Associate Director, External Manufacturing at Sarepta Therapeutics in Burlington, Massachusetts

Job Description:

The Associate Director External Manufacturing will report to the Head of Manufacturing and will be responsible for oversight and program management of bulk drug substance operations (make, assess and release) at our partner CMOs. This includes performance management and assurance that contractual obligations are met.

The Position:

This position will report to the Director of Manufacturing and will be responsible for oversight and program management of operations (make, assess and release), in addition to management of contract/ invoice management (cost and budget). This includes ensuring clinical and commercial drug supply needs are met on time and on budget.

Primary Responsibilities Include:

• Leading matrixed teams internally and with the CMO to support GMP production, including all activities from initial cell banking through fill/finish.


• Work with Director to establish the strategy and priorities for the matrixed teams to ensure successful execution of operational and program objectives.

• Establish business processes and cross-functional relationships with internal/external partners, including senior leaders at the CMO.


• Ensuring that all contractual obligations with our CMOs are met to Sarepta Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition.


• Authoring and/ or review of Quality System documentation, including technical reports, deviations and change controls. It is expected for this person to provide manufacturing technical expertise in meetings related to QMS documentation.


• Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally.


• Lead or drive the resolution of major and critical deviation investigations.


• Partner with Process Development and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods.

Education and Skills Requirements:

• Degree in Engineering or Life Sciences, with 10+ years of relevant industry experience.


• Experience leading internal and joint matrixed teams responsible for oversight of CMO Operations.


• Experience with Gene therapy or Biologics BDS/ DP production to leverage for production troubleshooting.


• Knowledge of GMP regulations and a commitment to operational excellence.


• Strong project management, organizational, collaboration and conflict resolution skills and experience.


• Experience with technology transfer/vendor management and process characterization/validation (preferred).


• Excellent communication skills and ability to influence across multiple functions.


• 20% travel anticipated.

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.