Primary Responsibilities Include:

• Review gene therapy product release and stability data generated internally at Sarepta.
• Generate product release Certificate of Testing (CoT) and associated GMP documentation.
• Author and review Quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
• Support review of test methods, development reports, study protocols, and validation reports data and reports.
• Trend data for qualified materials, release products, and stability products
• Review scientific literature for incorporation into technical reports and laboratory investigations.
• Experience in general laboratory experimentation and the use of electronic notebooks.
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), familiarity with cGMP quality systems - Veeva, LIMS.
• Perform other related duties incidental to the work described.
• Manage up to six direct reports.

Desired Education and Skills:

• BS degree in a scientific discipline with 5-8 years of related experience. MA/MS degree with 4+ years of related experience preferred.
• Working experience in a cGMP environment is preferred.
• Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
• Understanding of relative potency assays, infectious titer assays, and replication competent vector assays is highly desired.
• An understanding of PCR, qPCR, ddPCR, and DNA sequencing (Sanger and NGS) is highly desired.
• An understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to bioassays, nucleic acids data review and method qualification/validation is necessary.
• Attention to detail with exceptional and demonstrable record keeping / documentation skills.
• Project management skills including the ability to manage one's project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• 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.
• Extensive technical writing skills. Experience drafting GMP SOPs, protocols and reports.
• Operate as a part of a team with experience supervising and or training individuals in a functional, safe working environment while maximizing efficiency.

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

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.