Associate Director
3 days ago
The Associate Director – R&D CMC will lead the end-to-end development of active pharmaceutical ingredients (APIs) and drug products, ensuring seamless integration between research, development, and manufacturing. This role is pivotal in designing and implementing robust CMC strategies that support regulatory compliance, operational efficiency, and product innovation.
Develop and execute CMC strategies for APIs and drug product development across preclinical, clinical, and commercial stages.
Drive formulation development and manufacturing processes for drug products, ensuring stability, scalability, and quality.
Collaborate with cross-functional teams to prepare CMC sections for regulatory submissions (INDs, IMPDs, NDAs, BLAs, and MAAs).
Lead external partnerships with contract development and manufacturing organizations (CDMOs) and other vendors to deliver on-time and quality outcomes.
Ensure compliance with global regulatory standards, providing expertise during regulatory interactions and inspections.
Identify potential risks in CMC plans for APIs and drug products, proposing and implementing effective mitigation strategies.
Stay updated on advancements in CMC-related technologies and industry trends to drive innovation and best practices.
Mentor and develop junior team members, fostering a culture of collaboration and scientific excellence.
A PhD, MSc, or equivalent in chemistry, chemical engineering, pharmaceutical sciences, or a related discipline.
~8 + years of CMC experience with a focus on APIs and drug product development in the pharmaceutical/biotechnology industry.
~ In-depth knowledge of global CMC regulatory requirements and guidance.
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