Technical Operations Manager – SME Sterile Manufacture (w/m/d)
Core
Subject Matter Expert leading product transfer of parenteral sterile drugs to contract manufacturers, defining technical feasibility and quality requirements.
Role type
Senior IC Technical Operations Manager (Sterile Manufacturing)
Builds
Product transfer documentation, risk assessments, and quality conclusions for contract manufacturing orders.
Domain
Pharmaceutical manufacturing (sterile parenterals) / Regulatory compliance
Required skills
Product transfer expertise, CMC dossier knowledge, GMP compliance, Risk analysis, Project management, Master documentation creation, Quality deviation handling, Cross-functional stakeholder alignment
Preferred skills
Regulatory document expertise (eCTD), Additional foreign language proficiency, MS Office and AI tools (Copilot)
Technologies
MS Office, Copilot, eCTD
Responsibilities
Conduct product-specific risk analyses for technical feasibility, Define CQAs and CPPs based on guidelines, Create master documentation for product transfers, Evaluate transfer data and generate GMP conclusions, Support quality deviation handling, Align marketing aspects with Supply and Sales teams, Handle administrative transfer requirements (via careerplan.io/jobs/2752827-technical-operations-manager-sme-sterile-manufacture-wmd)
Seniority
Senior, hands-on IC
