Manager, Quality Control (QC) – Gene Therapy
About The Position
The Manager, Quality Control (QC) – Gene Therapy provides technical support for assigned assays used in release and stability testing of Gene Therapy clinical products at external vendors. The role is responsible for raw data review, routine data trending, and timely execution of assigned testing deliverables in support of CMC programs. Decision-making is focused on operational and technical execution within established procedures. The incumbent works cross-functionally with internal and external resources on quality control matters and supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.
Requirements
- Master's degree in Molecular Biology, Virology, Biochemistry, or another related discipline and a minimum of 4 years of QC experience in the pharmaceutical/biotech industry; OR a Bachelor's degree in the same disciplines and a minimum of 6 years of QC experience in the pharmaceutical/biotech industry.
- Prior cGMP experience in a QC laboratory.
- Hands-on working knowledge of several of the following: cell-based assays, qPCR/ddPCR, HPLC, SEC-UPLC, ELISA, CE-SDS, and SDS-PAGE.
- Familiarity with mammalian cell culture.
- Exposure to method validation and/or method transfer activities.
- Familiarity with CRO/CMO interactions.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment with internal and external team members.
- Analytical thinking, excellent problem-solving skills, and ability to adapt to changing priorities and deadlines.
- Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects.
Nice To Haves
- QC laboratory experience supporting biologics or gene therapy products.
- Exposure to statistical tools such as JMP or MiniTab.
Responsibilities
- Oversee and support assigned QC testing and raw data review activities from external vendors in support of IND and ex-US clinical filings.
- Review and approve raw data from validated assays performed at CTOs/CMOs for assigned programs.
- Perform routine stability data entry, trending, and summary reporting.
- Coordinate assigned assay activities at CROs/CMOs, including sample shipments, scheduling, and data receipt.
- Support method transfer and method validation activities under the direction of senior QC staff; may author sections of protocols and reports.
- Author and review SOPs, test methods, and routine QC documentation.
- Support OOS/OOT investigations for assigned assays and document outcomes.
- Contribute content to CMC regulatory sections as assigned.
- Adhere strictly to cGMPs and PTC SOPs.
- Perform other tasks and assignments as needed and specified by management.
Benefits
- Medical plan
- Dental plan
- Vision plan
- Retirement savings plans
- Short- and long-term incentives for eligible employees
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What This Job Offers
Job Type
Full-time
Career Level
Manager
