Associate Specialist, Operations (Onsite)

Role: Support the startup, testing, and operational activities of a new potent, multi-modality drug substance GMP manufacturing facility, including equipment setup, system qualification, and process support. Responsibilities: contribute to equipment and facility testing, develop procedures for operations and maintenance, assist in process scale-up and troubleshooting of wet chemistry and powder processing operations, and support related GMP pilot plant activities. Requirements: Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field plus 1+ year relevant experience; strong mechanical aptitude, interpersonal, organizational, and communication skills; problem-solving ability; proficiency in technical documentation. Preferred: GMP clinical or manufacturing support experience, equipment startup/qualification, small molecule process development, containment systems, automation (DeltaV, PLC), Lean Six Sigma, and knowledge of process hazard analyses. High-Value: involvement in potent drug substance manufacturing, multi-modality development (small molecules, peptides, bioconjugates), GMP compliance, pilot plant operations, and cross-functional collaboration at a large pharmaceutical R&D site. Work setup: onsite five days/week, rotating shifts, with 10% travel; role includes supporting facility startup, operations, and process development activities.