Senior Associate Gene Therapy Quality Control
Senior Associate Gene Therapy Quality Control
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$ 92000 - 115000
1 Vacancy
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 activities in the field of AAV therapeutic release and stability conducted both internally at Sarepta Andover facility and at contract vendors such as contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs). The work involves reviewing data gathered from routine testing as well as from validations and qualifications. 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.The Opportunity to Make a Difference
- Review protocols testing reports and CoA/CoTs for release and stability of AAV based gene therapy products (e.g. qPCR ddPCR invitro based assays ELISA SDSPAGE HPLC MS and Western Blot) generated at CTLs/CMOs and internally at Sarepta.
- Act as company liaison with CMOs to coordinate in method development method transfer and release and stability testing across various CMO/CRO sites as needed.
- Monitor compile and review analytical and QC data individually and with team members.
- Assist broader Analytical Development/Quality Control team with coordination of sample pulls set downs and tracking critical reagents.
- Create and maintain clear and concise records and documentation.
- Support the method development transfer and qualification/validation activities associated with the release of bacterial plasmids viral vector products critical reagents and reference material.
- Trend data for qualified materials release products and stability products.
- Assist in writing and reviewing quality documents such as SOP OOS/OOT CAPA and Change Control originated internally as well as at the vendor sites.
- Author and review test methods development reports study protocols and validation reports.
- Perform other related duties incidental to the work described.
More about You
- B.S. or M.S. degree in molecular biology cell biology or virology with at least 58 years relevant experience.
- Working experience in a cGMP environment is preferred.
- A strong understanding of cell culture methods polymerase chain reaction (PCR) agarose gel electrophoresis SDSPAGE electrophoresis ELISA and spectrophotometric assays.
- A familiarity with compendial (USP ICH EP) guidance is highly desired.
- Experience in general laboratory experimentation documentation with adherence to cGMP is necessary.
- Experience in developing validating and deploying molecular biology test methods is useful.
- 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:
Senior IC
Employment Type
Full-Time
