A recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA. In this role, the Senior Analyst will specifically support the gene therapy program pipeline, including technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability.
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
Desired Skills:
- Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS
- Experience working with external contract labs (CMOs, CROs)
