Primary responsibilities include:

• Lead a team of CMC project leads and project managers that oversee individual pipelines projects and ensure progression of CMC activities.
• Guide the organization in optimizing business processes to support effective CMC management and communication.
• Facilitate and lead the CMC Steering Committee forums to ensure functional leadership alignment within Technical Operations
• Interface with R&D and Commercial to ensure strategic alignment on supporting portfolio through development.
• Support business development and alliance management activities and ensure CMC consideration and leadership is provided.
• Lead initiatives to drive excellence and efficiency in progressing projects through development within Technical Operations.
• Provide input on technical, regulatory, quality and manufacturing aspects as a leader within Technical Operations.
• Collaborate with regulatory affairs teams to establish robust authoring, review and content strategy practices.

Education and Skills Requirements:

• M.S./Ph. D in Pharmaceutical Sciences, Chemical/Biochemical Engineering, or a related discipline with technical experience relevant to areas within the quantitative sciences disciplines
• Extensive experience (20+ years) in the pharmaceutical industry, with specific experience within areas of CMC development and with progression of programs through clinical development
• 7+ years in a leadership role as an effective people manager
• Local candidate preferred with an onsite presence at our Burlington MA office 3+ days a week based on business need
• Strong technical/scientific experience and health agency interaction experience in product development and commercialization
• Well-developed understanding all aspects of drug development with includes direct experience in working with research, clinical and/or commercial organization
• Demonstrated experience in leading without authority and in leading strategic and transformative initiatives
• Direct experience in RNA-based and/or Gene Therapy based modalities are preferred, but not required
• Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively across CMC functional areas
• Extensive experience with regulations and requirements such as cGMP, ICH, USP, JP and global CMC regulatory expectations and proven track-record of resolving complex issues with health authorities.
• Experience authoring regulatory filings and interacting directly with Health Authorities
• 10% domestic and international travel required

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.