regulated environment, the harder it is to get them to work in a compliant manner. I have had employees be outright hostile about it. This is not Groton, CT. This is real life. Since I have had to sit across from an FDA inspector and explain why my analyst screwed up and what I was going to do about it, I am not interested in employees who can't or won't take GMPs seriously.

    1. Thanks for sharing your knowledge, Anon.

  7. I work with a number of people who do the hiring in cGMP facilities. They specify number of years experience in a cGMP setting and doing X, Y, or Z job so that they can see that you don't have the academic mindset many fresh graduates or post-docs do. We all know grad students and post-docs that spent years purifying one protein or compound, etc. In a cGMP setting they're looking for people who can successfully do this on a manufacturing scale and are product-driven.

    There are universities out there now offering masters degrees in GMP/GLP and such under headings like Masters of Biotechnology or something similar. These are non-thesis 1-2 year programs that teach basic protocols in addition to business admin. More and more of the companies I work with hire directly from those programs.

    Additionally some pharma companies are offering post-doc fellowships with on the job training. They pay better than academic post-docs but often involve a heck of a lot of moving around the country and world while rotating through different facilities. The companies then hire direct from their talent pool.