Senior Analyst , Quality Control Chemistry

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.

This role requires onsite presence Monday through Friday.

• 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

• 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)