Associate Specialist, Operations (Onsite)

Role: SSO Operations Specialist supporting GMP manufacturing in a pilot plant for small molecule API production, primarily for clinical and development use. Responsibilities: execute batch production operations, assist with equipment setup, raw material sampling, process troubleshooting, and process knowledge capture; ensure facility readiness, compliance with safety, environmental, and GMP standards; contribute to process improvements, incident investigations, and document lessons learned; mentor new staff. Qualifications: Associate degree in Process Technology or higher, or high school diploma with 4+ years relevant manufacturing experience; strong communication, mechanical aptitude, and technical documentation skills. Preferred: experience in pilot plant or manufacturing environments, chemical process scale-up, cGMP and S&E regulations familiarity, Lean Six Sigma certification. High-value biopharma specifics: small molecule GMP manufacturing, API synthesis, wet chemistry and dry powder processing, process troubleshooting, and continuous improvement. Work setup: onsite five days/week; rotating shifts (1st/2nd); occasional overtime; no travel required.