Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Technology Transfer Expert
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
We are looking for:
1
Technology Transfer Expert
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Leading the technology transfer – from external companies to Polpharma Biologics or internally -from other departments or sites of Polpharma to Polpharma biologics; including scale up activities
- Establishing project plans, elaborating scientifically sound technical strategies with project team, developing contingency plans, identifying risks and challenges and proposing solutions
- Reviewing and supporting Quality Risk Assessment (QRA) prior to process transfer and prior to validation; supporting adaptation of control strategy if needed
- Ensuring all relevant technical information and documentation for technology transfer is available in a timely manner and to high standard
- Supporting pre-validation / validation strategy in alignment with Validation Lead incl. process, primary packaging and supportive studies.
- Supporting Validation Lead in creation of validation protocol- report and approving these documents
- Writing Manufacturing Process Transfer Documents (protocol and report)
- Performing technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determining scope/design of technical batches and engineering batches for transfer
- Providing input into overall project strategy and plans including timelines
- Contributing to process improvement and optimization for process transfers
- Establishing procedures and templates for technology transfer
- Ensuring project tracking documentation/tools are updated according to plan
- Contributing to HA inspection readiness
- Supporting creation of Master Batch Records
- Participating in R&D and Production meeting for process development and process transfer
- Organizing the R&D, QC/QA and Production meeting for process development and process transfer
- Reviewing key documents and coordinating input for relevant registration documents for accuracy and completeness (as appropriate)
What do we expect?
- Excellent understanding of biologics manufacturing process science and technologies, technical learning, quality and compliance
- Experience with technology transfer and scale-up
- Knowledge of cGMP and FDA requirements for technology transfer
- Experience with single-use technology as well as stainless steel systems would be of advantage
- Experience in project management would be of advantage
- Excellent communication and interpersonal skills
- Action-oriented, problem-solving and with drive for results
- Good organizational and planning 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.