Associate Director, Manufacturing Science and Technology – Drug Product

Role: Associate Director, Manufacturing Science and Technology – Drug Product, overseeing technical and operational support for small molecule drug product manufacturing in late-stage clinical and commercial phases. Responsibilities: provide person-in-plant support during manufacturing at CMOs, lead technology transfer, process validation, and process improvements; coordinate manufacturing, packaging, and labeling in compliance with GMP, GCP, and ICH; author regulatory documentation including deviations, protocols, and CMC sections; monitor vendor performance and ensure timely production; drive continuous process improvements and troubleshoot manufacturing issues. Requirements: Bachelor’s in scientific or engineering discipline (chemical engineering preferred); minimum 8 years in small molecule formulation and manufacturing, with at least 3 years in process validation, technology transfer, and vendor oversight within pharma, biotech, or CMO settings. Skills: expertise in oral solid and liquid dosage forms, GMP, GCP, ICH guidelines, process validation, and pharma QbD principles; leadership and project management skills; experience with domestic and international CMOs. Preferred: proficiency in Visio, JMP; team and project management experience; ability to influence without authority. High-Value: focus on late-stage clinical and commercial small molecule manufacturing, process validation, regulatory submissions, CMO oversight, and process optimization. Work Setup: office/field-based with 50-75% travel.