This individual will support quality control activities related to custom raw material manufacture for RNA and AAV gene therapy products conducted both internally and at various contract manufacturing organization (CMO) sites.

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 CMOs.

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.

Primary Responsibilities Include :

• Performing routine and non-routine analytical tests of custom raw material per cGMP for release and stability samples using HPLC, GC, KF and other general laboratory techniques.
• Review raw data, protocols, reports, and CoA / CoTs for release and stability of RNA based products (HPLC, GC, KF) and AAV based gene therapy products (e.

g. qPCR, ELISA, SDS-PAGE, Sanger sequencing, UV spectrophotometry) generated internally as well as at the vendor sites.

• Create and maintain clear and concise lab records and documentation.
• Monitor, review and trend stability data.
• Assist in writing and reviewing quality documents such as test methods, SOP, change controls, and investigations originated internally as well as at the vendor sites.
• Support method transfer and qualification / validation activities associated with the release of raw materials for RNA and AAV platforms.
• Perform other related duties incidental to the work described.

Desired Education and Skills :

• MS with 1-2 years or BS with 2-4 years in Chemistry or related science field. With appropriate experience this requirement may be waived
• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary.
• Must have attention to details and strong organizational skills.
• 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.

LI-Onsite

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

The targeted salary range for this position is $72,000 - $90,000 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.

Last updated : 2024-05-19