Director of CMC & Manufacturing

Director of CMC & Manufacturing (Biologics)

Boston, MA

Summary

The Head of CMC will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC) for traditional biologics. This role involves strategic planning, execution, and management of CMC activities to ensure the successful development and commercialization of biologic products.

Key Responsibilities:

• Strategic Leadership: Develop and implement the long-term CMC strategy for traditional biologics, aligning with the company's overall goals and objectives.
• Project Management: Lead CMC project management activities from inception to completion, ensuring timelines, budgets, and quality standards are met.
• Supplier Management: Oversee the selection, contracting, and management of Contract Manufacturing Organizations (CMOs) and other external suppliers.
• CMC Documentation: Ensure comprehensive and accurate documentation of all CMC activities, including batch records, validation protocols, and regulatory submissions (IND/BLA).
• Team Leadership: Provide leadership and mentorship to the CMC team, fostering a culture of excellence and innovation.
• Cross-functional Collaboration: Work closely with other departments, including R&D, Quality, and Regulatory Affairs, to integrate CMC strategies into overall development plans.
• CMC Strategy Development: Formulate and drive the CMC strategy for traditional biologics, ensuring alignment with product development timelines and regulatory requirements.
• Process Characterization and Validation: Lead efforts in process characterization, validation, and technology transfer to ensure robust and scalable manufacturing processes.
• Budget Management: Develop and manage the CMC budget, ensuring efficient allocation of resources and cost-effective operations.

Qualifications:

• Ph.D. or Master's degree in Biochemistry, Chemical Engineering, or a related field.
• Minimum of 10 years of experience in CMC roles within the biologics industry, with a strong background in traditional biologics (Open to other modalities).
• Proven track record in CMC strategy and execution, excellent project management skills, and strong leadership abilities.
• In-depth understanding of regulatory requirements for biologics, GMP, and quality systems.
• Excellent verbal and written communication skills, with the ability to effectively interact with internal teams and external partners.