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Senior Gene Therapy Quality Control Specialist
4 weeks ago
The Senior Gene Therapy Quality Control Specialist will play a key role in supporting and maintaining 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.
This position 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 ideal candidate will have a strong technical background and proven track record in Quality Control with methods related to cell biology, biochemistry, and molecular biology.
Key Responsibilities
* Collaborate internally and externally 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.
Requirements
* 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.
* 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.
About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on the development and commercialization of innovative therapies to treat rare neuromuscular diseases. We are committed to delivering life-changing treatments to patients and families affected by these devastating diseases.
