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As a Technology Transfer Expert you will be a part of MS&T Department at Polpharma Biologics Warsaw. Your role will be to lead and support the drug substance manufacturing technology transfers on PBW side.
- Contribute to elaboration of pre-validation/validation strategy in alignment with process validation lead, including supportive studies;
- Coordinate activities between departments involved in DS batches performed as a part of Technology Transfer;
- 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;
- Act as SPOC in RU for given technology transfer project;
- Provide input into overall project strategy and plans including timelines and budget;
- 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 PBW guidelines, EHS and GMP guidelines are met;
- Ensure that project tracking documentation/tools are updated according to plan;
- Ensure timely availability of technical documentation;
- Elaborate manufacturing process transfer main documents (protocol, report). Support creation of MBR and documents related to TT;
- Review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate);
- Contribute to HA inspection readiness;
- Ensure the readiness for campaign start-up;
- Establish and update procedures & templates for technology transfer;
- Contribute to process improvement and optimizations for drug substance manufacturing technology transfers.
- Higher education in the field: biotechnology, pharmacy or related;
- Experience in Technology Transfer of manufacturing processes;
- Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines;
- Practical knowledge of Technology Transfer in pharmaceutical production;
- 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;
- Very good command of the English language.
Poznaj
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.