QC Molecular Biology Manager

4 days left

Homology Medicines, Inc.
Bedford, Massachusetts, US
Apr 28, 2021
May 10, 2021
Employment Type
Full time
Salary Type
The HMI Quality Control Molecular Biology Manager is responsible for the quality control support of a new clinical phase I/II GMP manufacturing facility. The leader will manage the QC team that will perform ddPCR, qPCR, and cell-based testing in support of: in-process, drug substance, and drug product release, stability, vector production, and method qualifications. We seek candidates with a proven ability to work independently and collaboratively to achieve optimized strategies, and to execute programs with the ultimate goal of delivering products that transform the lives of our patients.

  • Manage the QC molecular biology team including staff, departmental goals, and corporate goals/culture.
  • Oversee operations of the internal QC lab molecular biology testing supporting manufacturing, release, stability, and vector product testing.
  • Oversee and provide SME guidance for method transfer, qualification and validation activities for ddPCR, qPCR, and cell based assays.
  • Draft test methods, SOPs, protocols, and reports as needed.
  • Review data, write and lead QC investigations, write deviations and CAPAs, and perform risk assessments as needed.
  • Train and coach staff and support scheduling of day-to-day lab operations.
  • Support regulatory filings and CMC teams as needed.
  • Provide SME support for external manufacturing operations as needed.
  • Ensure timely product disposition.
  • Partner with cross-functional teams to ensure successful delivery of key milestones.

  • Bachelor's degree in chemistry, biology, microbiology or equivalent. Advanced or doctorate degree in a scientific discipline preferred.
  • Minimum of 5 years of experience in the pharmaceutical/biotech industry.
  • Subject matter expertise in ddPCR, qPCR and cell-based assays.
  • Prior experience in method qualification, method transfers, validation, quality control execution and laboratory investigations.
  • Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
  • Comprehensive knowledge of quality principles and GMP, ICH and GLP regulations.
  • Ability to prioritize activities, coach, and guide team members effectively, and to deal with multiple parallel competing activities is a must.
  • Strong interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and with regulatory authorities.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.

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