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Lab Manager – Quality Control – Friday-Monday Shift
| Company | Sarepta |
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| Location | Andover, MA, USA |
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| Salary | $112000 – $140000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- B.S. degree in Biology or Biochemistry with course work emphasizing analytical molecular biology techniques. Additional training in cell biology is a plus.
- A minimum of five years of relevant experience in a regulated GMP environment is necessary. Experience working with gene therapy products is highly desired.
- Two to four years of experience building, developing, and managing GMP Quality Control testing teams is required.
- Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
- A strong understanding and practical experience with aseptic cell culture (mammalian, insect, and bacterial cell lines) is required.
- A strong understanding and practical experience with relative potency assays, infectious titer assays, and replication competent vector assays are required.
- Experience with various molecular biology assays (immuno-assays, ELISA, SDS-PAGE, CE-SDS, etc.), classical cell-based virology assays (TCID50, plaque assays, titer reduction assays, neutralization assays etc.) as well as analytical chemistry methodologies and principles is required.
- Experience with general laboratory organization, experimental execution and documentation (GDP), and adherence to cGMP is necessary.
- Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems – Veeva, Theia, LIMS, IDBS.
- Operate as a part of a team with experience supervising and training individuals in a functional, safe working environment while maximizing laboratory efficiency.
Responsibilities
- Overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta’s Gene Therapy pipeline.
- Overseeing a team of 2-4 QC Shift operators with responsibilities that include but are not limited to: aseptic cell culture, relative potency testing, infectious titer testing, and execution of replication competent vector assays.
- Working with QC Data Management and QC-Operations teams to guarantee the timely delivery and authorization of test data.
- Ensuring that the lab is maintained in a state of inspection readiness, operating on a seven day/week continuous testing schedule.
- Authoring/managing deviations, laboratory investigations, data trending, and review of quality documents originating in the QC laboratory.
- Providing technical leadership and subject matter expertise to the cell culture and bioassay team.
- Developing and managing a team of 2-4 Quality Control Operators, with a strong emphasis on training and right-first-time performance.
- Scheduling testing to ensure the timely delivery of data to support continuous product supply.
- Tracking and trending all cell culture and bioassay test data and reference standard performance data.
- Identifying OOS, OOT, invalid, and unexpected test results, instituting swift, thorough, and compliant investigations to identify root cause and implement appropriate corrective actions.
- Resolving/closing all Quality Events (deviations, CAPAs, investigations, change controls, etc.) promptly and on time.
- Maintaining the laboratory in a compliant GMP-inspection ready state at all times.
- Conducting SME review of laboratory data and authorization of final reports.
- Collaborating with managers/QC Directors to optimize a smooth workflow.
- Collaborating cross functionally to identify and resolve issues.
- Performing other related duties incidental to the work described.
Preferred Qualifications
- Experience working with gene therapy products is highly desired.
- Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
