Company: Confidential
Job Title: VP, Head, CMC, mRNA Therapeutics
Job Number: 85882
Location: Cambridge, US
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.
Application Deadline: 2024-12-02
To apply for this job please visit jobrxiv.org.