The University of Texas MD Anderson Cancer Center
VP, Head, CMC, mRNA Therapeutics
The University of Texas MD Anderson Cancer Center, Cambridge, Massachusetts, us, 02140
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.
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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.
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