Tandym Group
Senior Analyst I, Quality Control Chemistry
Location: near Boston, MA. Qualified Candidates must be able to work on a W2 basis.
Base pay range $47.00/hr - $47.00/hr
Overview Our client, a recognized pharma company, is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract near Boston, MA.
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)
Seniority level Entry level
Employment type Contract
Job function Manufacturing
Industries Pharmaceutical Manufacturing
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Base pay range $47.00/hr - $47.00/hr
Overview Our client, a recognized pharma company, is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract near Boston, MA.
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)
Seniority level Entry level
Employment type Contract
Job function Manufacturing
Industries Pharmaceutical Manufacturing
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