Gene Therapy Quality Control Specialist

4 weeks ago


Andover, Minnesota, United States Sarepta Therapeutics Full time
About the Role

The Manager, Gene Therapy Quality Control Critical Reagents will play a critical 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 role will also be responsible for working with other team managers to help with the selection of reference standard lots and/or identification of critical reagents.

Additionally, the individual will assist in generating certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), and oversight of CTLs.

This position will also involve managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending, all while working in a GMP compliant manner.

About the Opportunity

This is an exciting opportunity to collaborate internally and externally (Contract Testing Labs and Contract Manufacturing Organizations) to manage the lifecycle and monitoring of critical reagents and reference standards integrated inventory related to gene therapy test methods for in-process, release, and stability testing.

The individual will be responsible for selecting vendors, procurement, tracking, and trending critical reagents and reference standard performance.

This position will also support cGMP operations, including technical review of change control documentation and reports, deviations, OOS, and other investigations.

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.

Experience managing direct reports and developing next-level leaders is also highly desirable.

This position requires a strong understanding of cGMP/ICH/FDA/EU regulations and experience with statistical software packages such as JMP for trending applications.

About You

We are seeking a highly motivated and experienced professional with a B.S. or M.S. in molecular biology, cell biology, virology, or a related field.

The ideal candidate will have at least 7+ years of relevant experience in QC GMP environment in a clinical and/or commercial setting, with commercial experience being a strong plus.

The individual should have 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 is also highly desirable.

This position requires a strong understanding of cGMP/ICH/FDA/EU regulations and experience with statistical software packages such as JMP for trending applications.



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