Senior Analyst I, 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.

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)