Staff Process Specialist, Fill Finish Manufacturing

Role: Senior/Principal/Staff Process Specialist in biopharmaceutical manufacturing, providing technical direction and leadership in aseptic fill/finish operations. Objectives include resolving process challenges, leading investigations, supporting technology transfer, and driving continuous improvements in cGMP environment. Responsibilities: offer on-the-floor technical support, lead investigations into process variances, support validation activities, author and review controlled documents, and act as system owner for manufacturing equipment. Collaborate cross-functionally with Process Science, Engineering, Quality, Regulatory, and Facilities teams. Requirements: BS in Life Sciences or related; 8+ to 12+ years (depending on seniority) of relevant cGMP manufacturing, engineering, or scientific experience; knowledge of sterile process manufacturing, formulation, lyophilization, and automated equipment preferred. High-Value: aseptic parenteral fill/finish, lyophilization, GMP manufacturing, process validation, technology transfer, regulatory documentation, and audits. Work setup: on-site at East Greenbush, NY, with full cleanroom gowning and physical requirements for up to 10 hours per shift.