Associate Director / Director, CMC Product Development
Core
Independently manages complex clinical development programs and leads CMC teams to create development strategies aligning with asset strategy for new chemical and biological entities, including gene and cell therapies.
Role type
Senior IC CMC Product Development Director
Builds
Differentiated pharmaceutical products from late discovery to commercial manufacturing
Domain
Biopharmaceuticals / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC interdisciplinary expertise, pharmaceutical drug development process knowledge, regulatory requirements knowledge, scientific writing, verbal communication, negotiating, influencing, leadership, budget management, contract negotiation, risk mitigation, cross-functional team leadership
Preferred skills
Entrepreneurial thinking, creative resource management, mentoring, stakeholder relationship building
Technologies
Scientific instrumentation, CMC technical functions
Responsibilities
Create CMC development plans with timelines and risk mitigations, lead CMC teams and PPDSTs, ensure compliance with global regulatory and quality requirements, participate in meetings with regulatory authorities, manage outsourcing contracts and budgets, mentor team members, drive strategic alignment with development sciences functions
Seniority
Director, strategic leadership with hands-on management
