Technology Transfer Expert
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities include, but are not limited to:
- 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 sending unit specific process 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.
- Coordination of preparation of readiness for campaign start-up (under TT).
- Establish and update procedures & templates for technology transfer.
- Contribute to process improvement and optimizations for drug substance manufacturing technology transfers.
If you have:
- Higher education in the field: biotechnology, pharmacy or related.
- Min. 5 years of professional experience in the biotechnology or pharmaceutical/medical industry.
- 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.
- Very good command of the English language.
- 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.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Private pension plan.
- Relocation package.
- And more…
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.