Process Specialist - Manufacturing
Core
Provide technical support for manufacturing processes, resolve process challenges, and drive continuous improvement in a cGMP environment.
Role type
Manufacturing Process Specialist (Associate through Senior level)
Builds
Production programs for life-changing medicines
Domain
Biopharmaceutical manufacturing (drug substance/product)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing experience, process troubleshooting, SOP writing, change control, CAPA implementation, cross-functional collaboration, cleanroom gowning procedures, physical stamina for 10-hour shifts
Preferred skills
Drug substance or drug product manufacturing process familiarity
Technologies
Quality system, controlled documents, batch sheets, procedure files
Responsibilities
Liaise with process science and technology transfer teams on process transfer and startup; resolve process problems on and off the production floor; write and review SOPs and modify process method files; support CAPA implementation and investigate process variances; partner cross-functionally to resolve process issues; support Right First Time programs; represent Manufacturing during regulatory and client audits
Seniority
Associate (0–2 years), Specialist (2+ years), Senior (5+ years)