#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 Expert
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
Our Manufacturing Sciences & Technology group is looking for a new team member. On this position you will be at the interface between development, production and quality and become the process data expert by thoroughly analyzing, comparing development and manufacturing data and putting it under quality perspective.
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
- Close collaboration with development and production teams for support activities
- Execution of process risk assessments for GMP operations
- Maintenance of 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 or mammalian technology
- Knowledge of analytical methods, process control understanding
- Good communication skills both verbal and written
- Excellent team player spirit
- Action orientation and drive for results with good organizational skills
- Curiosity and attention to details
- Experience with working under GMP - good knowledge of cGMP and FDA requirements for biologics manufacturing, validation and technology transfer requirements
- Experience by working in multidisciplinary teams
- 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