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Supervising the introduction of new products to the stage of launching commercial production, especially leading of the drug substance manufacturing technology transfers and supporting the process validation from project perspective.
- Establish TT plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles, and propose solutions. Asses & plan site resources needs (FTEs, investments, external costs), strategies and timelines
- Form/lead project team, set priorities for project & project team meetings, coordinate project team activities, ensure that EHS and GMP guidelines are met
- Coordinate activities between departments involved in Technology Transfer / Process Validation
- Contribute to elaboration of pre-validation/validation strategy in alignment with process validation lead, including supportive studies
- Support Process Validation Lead/ Process Validation Expert in creation of validation protocol and report
- Initiate monitoring and ongoing process verification phase & compilation of first APQR
- Contribute to process improvement and optimizations for drug substance manufacturing technology transfers
- Provide input into overall project strategy and plans including timelines and budget
- Ensure that project tracking documentation/tools are updated according to plan
- Elaborate manufacturing process transfer main documents (protocol, report).
- Preparation, review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate)
- Participation in preparations for and in the inspections of pharmaceutical regulatory authorities
- Higher education in the field: biotechnology, pharmacy or related
- 5 years of professional experience in the biotechnology or pharmaceutical/medical industry
- Experience in Technology Transfer of manufacturing processes
- Experience in working with recombinant proteins on a production scale
- Experience in keeping process and project documentation
- Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines
- Practical knowledge of Technology Transfer in pharmaceutical production,
- Fluent English skills, both speaking and writing
- The ability to organize work well and to cooperate in a team
- Ability to identify and solve problems independently
- Very good knowledge of MS Office and MS Project
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.