Director of Technical Operations and CMC Team Lead

3 days ago

Burlington, Massachusetts, United States Sarepta Therapeutics Full time
Why Sarepta?

Sarepta Therapeutics is a leading biotech company at the forefront of genetic medicine. We have a strong presence in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), with over 40 programs in various stages of development in gene therapy, RNA, and gene editing. Our commitment to patients drives our innovation, and we're seeking individuals who share our passion for making a difference.

What We Offer

At Sarepta, we prioritize our employees' well-being and offer a range of benefits and resources to support their physical, emotional, and financial health. Our comprehensive benefits package includes support for caregivers, financial wellness programs, and physical and emotional wellness initiatives. We strive to create a culture that values work-life balance and recognizes the importance of integrating personal and professional life.

The Role

We're seeking a Director, Technical Operations and CMC Team Lead, to lead critical elements of our CMC development for our Gene Therapy and RNA portfolio. As a member of our Global Program Team and leader of the CMC sub-team, you'll be responsible for providing program management and leadership skills to plan and execute CMC activities in close collaboration with internal technical functions and external partners. You'll be a recognized expert in managing logistical and operational aspects of assigned projects and/or processes, with in-depth interactions with technical experts, researchers, and clinical manufacturing teams.

Key Responsibilities
  • Lead program management activities of internal and partnered capabilities critical for the successful advancement of our 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 processes 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.
  • 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 the 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.
Requirements
  • 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.
What's Next?

We're always looking for solution-oriented, critical thinkers who are comfortable with ambiguity and candor, relish challenging themselves, and place kindness and integrity at the forefront of how they approach their peers and work. If you're passionate about making a difference in the lives of patients and are excited about the opportunity to join our team, we encourage you to apply.

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