Director of Manufacturing

My client is an early-stage biotech company specializing in viral vaccines. As we advance into Phase 2 and Phase 3 clinical trials, we seek a Director of CMC (Chemistry, Manufacturing, and Controls) Manufacturing to lead our manufacturing processes.

The Director of CMC Manufacturing will oversee all aspects of manufacturing operations for our viral vaccine candidates. The ideal candidate will have extensive expertise in viral vaccine manufacturing, particularly in advancing products through Phase 2 and Phase 3 clinical trials. This role requires strategic leadership, in-depth knowledge of CMC processes, and the ability to collaborate with government agencies, including BARDA.

Key Responsibilities:

• Manage manufacturing processes for viral vaccines transitioning from Phase 1 to Phase 2 and Phase 3 trials.
• Lead assay development and validation activities.
• Collaborate with government contacts, including BARDA, for funding and regulatory compliance.
• Develop and implement manufacturing strategies aligning with clinical and regulatory goals.
• Ensure scalability and reproducibility of manufacturing processes.
• Mentor and manage a team of manufacturing scientists and engineers.
• Coordinate with cross-functional teams to ensure seamless progression of vaccine candidates.
• Monitor and report on manufacturing performance metrics.

Qualifications:

• Advanced degree in a relevant scientific or engineering discipline.
• Proven experience in viral vaccine manufacturing, with a track record in Phase 2 and Phase 3 trials.
• In-depth knowledge of CMC processes and regulatory requirements.
• Experience working with government agencies, particularly BARDA.
• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.