Director CMC Project Lead
Director CMC Project Lead
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$ 180000 - 225000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
Reporting to the head of CMC Program Management the Director will lead crossfunctional teams within Technical Operations to deliver the CMC development of Sareptas Gene Therapy and RNA portfolio. Working as a member of the Global Program Team he/she will be responsible for providing program management and leadership of CMC activities working closely with internal technical functions and external partners. He/she will be a recognized expert in drug development with knowledge of phase appropriate Quality systems and global Health Authority requirements and will manage the logistical and operational aspects of programs in preclinical clinical registrational or commercial stages. The position requires indepth interactions with technical experts quality and regulatory experts researchers manufacturing and distribution teams from various functions.The Opportunity to Make a Difference
- Lead the CMC strategy and program activities of internal and partnered capabilities critical for the successful advancement of Sareptas Gene Therapy & RNA portfolio.
- Accountable for interdependencies across functions between tech ops and clinical nonclinical quality and regulatory to support of integrated program plans.
- Provide strategic and operational guidance on CMC aspects of programs evaluating various scenarios and simplifying concepts and strategies orally and in writing
- Partner with global development teams and governance committees as tech ops lead and serve as the liaison to articulate and negotiate CMC strategy with the overall asset strategy.
- Develop and implement process(es) to ensure successful transition and alignment of the portfolio from research to development through commercial.
- Responsible for all operational aspects of assigned projects including stakeholder management project scope strategy risk planning resourcing and project direction and closure.
- Seek crossfunctional input and feedback; frequent and effective followup and provide expertise in translating requirements into practical workable plans.
- Identify interdependencies and connections between departments and ensure integrated endtoend visibility and alignment.
- Maintain team focus on key priorities and motivate team members to work collaboratively to achieve objectives.
- Collaborate with Tech Ops project managers to implement tools and systems to ensure shared understanding of company priorities objectives and project timelines. Define and manage critical path proactively identify and escalate issues and help 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 them with team members and/or relevant functional management both internally and externally.
- Inform group members senior and/or executive management of industryrelated updates and technical knowledge.
More about You
- Advanced degree (PhD or MS) with a minimum of 10 years or Bachelors degree with a minimum of 12 years of experience in operations project management and/or scientific area
- A minimum of 8 years of relevant experience advising and consulting senior leaders in biotech/pharma roles and experience working with senior level executives in biotech/pharma is advantageous
- Exposure to a variety of modalities (small molecules biologics gene therapy others) is preferred
- Must have exceptional working knowledge of drug development and CMC technical operations and expertise in quality and regulatory areas is desired.
- Demonstrated excellence in crossfunctional team leadership and effectively managing multiple projects/priorities ensuring schedules and deliverables are met.
- Ability to manage ambiguity and troubleshoot critical issues or problems and resolves routine issues using appropriate information.
- Ability to work well in a crossfunctional fastpaced 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 writing communications skills with the capacity to present effectively to a diverse range of audiences.
- 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 Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Director
Employment Type
Full-Time
