#PolpharmaBiologics 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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
WE ARE LOOKING FOR:
MS&T Process Lead
Gdańsk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Collecting and reviewing process information, data, analytical methods and perform process risk assessments / GAP analysis on processes transferred from internal or external parties
- Generation of accurate tech transfer plans and protocols in close collaboration with development and production teams
- Coordination and execution of process risk assessments for scale-up operations and transfer to large scale production
- Development, maintenance and continue improvement of templates for process transfer documentation
- Participation in continuous improvement of products and risk mediation.
- Preparation for process validation including relevant risk assessments
- Generation of validation Master Plan, validation protocols and reports
If you have:
- Good knowledge of biomanufacturing processes for microbial and mammalian technology
- Good communication skills both verbal and written
- Excellent team player spirit
- Action orientation and drive for results with good organizational skills
- Good problem solving skills, are 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
- Ideally experience with process validation according to FDA and EMEA guidelines
- Experience with disposable and stainless steel equipment desired
- Fluent English
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
