Staff Process Specialist - Manufacturing
Core
Provide on-the-floor technical direction and leadership to resolve process challenges, coach manufacturing personnel, and drive continuous improvement in biopharmaceutical production.
Role type
Staff Process Specialist (Manufacturing)
Builds
Biopharmaceutical medicines (liquid and lyophilized injectable products)
Domain
Biopharmaceutical manufacturing / cGMP
Required skills
cGMP manufacturing, process problem resolution, CAPA implementation, technology transfer, validation activities, SOP writing, regulatory filings, cross-functional collaboration, aseptic filling, lyophilization, highly automated equipment operation
Preferred skills
aseptic parenteral fill/finish operations, lyophilization, highly automated equipment qualification
Technologies
cGMP, aseptic filling, lyophilization, automated equipment
Responsibilities
Provide on-the-floor technical input to resolve process problems; Lead investigations into process variances and support CAPA; Support technology transfer and validation; Track and present technical/business metrics; Write and approve SOPs and regulatory filings; Act as system owner for manufacturing equipment; Lead continuous improvement and safety initiatives.
Seniority
Staff, hands-on IC