Principal Scientist, Parenteral ExM MS&T

Role: Principal Scientist in External Manufacturing (ExM) Manufacturing Science & Technology, providing technical leadership for parenteral drug product manufacturing at North American CMOs. Responsibilities: oversee process verification and operational excellence initiatives, serve as technical point of contact during technical transfers and commercial manufacturing, lead investigations for out-of-spec results, support regulatory and CMC documentation, and manage change requests across sites. Requirements: Bachelor's in Chemical Engineering, Bioprocess, Microbiology, or related; 9-12 years (BS), 6-9 years (MS), or 4-6 years (PhD) experience in sterile/parenteral manufacturing; deep expertise in cGMP, process validation, risk assessment, and regulatory compliance; proficiency in statistical analysis tools like Minitab or JMP. Preferred qualifications include advanced degrees, and experience with process improvements, regulatory interactions, and cross-functional collaboration. HighValue: sterile/parenteral drug manufacturing, process robustness, technical transfers, root cause investigations, regulatory support, cGMP compliance, 20% travel. WorkSetup: onsite in New Brunswick, NJ, with travel.