Senior Analyst I, Quality Control Chemistry (Woburn)Tandym Group • Woburn, MA, United States

Senior Analyst I, Quality Control Chemistry (Woburn)

Tandym Group • Woburn, MA, United States

3 days ago

Job type

Full-time

Job description

A recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA.

This position is for candidates who are 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 cGMP environment

Bachelor's and / or Master's Degree in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline

Experience working in the cGMP QC lab of the Pharmaceutical or Biopharmaceutical industry

Experience working with external contract labs (CMOs, CROs)

Desired Skills :

Experience analyzing Nucleic Acids, Virus Capsids, Antibodies, and / or other Biologics materials using HPLC / UPLC, LCMS, AUC, UV- Vis, CE-SDS

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Quality Control Analyst • Woburn, MA, United States

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