Associate Specialist, Operations (Onsite)

Role: SSO Operations Specialist supporting GMP manufacturing at a pilot plant within the Small Molecule Process R&D organization. Primary objectives include executing batch production, ensuring facility readiness, and maintaining compliance with safety, environmental, and cGMP standards to support process development, technology transfer, and supply of APIs for clinical trials. Responsibilities encompass equipment setup, wet and dry chemistry operations, troubleshooting, process improvements, incident analysis, and training new staff. Qualifications: Associate degree in a relevant technical field or high school diploma with 4+ years of experience in pharmaceutical or chemical manufacturing. Skills required include strong communication, mechanical aptitude, technical writing, and shift work capability. Preferred experience includes pilot plant or manufacturing operations, process scale-up, and knowledge of cGMPs, GDP, and S&E regulations; Lean Six Sigma certification is a plus. High-Value: Focus on small molecule GMP processes, pilot scale, early-stage API supply, and cross-functional collaboration. Work setup: onsite in the US with 10% travel; shift-based schedule with potential overtime.