Associate Director/Director of Pharmaceutical Development

Role: Associate Director/Director of Pharmaceutical Development overseeing drug formulation technology transfers, scale-up, and manufacturing processes for small molecule therapeutics. Objectives include managing external CDMO partnerships, ensuring smooth technology transfer, and supporting regulatory submissions. Responsibilities: lead late-stage drug product design, oversee clinical and commercial manufacturing, author CMC documentation for global filings (IND, NDA, MAA), and manage vendor governance and production schedules. Collaborate cross-functionally with analytical, quality, supply chain, and clinical teams; manage project budgets and risks; troubleshoot manufacturing issues; and lead process validation efforts. Qualifications: Ph.D./Master's/Bachelor’s in Chemistry, Pharmaceutics, Chemical Engineering, or related field; 8+ years in small molecule drug product development; proven experience scaling processes from pilot to cGMP/ commercial scale; 3+ years managing small molecule CDMOs; strong knowledge of ICH guidelines, cGMP standards, and QbD principles; excellent communication and negotiation skills. High-value: experience with small molecule formulations, manufacturing scale-up, and global regulatory filings; external vendor management; and technical transfer expertise. WorkSetup: not specified in the description.