Manager Gene Therapy Quality Control
Manager Gene Therapy Quality Control
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Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
This individual will support Quality Control (QC) activities conducted both at the Contract Test Laboratories (CTLs) and internally for molecular biology and biochemical analyses. This position involves managing up to three direct reports. The individual will be responsible for supporting test method transfer and technical interpretation of data supporting release of AAV gene therapy products. Oversight of chemical and biological test methods including but not limited to: Sanger sequencing Polymerase Chain Reaction (PCR) (qPCR ddPCR) molecular cloning Western blotting Bicinchoninic Acid Assay (BCA) SDSPAGE protein purification Endotoxin ELISA virus purification Analytical Ultracentrifugation (AUC) capillary electrophoresis and other cellbased test methods. The individual will be responsible for reviewing release data writing technical reports supporting analytical method transfer activities conducted at the 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. This job requires exceptional organizational skills and excellent communication skills as well as the ability to balance changing priorities and tight timelines.The Opportunity to Make a Difference
- Manage release testing of commercial and clinical products at contract testing laboratories.
- Review gene therapy product release and stability data generated at the CTLs and Sarepta.
- Generate product release Certificate of Analysis (CoA) and associated GMP documentation.
- Manage QC lot release metrics and support lot disposition.
- Collaborate with cross functional teams to establish project timelines and priorities ensure QC deliverables and timelines are met.
- Author and review Quality documents such as SOP OOS/OOT CAPA and Change Control originated internally as well as at the vendor sites.
- Manage up to three direct reports.
- Support the method transfer and qualification/validation activities associated with the release of bacterial plasmids cell banks and viral vector drug products.
- Support CMC regulatory functions.
- Trend data for qualified materials release products and stability products.
- Review scientific literature for incorporation into technical reports and laboratory investigations.
More about You
- BS degree in a scientific discipline with 58 years of related experience. MA/MS degree with 4 years of related experience preferred.
- Working experience in a cGMP environment is required.
- Understanding of PCR methods ELISA Capillary Electrophoresis SDSPAGE Western blotting Sanger Sequencing and cellbased assays is necessary.
- Experience in virus amplification and purification is desirable.
- Experience in developing validating and deploying molecular biology test methods is useful.
- Proven ability to work independently and effectively handle multiple priorities is a must.
- Must have effective written and verbal communication skills.
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Manager
Employment Type
Full-Time
