Senior QC Chemist
INCOG is looking for a Senior Quality Control (QC) Chemist that has a passion for working within a team, a desire to drive Quality processes in a regulated setting and to uphold the integrity of the data generated for clients. The Senior QC Chemist will work closely with the QC Chemistry Manager and the Quality Control Method Transfer Scientists as well as Project Management and Supply Chain to support development, readiness, and routine testing activities for the Quality Control Chemistry laboratory.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.
Job Functions:
- Perform routine and batch related testing on incoming materials, in-process samples, finished product and stability samples as well as support developmental study testing for MSAT.
- Assist Method Transfer group in generating low-complexity and/or compendial method verification protocols and summary reports.
- Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes.
- Participate in and drive laboratory investigations/deviations/ change controls and provide SME support where needed.
- Execute routine laboratory work orders for maintenance and non-critical calibrations.
- Assist in the coordination of training and provide training, when necessary, for fellow QC and Development personnel on instruments and assays when cross-training is needed.
- Review /Approve work performed by coworkers for accuracy and alignment with procedures.
Candidate Requirements:
- Bachelor’s Degree in Science (Chemistry or Biochemistry Preferred).
- At least 4 years of pharma/biopharma industry experience, with at least 3 years of hands-on experience with a GMP/GDP environment/Quality Control testing in a regulated environment.
- Proficiency in operating UHPLC/HPLC, GC, CE, ELISA, icIEF, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements.
- Experience in authoring/performing/driving laboratory investigations to GxP standards.
- Experience performing container closure integrity testing (CCIT), and testing/ characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products is preferred but is not essential.
Why INCOG?
- Paid time off, based on tenure & 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
