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