Executive Director, CMC Technical Operations - REMOTE East Coast Based
About The Position
Beacon Therapeutics is seeking a passionate individual to join their diverse, multi-national team focused on gene therapy. As the Executive Director, CMC Technical Operations, you will be responsible for strengthening CMC execution for late-stage gene therapy programs. This includes managing market-facing supply chain activities with 3PL and 4PL partners, ensuring CMC program activities are on schedule, issues are resolved, and stakeholders are aligned internally and externally. The role requires a strategic mindset, strong leadership, and the ability to navigate complex challenges to bring treatments to patients.
Requirements
- Multi-disciplinary late-stage submission/launch experience in biopharma, preferably gene therapies, with a supply chain focus.
- Strong CMC fundamentals (CQAs, CPPs, etc) and strategic program optimization mindset.
- Demonstrated success influencing senior, multinational stakeholders.
- Clear, defined, and direct experience of building-out 3PL and 4PL supply chains for biopharmaceuticals AND a solid understanding of biopharmaceutical technical fundamentals (CPPs, CQAs) combined with a senior profile capable of managing senior stakeholders (internal, external) are key/must-have requirements for this role.
- Ready to broaden your CMC leadership scope toward enterprise-level ownership.
Responsibilities
- Drive the selection, establishment, and build-out of 3PL and 4PL partners to ensure a robust commercial supply chain for our lead product.
- Ensure management of critical external partners at a senior level across analytics, DS, and DP manufacturing.
- Develop and maintain CMC guidance and decision frameworks; Support Area Leads/ senior CMC leaders (direct/indirect) to actively resolve programme issues (internal or external).
- Ensure proactive communications of progress vs plan with internal and external stakeholders.
- Provide cross-functional technical leadership spanning viral vector production, analytics, quality, regulatory, and supply.
- Support and guide late-stage submission and launch readiness, translating strategy into executable CMC plans.
- Navigate complex technical and organizational challenges with clear, influential communication.
Benefits
- Medical, Dental, and Vision coverage
- 401(k)
- Life Insurance
- Health Savings Account (HSA) and Flexible Spending Account (FSA) options
- Employer paid STD & LTD benefits
- Paid Time Off
- Employee Discounts
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
No Education Listed
