CMC Project Manager

Responsibilities:

• Provide scientific and technical expertise for CMC activities supporting a commercial biotech product.
• Collaborate with CMOs to manage manufacturing, ensuring quality, compliance, and timely delivery.
• Develop and execute CMC strategies aligned with company goals and regulatory standards.
• Review and approve batch records, analytical data, and technical reports.
• Contribute to regulatory submissions, including CMC sections of INDs, BLAs, and other filings.
• Lead technology transfer between internal teams and external partners.
• Support process validation and maintain specifications, test methods, and control strategies.

Experience Required:

• Strong knowledge of GMP regulations and ICH guidelines for biopharmaceutical manufacturing
• Experience managing CMOs and external partnerships
• Solid understanding of biotech drug development and manufacturing processes
• Proficient in regulatory affairs, especially CMC documentation for submissions
• Experience with lifecycle management of commercial products is a plus