Associate Director, Technical Operations

Role: Senior CMC Director overseeing development, execution, and oversight of CMC strategies for small molecule programs from Phase I to commercial. Responsibilities: lead external manufacturing partnerships, manage technology transfer, process validation, and cGMP manufacturing; review regulatory filings and specifications; ensure compliance and support inspections; provide technical leadership and mentorship; author regulatory documentation. Requirements: Bachelor's in Process/Chemical Engineering, Life Sciences, or related field; 8+ years of progressive cGMP CMC experience in small molecules, biologics, or peptides; demonstrated leadership in drug development and manufacturing. High-Value: small molecule development, Phase I-III clinical trials, CMC strategy, process validation, regulatory submissions, cGMP manufacturing, global collaborations, travel up to 10%. Work Setup: remote with occasional domestic/international travel.