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 role:
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.
Your responsibilities:
- 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
If you have:
- 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