Vodja tehnoloških prenosov (m/ž/d) / Technical Transfer Lead (m/f/d)
Core
Lead technical transfer and validation for aseptic manufacturing technologies at a global center of excellence, ensuring quality risk assessments and regulatory compliance for new product launches.
Role type
Senior Technical Transfer Lead (Pharmaceutical Manufacturing)
Builds
Aseptic drug manufacturing capabilities and validated production lines for innovative therapies.
Domain
Pharmaceutical manufacturing / Aseptic production
Required skills
Quality risk assessment, validation strategy definition, project management, technical documentation management, resource planning, regulatory compliance oversight, team leadership
Preferred skills
Master's degree in Pharmacy, Chemistry, or Natural Sciences, 5+ years in pharmaceutical manufacturing, English fluency
Technologies
Microsoft Office
Responsibilities
Review and update quality risk assessments prior to transfer and validation; Define pre-validation and validation strategies including process, cleaning, and packaging; Coordinate technical, regulatory, and validation batches; Perform local oversight of system changes and ensure approval; Establish project plans and scientifically justified technical strategies; Assess and plan resource needs and obtain management approval for project costs.
Seniority
Senior, hands-on IC