About the Role
We are seeking an experienced and visionary Head of CMC Development to lead and manage our Chemistry, Manufacturing, and Controls (CMC) team. This is a senior leadership role with responsibility for shaping CMC strategy, driving process development, and ensuring seamless scale-up and supply of clinical materials. The position covers small molecules and antibodies, with a strong emphasis on innovation, compliance, and cross-functional collaboration
Key Responsibilities
* Strategic Leadership: Provide direction to a team of six CMC experts, setting phase-appropriate development strategies.
* Process & Analytical Development: Lead the design, optimization, and validation of manufacturing processes and analytical methods.
* Technology Transfer: Ensure smooth transfer of processes from development to manufacturing with internal and external partners.
* Quality & Compliance: Guarantee adherence to regulatory requirements and quality standards, working closely with QA and Regulatory Affairs.
* Business Development: Support due diligence and provide CMC expertise for small molecules, antibodies, and drug delivery technologies.
* Cross-Functional Collaboration: Partner with Drug Discovery, Medicinal Chemistry, and Product Development teams to align CMC activities with overall goals.
* Team Building: Mentor and inspire a high-performing team, fostering a culture of collaboration, accountability, and innovation.
Qualifications
* Advanced degree (Ph.D., M.S., or equivalent) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
* 12+ years of experience in pharmaceutical or biotechnology CMC development.
* Proven track record of leadership in CMC strategy, team management, and regulatory compliance.
* Strong communication skills with the ability to convey complex technical information to diverse stakeholders.
* Demonstrated success in building and leading high-performing teams.
* Ability to thrive in a dynamic, fast-paced environment.