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…
