Technical Operations Manager – SME Sterile Manufacture (w/m/d)
Core
Subject Matter Expert for parenteral product transfers, conducting risk assessments, defining CMC parameters, and managing documentation for manufacturing transfers.
Role type
Senior IC Technical Operations Manager (Sterile Manufacturing)
Builds
Product transfer documentation and risk assessments for parenteral products
Domain
Pharmaceutical manufacturing (sterile parenterals)
Required skills
Risk assessment, CMC dossier knowledge, GMP compliance, Project management, Master documentation creation, Quality deviation analysis, Cross-functional collaboration
Preferred skills
Regulatory document knowledge (eCTD), Additional foreign language, MS Office, Copilot
Technologies
MS Office, Copilot
Responsibilities
Conduct product-specific risk assessments for parenteral transfers, Define CMC, CQA, and CPP parameters, Create master documentation for product transfers, Evaluate transfer data and generate GMP conclusions, Support quality deviation handling during transfers, Coordinate marketing aspects with Supply and Sales teams, Handle administrative transfer requirements
Seniority
Senior, hands-on IC
