What are the responsibilities and job description for the Director of CMC & Manufacturing position at EPM Scientific - Phaidon International?
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.
Qualifications :
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