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 Specialist
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 Specialist
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Generate robust tech transfer plans and protocols in close collaboration with biologics process & analytical development, manufacturing, QC/QA and, if applicable, external partners
- Provide technical expertise on manufacturing processes during initial risk / gap assessments and make recommendations on risk mitigation actions
- Generate technical reports to a high standard and coordinate review and approval from key stakeholders.
- Collect and review process information, data, analytical methods and perform process risk assessments / GAP analysis on processes transferred from internal or external parties
- Be responsible for the generation of accurate tech transfer plans and protocols in close collaboration with development and production teams
- Coordinate and execute process risk assessments for scale-up operations and transfer to large scale production.
- Develop, maintain and continually improve templates for process transfer documentation
- Participate in continuous improvement of products and risk mediation
What do we expect?
- Good knowledge of biomanufacturing processes for microbial and mammalian technology
- Good communication skills both verbal and written; excellent team spirit
- Action oriented and driving for results with good organizational skills
- Good problem solving skills, experienced in operations, HSE and technical writing
- Experience with working under GMP - good knowledge of cGMP and FDA requirements for biologics manufacturing, validation and technology transfer requirements
- Experience with technology transfer and scale up, working in multidisciplinary teams
- Experience with disposable and stainless steel equipment desired
- Fluent English
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.