#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 DSP Process Lead (Mammalian production)
Gdansk 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 related to DSP process operations
- Generation of accurate tech transfer plans and DSP protocols in close collaboration with development and production teams
- Coordination and execution of DSP process risk assessments for scale-up operations and transfer to large scale production
- Development, maintenance and continue improvement of templates for DSP process transfer documentation
- Participation in continuous improvement of products and risk mediation
- Providing technical input into deviation investigations, CAPA implementations and change controls
- Preparation for DSP process validation including relevant risk assessments
- Generation of validation Master Plan, DSP validation protocols and reports
- Participation in Virus Clearance studies
If you have:
- Higher education
- 5 years of experience in biotechnological industry at production or laboratory scale
- Excellent understanding of DSP technologies for monoclonal antibodies, recombinant proteins
- Good knowledge of biomanufacturing processes for mammalian technology
- 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
- Good problem solving skills, are experienced in operations, HSE and technical writing
- Fluent English
- Good communication skills both verbal and written
- Action orientation and drive for results with good organizational skills
- Ideally experience with process validation according to FDA and EMEA guidelines
- Experience in virus clearance studies will be an additional advantage
- Experience in single use materials usage for biopharmaceutical production will be an additional advantage
- Understanding of quality control for biologics and analytical method development would be of benefit
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
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
