Associate Director, QC Cell Culture and Bioassay
Location
Andover, MA | United States
Job description
The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline. The Associate Director will build and oversee a team of eight to ten QC technicians 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. The AD will work with QC Data Management and QC-Operations teams to guarantee the timely delivery and authorization of test data as well as to ensure that the lab is maintained in a state of inspection readiness, operating on a seven day/week continuous testing schedule. The AD-QC Cell Culture and Bioassays will work cross-functionally with members of the Analytical Development and QC-Technical Services (QC-TS) teams to develop, transfer, and qualify phase appropriate assays in support of the Sarepta Gene Therapy pipeline.
Primary Responsibilities: - Provide technical leadership and subject matter expertise to the cell culture and bioassay team to ensure the successful execution of all GMP release and stability bioassays executed in support of Sarepta' s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs).
- Develop and manage a team of eight to ten Quality Control technicians, with a strong emphasis on training and right-first-time performance.
- Schedule testing to ensure the timely delivery of data to support continuous product supply - will be required to maintain a continuous 7 day/week testing schedule, inclusive of holidays.
- Track and trend all cell culture and bioassay test data and reference standard performance data.
- Identify OOS, OOT, invalid, and unexpected test results, institute swift, thorough, and compliant investigations to identify root cause and implement appropriate corrective actions.
- Resolve/close all Quality Events (deviations, CAPAs, investigations, change controls, etc.) promptly and on-time.
- Maintain the laboratory in a compliant GMP-inspection ready state at all times.
- Establish cross-functional relationships with Sarepta Analytical Development and Quality Control-Technical Services (QC-TS) teams to ensure bioassays introduced to QC are compliant and sufficiently robust.
- Work Cross functionally with Sarepta QC-TS to develop and maintain a two-tiered reference standard for the SRP-9001 commercial GT product, work with QC-TS to develop phase appropriate reference standards for clinical pipeline products.
- Work with Sarepta QC-TS to draft and execute internal tech transfers, method qualification, and method validation protocols.
- Work with Sarepta Quality assurance to draft and approve method, reference standard, qualification and validation reports.
- Support all regulatory submission and address health authority questions for all IND, INDa, BLA, and NDA approvals.
- Provide technical support to CTLs and CDMOs as needed.
Desired Education and Skills: - BA/BS degree in a related field with 10+ years related experience, or MA/MS degree in a related field with 8+ years related experience, or AA/AS degree in a related field with 12+ years related experience
- Five to eight 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 is required.
- Experience with various molecular biology assays (immuo-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.
- Solid understanding and hands-on experience applying basic statistical tools for data analysis and trending.
- A solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to bioassay execution and method qualification/validation is necessary.
- Attention to detail with exceptional and demonstrable record keeping / documentation skills.
- Extensive technical writing skills. Experience drafting GMP SOPs, protocols and reports.
- Project management skills including the ability to manage one's project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
- Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
#LI-Onsite
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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