QC Stability Coordinator

Job Locations US-MA-Lexington
Job ID


Responsible for the maintenance and development of the stability program at Agenus, Lexington.  Coordinate the stability studies of drug substance and drug product in accordance with GMP and ICH guidelines. This role involves interaction with in-house and contract laboratories.  Responsible for analyzing common analytical data such as: HPLC, A280, ELISA and Microbiological methods.  This role will also support in-house QC activities and management of QC testing at external labs.


  • Oversee the vaccine stability program for Agenus including protocol and report generation for drug substance, drug product shelf life and other special studies.
  • Review analytical results from internal and external testing labs for compliance to specifications and reports abnormalities.  Resolve any testing or documentation issues with contract testing labs.  Evaluate the stability data for trends.
  • Manage stability samples inventory, reference standards, and retains. Manage the distribution of stability samples for testing. Coordinate outside contract testing as needed.
  • Investigate and generate reports on deviations and any non-conformance in accordance with QC procedure.
  • Determine stability sample requirements, develop and review stability protocols in accordance with ICH and regulatory requirements. 
  • Monitor and review control charts of the stability chambers to confirm environmental conditions operating within acceptance tolerances.  Collaborate with Validation, QA and other functional SMEs to qualify equipment used to support stability including controlled temperature units and stability software.
  • Prepare interim and final reports for FDA submissions, Annual Product Review and Annual Product Report.
  • Interact with internal and external auditors as the subject matter expert.
  • Support QC laboratory, as needed.  General laboratory support, including but not limited to, sample receipt, inventory control, reagent preparation and equipment and instrument maintenance.
  • Participate on project teams.


  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Strong knowledge of bio-analytical techniques for proteins and other biologic products
  • 5+ years relevant experience in QC / GMP.  Minimum of 1-year stability coordinator experience
  • Knowledge of ICH Q1A-F and Q5C guidance documents
  • Experience with stability software is a plus
  • Experience with regulatory requirements and audits
  • Detail oriented with strong written and verbal communication skills
  • Ability to work independently, within prescribed guidelines, or as a team member


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