Technical Transfer Lead (m/f/d)
novartis · Ljubljana
Opis delovnega mesta
About the role
Novartis is looking for a Technical Transfer Lead for its Ljubljana Aseptic Manufacturing site, which is being built as a global centre of excellence for launching and producing innovative aseptic medicines. The role involves working with experts from Slovenia and across the Novartis organisation to set new standards of excellence in pharmaceutical manufacturing. The position is based in Ljubljana, Slovenia, and is listed as hybrid; relocation support is not offered.
Key responsibilities
- Review and update quality risk assessments before transfer and validation, and adjust control strategies as needed
- Ensure all critical technical information and validation documentation is available
- Define pre-validation and validation strategies, including process, cleaning, packaging and related studies (e.g. hold times)
- Coordinate technical, regulatory and validation batches at the site
- Review validation protocols and reports
- Perform local oversight of system changes and ensure their approval and closure
- Establish project plans, prepare scientifically justified technical strategies, contingency plans and resource plans, and propose solutions to obstacles
- Assess resource needs and obtain management approval for project costs, strategies and timelines
- Assemble and lead the site project team, set priorities and ensure compliance with guidelines
Required profile
- University degree in pharmacy, chemistry or another natural science; a master's degree is desirable
- At least 5 years of experience in pharmaceutical manufacturing is desirable
- Active knowledge of English
- Knowledge of Microsoft Office tools
What we offer
- Annual bonus of 12% of annual pay
- Vacation allowance and business performance award
- Voluntary supplementary pension insurance and accident insurance
- Collective health insurance for specialists and Care Connect mental health support
- Transport, meals and other statutory benefits
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novartis
Ljubljana
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