What are the responsibilities and job description for the CMC Coordinator, Associate Director position at Sarepta Therapeutics?
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 limb-girdle 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.
We're 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 work-life 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: https://www.sarepta.com/join-us
The Importance of the Role
The Senior Manager/Associate Director, CMC Coordinator will report to the Executive Director of RNA Manufacturing and coordinate CMC timelines, actions, and deliverables required to advance Sarepta's licensed siRNA programs portfolio. The role will work closely with internal CMC, Clinical, Regulatory, and Finance teams as well as having external-facing scope ensuring constructive CMC collaboration with our license partner. As programs advance in the clinic and/or reach commercialization, the role will help build a team to support the expanding number of programs and commercial phase requirements.The position requires interactions with technical experts and teams from various departments to ensure cross-functional alignment within technical operations, R&D, clinical, commercial, and regulatory functions. The role will help drive CMC operational and quality aspects of siRNA programs. The candidate will manage stakeholder relationships, facilitate meetings, and maintain project documentation.
The Opportunity to Make a Difference
- Coordinate internal and partnered siRNA program(s) activities to advance the siRNA portfolio by driving cross-functional engagement between technical operations, clinical, non-clinical, and regulatory.
- Implement process(es) to ensure successful CMC progression of the siRNA portfolio from research to clinical development through commercial.
- Responsible for tracking program milestones and timelines, supporting strategy setting, coordinating with supply planning teams, providing risk assessments, and project execution.
- With management, coordinate the CMC function siRNA collaboration with Sarepta's external partner. Engage with stakeholders (internal and external) to ensure timely implementation of project objectives.
- Facilitate and organize internal and external meetings, manage action items, project deliverables, timelines, and accountabilities. Work independently and in diverse teams to accomplish project goals.
- Maintain detailed project documentation for knowledge management.
- Demonstrate an understanding of company priorities, objectives and project timelines. Manage critical-path activities, proactively identify and escalate issues, and help to resolve them.
- 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.
More about You
A combination of skills, experience, education, and training will ensure success in the role.
Education and Experience:
- B.S. (M.S. Preferred) in Chemistry or Chemical/Biochemical Engineering, chemical engineering, biochemistry, or other relevant technical discipline
- >8 years (with M.S.) or >10 years (with B.S) of pharmaceutical/biotech industry work experience with time spent in a variety of CMC roles such as (but not limited to) manufacturing, Quality, CMC Regulatory, Business Operations, Supply Chain, and/or Process/Analytical Development.
- Working knowledge of the pharmaceutical lifecycle from discovery, through clinical and commercialization
- Working knowledge of CMC operations and quality requirements
- Working understanding of ICH, FDA, EMA regulations and regulatory filings for pharmaceuticals
- Track record of managing complex projects successfully, influencing upward/horizontally/vertically in an organization, and implementing business systems and process
- Experienced with CMC business operations, contract negotiations, purchase orders, invoicing
- Experience with supply modeling, inventory systems, and demand forecasting
Skills:
- Proven leader with ability to influence cross-functionally with and without authority
- Excellent project management and organization skills with extensive experience using Microsoft Suite and SmartSheets
- Able to handle multi-task workload and perform effectively under deadlines
- High level of clarity in verbal and written communication
- Strategic thinker with ability to develop business-cases for endorsement
- Excellent budgeting and contract negotiation skills
- Position requires regular (<10%) domestic and/or international travel
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're 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.
