Recruiting for biotech jobs has a lot of aspects to it, including the different job levels as I wrote about previously, and also including understanding the different departments and specialties. Knowing what each department focuses on, as well as which departments have similar base skillsets, will help you out whether you’re job searching for your next role or looking to hire someone for a position.
Process Development: Create the Product Process
Process development is typically comprised of three major groups including upstream, downstream, and analytical & formulation. The exact name of each group may vary by company, and some small companies may have just one person per group (or even one person for all three!), but the skillsets for each group remain different.
Upstream is concerned with everything having to do with the cells and product production. This includes transfection, clone selection, cell line development, passaging, bioreactor development, and harvest development. Typical deliverables that come out of the upstream group include a final clone, the master cell bank (MCB), and the bioreactor and harvest processes.
Downstream takes over after harvest and handles all of the purification steps. This includes capture chromatography, polishing chromatography, buffer exchange through UFDF, viral safety through viral inactivation and viral filtration, and depth filtration. Typical deliverables that come out of the downstream group include the final purification process, the drug substance, and the viral clearance report.
Analytical and formulation development handles all of the product assays as well as developing and stability testing the final DS formulation. This includes ELISAs, UPLC assays like SEC and IEX, SDS-PAGE or Western blots, rCE or nrCE-SDS, mass spectrometry, and more. Typical deliverables that come out of the analytical group include final product assays and the final DS formulation conditions.
Manufacturing: Execute the Product Process
For simplicity, I’m including quality and MSAT groups under the umbrella of Manufacturing, as that is where they are all focused. Many companies have their Quality groups under their own department, and the exact split between MSAT, Validation, and Manufacturing may also vary by company, but the skillsets involve remain consistent regardless of the exact corporate structure.
Manufacturing Sciences and Technology (MSAT) handles everything between Process Development and the Manufacturing floor. This includes process transfer, batch record drafting, method drafting, equipment sizing and ordering, deviation support, and clinical/commercial GMP support. Typical deliverables that come out of the MSAT group include the master batch records, deviation reports and CAPAs, and GMP run reports.
Validation is concerned with all of the validation studies required for commercial products, along with the studies required for operating the GMP facility. This includes chemical hold stability studies, at-scale resin lifetime studies, line clearance studies, facility cleaning studies, and product cleaning studies. Typical deliverables are regular monitoring/validation reports, new product cleanability reports, and late-stage validation study reports.
Manufacturing is the team that performs GMP manufacturing in the GMP facility. This includes operator training, escorting of visitors through the plant, all unit operations from cell thaw through drug product fill, process sampling, and batch record completion. Typical deliverables that come out of the manufacturing group include the clinical/commercial product and completed batch records.
Quality Control handles all of the testing that goes on in the GMP facility. This includes environment and cleaning validation testing, in-process testing, and final lot release testing of the drug substance. Typical deliverables that come out of the QC group include assay results and lot release documents.
Quality Assurance is responsible for reviewing and final release of documents. This includes review of batch records after each GMP run, review of QC results, and review and input into protocols and reports for late-stage studies performed in process development. Typical deliverables from QA include the released documentation from each GMP lot and signoffs on other groups’ protocols and reports.
Department Transitions: Cross-Pollination is Great!
Just because someone starts in one department, doesn’t mean they can’t move to another one! However, it’s easier to make some transitions than others, so having a good idea which ones are closer in type to each other can help both the recruiter and the job seeker. And of course, knowing the levels of the roles for each group is important as well – an Associate II in AFD is not likely to be the right match for a Senior Associate in QC, because while the base skillsets are similar, the specific experience does still matter.
- The closest match is between Quality Control and Analytical / Formulation Development – both involve assays, with the latter executing them in a GLP environment while the former develops them in a PD environment.
- Some great people get their foot in the door by joining the Manufacturing team and then transferring over to a different department after a few years. Depending on their background and interests, they can be successful moving over to Upstream or Downstream Process Development, MSAT, or Validation.
- The documentation requirements in Quality Assurance can teach skills that are also helpful in MSAT and Validation, and vice-versa.
- Mid to senior range scientists in Upstream or Downstream Process Development can transition into MSAT or Validation successfully, especially if they’ve already worked on a late-stage project that involves protocols, batch records, and reports.
A determined person can make any transition between these departments work if they’re truly interested and driven to do so, but they may need to make only lateral or possibly slight downgrades in the process. However, once they are up to speed in their new role, their experience in the original department will provide a perspective that can be very useful to the new group. Great companies also often offer shadowing or cross-training opportunities, which is a great way for someone to try out a different group to see if they like it and are interested in moving there in the future.
Great candidates shouldn’t be passed over without consideration!
A theme of my writing is simply to remind everyone not to pass over great candidates without consideration, even if their skillset isn’t a perfect match for the new role. Find out why they’re interested in a different role, see how they’ve applied their skills so far and how they want to expand them in the new role, and give them a chance if possible. You just might end up with one of the best employees in your group if you do – and I can speak from personal experience, because I certainly did!