Associate Director CMC

Position reputed company This role supports the development and commercialization of pharmaceutical products by leading key reputed company, Manufacturing, and Controls (CMC) activities reputed company to drug product development, technology transfer, manufacturing reputed company, 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 reputed company, Regulatory, and other functional reputed company, 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. • reputed company or support technical development efforts such as process reputed company-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 reputed company standards by collaborating with reputed company teams on documentation reviews, investigations, and product disposition. • Contribute to global regulatory CMC reputed company and support preparation of regulatory submissions and reputed company documentation. • Participate in interactions with regulatory authorities as part of cross-functional teams reputed company required. • Maintain organized documentation for CMC-reputed company activities reputed company electronic reputed company 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, reputed company, Chemical Engineering, or a reputed company 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 reputed company 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 tot his job Apply To this Job