Senior Analyst I, Quality Control Chemistry Job at Tandym Group, Woburn, MA

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  • Tandym Group
  • Woburn, MA

Job Description

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)

Job Tags

Contract work,

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