QC Associate Biochemist

Basic qualifications:

B.S. degree in a science field required

Willing to work on call and able to respond with 60 min

A maximum of 36 months experience- given that this position is entry level.

Preferred qualifications:

  • Ability to work both individually and as part of a team with very good communication skills (verbal and written).
  • Strong organizational skills.
  • Ability to learn new methods and analyze data, including trends.


The Associate Biochemist performs stability sampling, testing, and data review for biopharmaceutical drug substance and drug products (clinical and commercial).

  • Performs stability inventory management, which includes sample coordination, aliquoting for routine testing, coordinating sample shipments, performing sample inspections, performing aseptic bulk stability fills, and performing annual inventory inspections.
  • Performs routine compendial testing on stability samples per SOP and GMP (visual inspection, pH, osmolality, residual moisture, subvisible particulate matter, container closure integrity).
  • Performs laboratory duties following all safety, cGMP, CFR and other regulations in order to assure laboratory compliance.
  • Performs routine laboratory duties and safety checks to ensure compliance, as assigned.
  • Performs stability data verification for use in stability reports, and responsible for updating stability data tables and trends, as required.
  • Utilizes LIMS in daily laboratory and stability operations.
  • Operates and maintains QC laboratory equipment/instrument per GMP, including responsibilities for installing / deactivating equipment/ instrument per GMP procedures, as assigned.
  • Participates in the on-call response team for chamber excursions, as assigned.
  • Assists in compendia methods and other analytical method qualification/validation/transfer as assigned. Writes protocols and reports as assigned.

Contact information:

You may apply for this position online by selecting the Apply now button.

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