QC Analyst I
This is a 12-month contract through Randstad at Takeda Pharmaceuticals in Lexington, MA.
Job Summary/Operations Involvement:
- Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations.
- Testing may include but not limited to samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods.
- This position is expected to maintain operational and GMP readiness of the QC areas.
Specific QC Focus Area:
- Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Activity assays, DNA, PCR, Free Thiol
- HPLC focus: techniques such as SEC-HPLC, RP-HPLC, IEX, CE-SDS, iCE, enzyme activity, glycan mapping and peptide mapping
Education and Experience:
- Essential: Bachelors degree and minimum of 0-2 years related experience
- Desired: GMP knowledge, work experience
- Knowledge: Limited use and/or application of basic principles, theories and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
- Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding