In Vitro Potency Associate

This individual will support quality control laboratory activities conducted at Sarepta Andover facility in the field of AAV therapeutic release and stability. The individual will assist in conducting GMP QC release and stability testing using state of art In vitro Potency Assay. The candidate should have hands on experience of SDS-PAGE, Western blotting, enzyme activity measurements, protein extraction and quantification methods. The position requires a background in cell culture, tissue lysate sample preparation, protein analysis and performing assays in a BSL-2 environment. The individual will work under the direction of a subject matter expert conducting experiments and support analytical method validation and qualification activities. All aspects of this position involve working in a GMP compliant manner.

• Perform In Vitro Potency assay in support of release and stability testing of AAV based gene therapy products.

• Support Preparation, qualification, and release standards for the In Vitro Potency methods.

• Test new cell lines for use in new potency assays

• Maintain cell banks in cryogenic storage

• Create and maintain clear and concise lab records and documentation.

• Support the method development, transfer and qualification/validation activities

• Perform other related duties incidental to the work described.

Desired Education and Skills:

• B.S. degree in molecular biology, cell biology or virology with 0 - 2-years ' relevant experience.
• Working experience in a cGMP environment would be desired.
• A good understanding of cell culture methods, SDS-PAGE, Western blotting, enzyme activity measurements, protein extraction and quantification methods, and cell banking is necessary.
• Experience in general laboratory experimentation and documentation is necessary.
• Experience in developing, validating, and deploying molecular biology test methods is useful.
• Must have effective written and verbal communication skills
• Operate as part of a team, assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency

This position requires work on site at one of Sarepta’s facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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.