JWe are the largest manufacturer of medicinal products and a leader of the pharmaceutical market. We operate on the markets of Central and Eastern Europe, the Caucasus and Central Asia, and we employe over 7000 people in Poland and abroad. The portfolio of Polpharma Group covers around 600 products, including life-saving medicines. "People Help People" is our motto.
Technology Transfer Expert
Location: Gdańsk
We offer:
- Fixed renumeration
- Employment contract
- Private medical care
- Training courses
- Holidsy gifts
- Sports card
- Additional insurance
- Relocation package
How we work and who we work with
- Flexible working hours
- Team work
- Over 7,000 employeesw
What job will you do?
- Leading the technology transfer – from external companies to Polpharma Biologics or internally -from other side of Polpharma to Polpharma biologics; including scale up activities
- Establish project plans, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles
- Review and support Quality Risk Assessment (QRA) prior to transfer and prior to validation; support adaptation of control strategy if needed
- Ensure all relevant technical information and documentation for technology transfer is available
- Define pre-validation / validation strategy in alignment with Validation Lead incl. process, primary packaging and supportive studies. Coordinate technical, regulatory and validation batches at site
- Support Validation Lead in creation of validation protocol- report and approve these documents
- Initiate monitoring and Ongoing Process Verification phase and compilation of the first APQR
- Write Manufacturing Process Transfer Documents (protocol and report)
- Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope/design of technical batches and engineering batches for transfer
- Provide input into overall project strategy and plans including timelines
- Contribute to process improvement and optimization for process transfers
- Establishes procedures and templates for technology transfer
- Form and lead project team - set priorities for project and project team meetings, coordinate project team activities, ensure that
- Ensure project tracking documentation/tools are updated according to plan
- Contribute to HA inspection readiness
- Support creation of Master Batch Record
- Preparing the list of BOM for initial batches during tech transfer
- Participate in R&D and Production meeting for process development and process transfer
- Organize the R&D, QC/QA and Production meeting for process development and process transfer
- Ensure site readiness for campaign start-up
- Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
What do we expect from you?
- Advanced skills in manufacturing process science and technologies, technical learning, quality and compliance
- Experience with technology transfer and scale-up
- Experience with single-use technology
- Knowledge of cGMP and FDA requirements for technology transfer
- Experience in project management would be of advantage
- Excellent communication and interpersonal skills
- Action-oriented, problem-solving and with drive for results
- Good organizational skills
- Fluent English (written and spoken).
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.