Senior Principal Investigator, Drug Product Process Development

Role: Senior Principal Investigator in Drug Product Process Development, focusing on biologics. Objectives: lead development, validation, and manufacturing strategies to support preclinical and clinical trials, and contribute to regulatory submissions. Responsibilities: design phase-appropriate processes, oversee manufacturing activities, manage third-party manufacturers, author and review CMC sections for IND/IMPD and BLA, and ensure process validation and regulatory compliance. Collaborate with cross-functional teams including Quality, Regulatory, and Supply Chain, and manage external vendors and CDMOs, with approximately 15% travel. Qualifications: PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 15+ years in biopharma, broad experience in biologics drug product manufacturing, including sterile filtration, filling, lyophilization, and visual inspection. Expertise in CDMO management, risk management, deviation investigations, and regulatory documentation. Preferred: formulation development, lyophilization cycle development, validation, and environmental monitoring. High-Value: biologics, drug product manufacturing, CDMO oversight, regulatory submissions (IND/BLA), validation, and cross-functional project leadership. Work setup: based in Wilmington, Delaware, with domestic travel.