Manager, Gene Therapy Quality Control Critical Reagents

The core function of this role is to support and maintain the centralized program management of reference standards and critical reagents used across a wide network of QC labs in the testing and release of clinical and commercial gene therapy products.
The role is responsible for all activities related to monitoring material consumption rates, material inventory levels, and all qualification/ requalification and stability tasks required to support reference standards and critical reagents supply. The role will be responsible for working with other team managers to help with selection of reference standard lots and/ or identification of critical reagents.
The scope will also include generating certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), and oversight of CTLs. The individual will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner.

Primary Responsibilities Include:

• Collaborate internally and externally (Contract Testing Labs and Contract Manufacturing Organizations) to manage lifecycle and monitoring of critical reagents and reference standards integrated inventory related to gene therapy test methods for in-process, release, and stability testing.
• Responsible for selection of vendors, procurement, tracking and trending critical reagents and reference standard performance.
• Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOS, and other investigations.
• Lead laboratory experiments internally for manufacturing and/ or qualification of critical reagents.
• Lead the review of internal SOPs/ policies to align with industry standards related to analytical method and critical reagent lifecycle.
• Lead the implementation of reference standard program for analytical methods and bioassays.
• Provide support to the department leadership with the implementation of new systems and continuous improvement efforts.
• Participate in the generation of new ideas to create efficiencies and improve processes.
• Assist with regulatory and internal inspections, as needed.
• Manage 2-3 direct reports.

Desired Education and Skills: 

• B.S. or M.S. in molecular biology, cell biology, virology or related field with at least 7+ years relevant experience in QC GMP environment in a clinical and/or commercial setting. Commercial experience is a strong plus.
• A strong technical background and proven track record in Quality Control with methods related to cell biology, biochemistry, and molecular biology.
• Experience managing direct reports and developing next-level leaders.
• Experience authoring policy documents, SOPs, protocols, and reports for qualification, maintenance, and monitoring of QC critical reagents and reference standards.
• Technical knowledge of and experience in cell-based and molecular biology-based assays (Potency assay, cell-based ELISA, qPCR, ddPCR assays).
• Strong understanding of cGMP/ ICH/ FDA/ EU regulations.
• Experience with and good understanding of statistical software packages such as JMP, for trending applications.

This position requires work on site at one of Sarepta’s facilities in the United States.

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.