Primary Responsibilities Include:

• Actively participates as a member of the Quality Assurance Ops Team and partners with the technical and analytical team.
• Support Manufacturing and Testing Operations during CMO batch production, ensuring unexpected events are handled compliantly and in a timely manner.
• Review and approve documents including: CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations and OOS in support of product release.
• Data entry of lot release cycle times for metrics generation
• Assist with problems of diverse scope using a high degree of judgement and risk-based decision making.
• Apprise management of critical issues.
• Support a state of continuous inspection readiness.

Desired Education and Skills:

• BS/MS in Biology discipline and 4+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations. Experience in setting up GMP operations and systems in new facility is beneficial.
• Detail oriented and the ability to communicate effectively, proactively, and professionally to clients and members of the management team.
• Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

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.