Our client, a recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA.
Qualified Candidates must be able to work on a W2 basis.
Responsibilities:
- Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
- Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
- Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
- Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed
- Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods
- Perform other duties, as needed
Qualifications:
- 5+ years of experience working in c GMP environment
- Bachelor’s and/or Master’s Degree Analytical Chemistry, Biochemistry, Biophysics, or a related discipline
- Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry
- Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is a plus.
- Experience working with external contract labs (CMOs, CROs)
