Executive Director, External Manufacturing & Supply Chain

Role Summary

Executive Director, External Manufacturing & Supply Chain. Lead technical operations with internal and external partners to ensure robust supply of CRISPR products, overseeing external manufacturing (CMOs/CDMOs), clinical supply management, material handling, packaging, labeling, shipping, and distribution. Manage cross-functional teams, align with CMC, clinical operations, and drive scalable, compliant supply chain for allogeneic cell therapies and in vivo lipid nanoparticle therapies. Travel required up to 20%.

Responsibilities

• Building and maintaining strategic and operational relationships with CRISPR‚Äôs CMOs.
• Manage CMO manufacturing operations and deliverables to ensure supply of materials; track delivery against objectives; manage changes; drive performance.
• Manage all clinical supply activities for clinical trials across allogeneic and in vivo therapies.
• Manage drug product shipping, labeling and distribution to worldwide clinical sites via a network of vendors.
• Lead cross-functional teams; ensure accountability across functions and programs.
• Maintain financial responsibility for CMO and vendor spend; manage budgets, statements of work, requisitions, and purchase orders.
• Provide regulatory filing support (IND, BLA, etc.) as needed.
• Oversee CMO due diligence during new CMO selection to assess capabilities and risks.
• Identify and escalate business-critical issues affecting supply and timelines; provide recommendations and solutions.
• Align objectives with the CMC team, clinical operations, and other functions; represent CMOs in strategic decisions.
• Engage in contract negotiation/review; monitor contracts for compliance.
• Develop strong relationships with internal leaders to align program objectives.
• Maintain information flow during project execution to monitor relationships with CDMOs and vendors.
• Coordinate and manage CMO governance meetings in partnership with program managers.
• Provide leadership to drive a fast-paced, efficient learning culture.
• Champion a collaborative, data-driven, results-focused culture.

Qualifications

• BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related field.
• 15‚Äì20+ years in biopharmaceutical manufacturing, technical operations, supply chain, or process development; fluent in cGMP.
• Experience with third parties and CDMOs for manufacturing operations and clinical supply chain management.
• Ability to influence and communicate with senior management; strong mentoring and team development.
• Collaborative, results-driven, and able to execute to completion; comfortable with ambiguity.
• Self-driven, data-informed problem solver; strong leadership and relationship-building.
• Domestic and international travel availability.

Preferred Qualifications

• Advanced degree (PhD or MBA).
• Strong background in aseptic processing.
• Experience in commercialization of new assets and management of post-approval lifecycle.

Skills

• External manufacturing management
• Clinical supply chain management
• CMO/CDMO governance and contract management
• Regulatory filing support (IND/BLA)
• Cross-functional leadership and matrix management
• Inventory and material management
• Planning, budgeting, and financial stewardship
• Strategic negotiation and relationship building