Associate Director/Director of Pharmaceutical Development

Role: Associate Director/Director of Pharmaceutical Development overseeing drug formulation, scale-up, and manufacturing processes, with a focus on external vendor management and regulatory documentation. Responsibilities: manage process design and robustness using QbD principles, oversee CDMO partnerships for clinical and commercial batch production, author/regulatory CMC documents for global filings, lead technology transfer from discovery to manufacturing, and ensure risk mitigation across outsourced operations. Collaborate cross-functionally with analytical, quality, supply chain, and clinical teams. Manage project timelines, budgets, and vendor governance. Troubleshoot manufacturing issues and deviations at external sites. Qualifications: Ph.D., Master's, or Bachelor's in Chemistry, Pharmaceutics, Chemical Engineering, or related field; 8+ years in small molecule drug development; proven experience scaling processes from pilot to cGMP environments; minimum 3 years managing small molecule CDMOs; strong understanding of ICH guidelines (Q1-Q11), cGMP, and QbD principles. HighValue: expertise in small molecule formulation, scale-up, and technology transfer; experience with global regulatory submissions (IND, NDA, MAA); managing external vendor relationships in a cGMP setting. WorkSetup: Not specified.