The Sr manager, Drug Product Manufacturing & Operations will be responsible for the technical support, process development and production of drug products at external contract manufacturing organizations for Sarepta's gene therapy-based programs. The candidate will partner with CMOs and internal groups to establish robust technical relationships related to the development and manufacturing of gene therapy drug products. The candidate will be responsible for the development and technology transfer of manufacturing processes, as well as providing day to day support for GMP manufacturing. This position will provide expertise in the areas of process development, validation, aseptic fill/finish, product life cycle management, technology transfer, primary packaging, visual inspection and process analytics.

Primary responsibilities include
- Act as key technical contact for contract manufacturers including, but not limited to providing PIP support, technology transfer and validation support, deviation and change control development and implementation, CAPA management and risk assessments.
- Design, develop, implement and troubleshoot the drug product manufacturing processes
- Effectively influence technical teams, both functional and cross-functional, in dynamic situations
- Effectively serve as drug product manufacturing representative for CMC team structure
- Lead the drug product CMO interactions for the assigned program
- Effectively influence manufacturing partners to meet technical objectives to ensure supply by working with CMOs to deliver on all clinical and commercial drug product requirements through process ownership, trouble shooting, transfer and analysis of robust manufacturing processes
- Author CMC regulatory submission documents for clinical and commercial products
- Be the person in-plant during tech transfer, validation activities and routine production as necessary
- Facilitate sterile fill finish manufacturing, and release of clinical and commercial product
- Monitor GMP compliance by reviewing production batch records and escalating discrepancies to senior management as required
- Institute corrective actions and best practices across all fill/finish CMOs
- Coordinating process development and characterization studies with CMOs, third-party test labs and/or internal teams.
- May require some lab-based activities

Education and Skills Requirements:
- This role requires experience in drug product process development, technology transfer, validation and GMP manufacturing- preferably with viral modalities
- Extensive experience developing and managing technical relationships with external contract manufacturing organizations
- M.S. in chemical/biochemical engineering, pharmaceutical sciences, or organic/physical/analytical chemistry, with 3-5 yrs. experience; or B.S. with 5-8 yrs. experience
- Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively across CMC functional areas
- Strong technical writing skills
- Experience with risk assessments and risk-based decision making
- Experience with regulations and requirements such as cGMP, ICH, USP, JP
- Ability to work in a laboratory setting
- Domestic and international travel required

Candidates must be authorized to work in the U.S.
Sarepta offers a competitive compensation and benefit package
Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify

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