Quality Assurance (QA) Manager (Senior Manager, DOE)

AffyImmune Therapeutics, a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Quality Control professional to help advance the use of CAR T cell therapy for solid tumors.

Reporting to the Vice President of Quality, you will join a small team at a dynamic startup. You will directly oversee activities at contract QC laboratories, perform data analysis, support investigations, change controls, deviations, and corrective/preventive actions.  You will also collaborate with internal Analytical Development on method transfers, qualification, and validation. Other key internal interfaces are Process Development, Manufacturing, and Quality Assurance.

Location: Natick, Massachusetts; or Remote.

Responsibilities:

Quality Control Operations (85%)

  • Oversee QC testing at multiple contract laboratories; participate in day-to-day troubleshooting, OOS/OOT investigations, CAPA identification, implementation, and follow up.
  • Coordinate QC sample management and logistics to enable testing at multiple contract laboratories.
  • Review analytical data packages, assemble test results from multiple laboratories. 
  • Perform data trending and analysis, report unexpected trends to management.
  • Monitor stability programs, timely data generation and analysis to support shelf-life assignment.
  • Monitor contract laboratory operations to ensure compliance with Regulations & AffyImmune Quality Standards
  • Partner with Analytical Development on method transfers and implementation of method optimizations.

Quality Control System Build (15%)

  • Monitor QC vendor performance metrics and periodically report findings to management.
  • Participate in contract QC laboratories qualification audits.

Qualifications:

  • BS/MS in Bioanalytical Sciences with experience in cell therapy or related fields. In-depth knowledge of relevant technologies including Flow Cytometry, qPCR, ddPCR/dPCR, cell culture, sterility, and biological potency.
  • Minimum 3-5 years of hands-on QC laboratory experience: routine testing, reference standards and reagents management, instrument calibration/maintenance.
  • Demonstrated experience overseeing contract QC testing organizations.
  • Excellent understanding of ICH and FDA regulations and guidelines for Quality Control processes.
  • Significant time-management skills to ensure timely issuance of drug product CoA’s.
  • Comfort with Microsoft Office (PowerPoint, Excel, Word) and electronic document management systems.
  • Able to interpret, summarize, and discern criticality of issues for escalation.
  • Strong work ethic, enthusiasm, eagerness to learn, and willingness to perform ad-hoc tasks.
  • Excellent written and verbal communication with meticulous attention to detail.

This is a salaried, benefits-eligible position.

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