Senior QC Associate

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. 

We’re 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 work-life 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: https://www.sarepta.com/join-us
 

The Importance of the Role

This individual will support quality control activities including management of a centralized program governing reference standards and critical reagents used across a wide network of QC labs in the testing and release of clinical and commercial products. This individual will also support assay lifecycle processes, such as method optimization, qualification/validation and tech transfer activities.

The work involves generation and qualification of critical reagents, maintaining inventory, and stability related tasks to support AAV and siRNA-based product testing at the Andover Sarepta site and at contract labs. The individual will conduct laboratory support processes such as maintaining cell cultures, generating and analyzing data, and maintaining GMP records.
In addition, the individual will contribute to assay optimization and qualification/validation activities for cell and molecular biology assays being conducted internally at Sarepta Andover as well as tech transfers to external partners as SME for analytical methods.

The individual will support the team manager 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 position is onsite 5 days a week.

The Opportunity to Make a Difference

• Lead the lab activities associated with the qualification and maintenance of critical reagents and reference material.
• Work requires performance of assays in a GMP BSL-2 environment.
• Train and become qualified to perform additional assay work, as needed, to support future pipelines.
• Design, screen, and document PCR primer/probes to be used in qualification of viral vectors as needed.
• Support analytical methods through assay optimization and contribute to method qualification and validation activities.
• Support continuous process improvement initiatives through optimizations and assay robustness improvements such as introduction of automation tools.
• Represent Sarepta to external partners, assisting with tech transfers and review requests as needed.
• Support analytical trending through compilation and analysis of data related to critical reagents and reference materials.
• Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
• Support troubleshooting activities as a SME for Laboratory Investigations and deviations.
• Create and maintain clear and concise records and documentation.
• Assist in writing and reviewing quality documents such as SOP, CAPA and Change Control originated internally as well as at the vendor sites.
• Perform other related duties incidental to the work described.

More about You

• B.S. degree in a scientific discipline with at least 5-8 years relevant experience (B.S.) or a M.S. with at least 2-5 years relevant experience.  
• Working experience in a cGMP environment is required.
• A strong understanding of cell culture methods, Jess/Capillary electrophoresis western blotting,  polymerase chain reaction (PCR), agarose gel electrophoresis, SDS-PAGE, ELISA, and spectrophotometric assays is required.
• A familiarity with regulatory (FDA, EU, etc.) and compendial (USP, EP, etc.) guidance is highly desired. 
• Hands on experience running protein-based immunoassays and/or qPCR/ddPCR assays.
• Experience in developing, validating, optimization and deploying cell and molecular biology test methods is highly desired.
• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary.
• Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
• Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
• Must have effective written and verbal communication skills. 
• Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency. 

What Now?

We’re always looking for solution-oriented, critical thinkers.

So, if you’re 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.
 

#LI-Onsite

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

The targeted salary range for this position is $94,800 - $118,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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.

Develops precision genetic medicines for rare diseases.