VP, Head, CMC, mRNA Therapeutics

Job Title: VP, Head, CMC, mRNA

Job Number: 35451

Location: Cambridge, MA

Job Description

We are seeking an experienced VP/Head of CMC Manufacturing to lead all technical operations activities including analytical development, process optimization, and mRNA delivery for a rapidly evolving, well funded stealth mode company. This role will oversee and lead external CDMO/CMO/CRO partnerships, ensuring efficient, compliant production of mRNA-based therapeutics, drug substance, drug product and analytical development from late research development through development.

Responsibilities

• CDMO/CMO Oversight: Manage relationships with CDMOs/CMOs to ensure timely and high-quality mRNA production.
• Analytical & Process Development: Lead the development and optimization of analytical methods and manufacturing processes, ensuring scalability and compliance with regulatory standards.
• mRNA Delivery Expertise: Ensure the effective integration of delivery technologies, particularly LNPs, into the manufacturing process.
• Compliance & Quality: Ensure all manufacturing activities meet cGMP and regulatory standards.
• Contract & Risk Management: Negotiate contracts and manage risks associated with external manufacturing, ensuring alignment with business goals.
• Cross-Functional Collaboration: Work closely with internal R&D, quality, and regulatory teams to support seamless execution of CMC activities

Required Skills

• Education: Advanced degree in Chemical Engineering, Biochemical Engineering, Molecular Biology, or related field. PhD preferred.
• Experience: 10+ years in biologics or mRNA manufacturing with strong focus on analytical development, process optimization, and mRNA delivery methods like LNPs.
• CDMO/CMO Management: Proven experience managing external manufacturing partnerships and scaling processes.
• Regulatory Expertise: Deep knowledge of regulatory and cGMP standards for mRNA manufacturing.