Staff Process Specialist - Manufacturing
Core
Provide on-the-floor technical direction and leadership to resolve process challenges, lead investigations, and drive continuous improvement in biopharmaceutical manufacturing.
Role type
Staff Process Specialist (Manufacturing)
Builds
Biopharmaceutical medicines (liquid and lyophilized injectable products)
Domain
Biopharmaceutical manufacturing / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing, process problem resolution, CAPA implementation, technology transfer, equipment validation, SOP writing, regulatory audit representation, cross-functional collaboration
Preferred skills
aseptic parenteral fill/finish operations, lyophilization, highly automated equipment operation and qualification
Technologies
aseptic filling, lyophilization, automated manufacturing equipment
Responsibilities
Provide on-the-floor technical input to resolve process problems; Lead investigations into process variances and support CAPA implementation; Support technology transfer of manufacturing processes; Track, trend, and present technical and business process metrics; Write, review, and approve SOPs and regulatory filings; Act as system owner for defined manufacturing equipment; Lead and implement continuous improvement initiatives
Seniority
Staff, hands-on IC with strategic oversight