Associate Director CMC
Position Overview
This role supports the development and commercialization of pharmaceutical products by leading key Chemistry, Manufacturing, and Controls (CMC) activities related to drug product development, technology transfer, manufacturing oversight, and supply chain coordination. The position collaborates cross-functionally with internal teams and external partners to ensure successful development, regulatory compliance, and reliable product supply throughout the product lifecycle.
Key Responsibilities
• Evaluate and support selection of external manufacturing partners (e.g., CDMOs) in collaboration with Quality, Regulatory, and other functional groups, including participation in technical and supply agreement discussions.
• Manage relationships with contract manufacturing and development partners, coordinating multidisciplinary teams to support drug product development and manufacturing activities.
• Lead or support technical development efforts such as process scale-up, optimization, and manufacturing readiness activities for drug product programs.
• Review manufacturing and analytical documentation, including batch records, testing results, specifications, and stability data, as appropriate.
• Ensure alignment with applicable regulatory and quality standards by collaborating with Quality teams on documentation reviews, investigations, and product disposition.
• Contribute to global regulatory CMC strategy and support preparation of regulatory submissions and related documentation.
• Participate in interactions with regulatory authorities as part of cross-functional teams when required.
• Maintain organized documentation for CMC-related activities within electronic quality or document management systems.
• Support project planning activities including timelines, resource tracking, and coordination with external partners.
Qualifications
• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific field; advanced degree preferred.
• Significant industry experience supporting CMC development activities for pharmaceutical products.
• Familiarity with cGMP requirements, relevant regulatory guidelines, and drug product manufacturing practices.
• Experience supporting regulatory submissions and interactions related to CMC documentation.
• Demonstrated experience working with external development or manufacturing partners.
• Strong problem-solving, project management, and communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.
• Willingness to travel occasionally as needed.
Apply Now
Apply Now
This role supports the development and commercialization of pharmaceutical products by leading key Chemistry, Manufacturing, and Controls (CMC) activities related to drug product development, technology transfer, manufacturing oversight, and supply chain coordination. The position collaborates cross-functionally with internal teams and external partners to ensure successful development, regulatory compliance, and reliable product supply throughout the product lifecycle.
Key Responsibilities
• Evaluate and support selection of external manufacturing partners (e.g., CDMOs) in collaboration with Quality, Regulatory, and other functional groups, including participation in technical and supply agreement discussions.
• Manage relationships with contract manufacturing and development partners, coordinating multidisciplinary teams to support drug product development and manufacturing activities.
• Lead or support technical development efforts such as process scale-up, optimization, and manufacturing readiness activities for drug product programs.
• Review manufacturing and analytical documentation, including batch records, testing results, specifications, and stability data, as appropriate.
• Ensure alignment with applicable regulatory and quality standards by collaborating with Quality teams on documentation reviews, investigations, and product disposition.
• Contribute to global regulatory CMC strategy and support preparation of regulatory submissions and related documentation.
• Participate in interactions with regulatory authorities as part of cross-functional teams when required.
• Maintain organized documentation for CMC-related activities within electronic quality or document management systems.
• Support project planning activities including timelines, resource tracking, and coordination with external partners.
Qualifications
• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific field; advanced degree preferred.
• Significant industry experience supporting CMC development activities for pharmaceutical products.
• Familiarity with cGMP requirements, relevant regulatory guidelines, and drug product manufacturing practices.
• Experience supporting regulatory submissions and interactions related to CMC documentation.
• Demonstrated experience working with external development or manufacturing partners.
• Strong problem-solving, project management, and communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.
• Willingness to travel occasionally as needed.
Apply Now
Apply Now