Director, Technical Operations CMC Team Lead

Reporting to the head of CMC Management, the Director will lead critical elements of the CMC development of Sarepta’s Gene Therapy and RNA portfolio. Working as a member of the Global Program Team and leader of the CMC sub-team, he/she will be responsible for providing program management and leadership skills to plan and execute the CMC activities in close collaboration with internal technical functions and external partners. He/she will be a recognized expert in managing the logistical and operational aspects of assigned projects and/or processes. The position requires in-depth interactions with technical experts, researchers and clinical manufacturing teams from various functions and external vendors.

The CMC team lead will ensure cross-functional integration and alignment within technical operations, aligning with the R&D, clinical, commercial, and regulatory functions. The role requires strategic partnership with global program teams, articulating and negotiating CMC strategies, and overseeing CMC operational and quality aspects of programs. The candidate will coordinate CMC functions, manage stakeholder relationships, facilitate meetings, and maintain project documentation while navigating the project's critical path and addressing potential issues to advance CMC deliverables effectively.

Primary Responsibilities Include:

• Lead the program management activities of internal and partnered capabilities critical for the successful advancement of Sarepta’s portfolio.
• Accountable for inter-dependencies across functions, between technical operations and clinical, non-clinical, and regulatory to support execution of integrated program plans.
• Partner with global development teams and governance committees as tech ops lead and articulate and negotiate the CMC strategy within the overall asset strategy.
• Develop and implement process(es) to ensure successful transition and progression of the portfolio from research to development through commercial.
• Responsible for all operational aspects of assigned projects, including stakeholder engagement, project scope, strategy, risk assessment and mitigation, planning, resourcing, and project direction, execution and closure. 
• Lead coordination of the CMC functions and alliances with Sarepta’s partners.  Effectively engage with key stakeholders (internal and external) to ensure the timely implementation of project objectives.  Identify interdependencies and connections between departments and ensure integrated end-to-end visibility and alignment. 
• Facilitate and organize meetings and workgroups, manage action items, project deliverables, timelines, and accountabilities.  Works independently and in diverse teams to accomplish project goals.  
• Demonstrate an understanding of company priorities, objectives and project timelines.  Define and manage critical path, proactively identify and escalate issues and help to resolve them. 
• Maintain detailed project documentation for knowledge management.  Provide document support as needed. 
• Identify issues and obstacles that could impact the timely advancement of CMC deliverables and resolve these with team members and/or relevant functional management both internally and externally.
• Identify and communicate opportunities for change and plans for team to meet new challenges.  
• Keep abreast of industry trends and standards through attending conferences, reading publications and taking courses; contribute to the field through publications and poster sessions.

Desired Education and Skills: 

• Bachelor’s degree required and advanced degree (PhD) preferred with a minimum of 12+ years of experience in operations, project management and/or scientific area
• A minimum of 10+ years of relevant experience advising and consulting senior leaders in biotech/pharma functional business roles and experience working with senior level executives in biotech/pharma is preferred
• Exposure to a variety of modalities (small molecules, biologics, gene therapy, others) is preferred
• Must have exceptional working knowledge of CMC operations and quality and regulatory requirements. 
• Demonstrated excellence in project management and effectively managing multiple projects/priorities, ensuring schedules and deliverables are met. 
• Experience implementing systems, processes and best practices for support of cross-functional activities.
• Must have strong PC experience along with expertise in MS Office suite applications. 
• Ability to troubleshoot critical issues or problems and resolve routine issues using appropriate information. 
• Ability to work well in a cross-functional, fast-paced team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions. Proven experience coordinating among stakeholders with both business and technical priorities.  
• Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences. 
• Exercises exceptional time management skills and can successfully manage multiple tasks simultaneously. 
• Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta cultural values:  Patients First, Action, Unconventional Thinking, Talent and Integrity.

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.