QC Molecular Biology Manager
4 days left
- 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.