Associate Director / Director, CMC Product Development

Role: Lead CMC (Chemistry, Manufacturing, Controls) function for complex clinical development programs, managing cross-functional teams and external partners to develop and execute CMC strategies aligned with asset milestones. Responsibilities: create development plans, oversee regulatory communications, lead team meetings, manage outsourcing contracts, and ensure compliance with global standards. Scope includes late-discovery through commercial manufacturing, covering biologics, NCEs, NBEs, ADCs, toxins, and gene/cell therapies. Collaborates with Clinical, Regulatory, Quality, and Operations teams to support global filings and approvals. Qualifications: Bachelor's (12+ yrs), Master's (10+ yrs), or PhD (8+ yrs) with relevant drug development and CMC expertise; strong scientific communication skills; regulatory knowledge; leadership and negotiation capabilities. Preferred: experience in biologics, advanced modalities, and cross-functional leadership in global settings. Reports to senior management, with 0-3 direct reports. Location: flexible, with no specific work setup or travel specified.