#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:
Head of Cell Culture Plant
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:
- Managing and supervision of the team
- Supervision of technology transfer of processes to the cell culture plant for internal and CMO purposes
- Monitor the production processes and process quality, and make improvements as needed
- Coordinate issue identification and corrective action plans and implement such plans to resolve project "issues" and maintain business
- Continuously improve process in every aspect compliant with internal and external regulations
- Planning and Supervision of Process validation
- Representation of Polpharma in business meeting with customer, partners, partnerships/joint development committees and professional societies
- Regular reporting of progress in production, issues, plans and challenges to the superior
- Representing the company during inspection of Cell culture plant
- Process planning
- Presentation of results on internal and external meetings
- Establishment of documentation necessary to run production and processes in microbial production according to internal quality system and GMP/FDA requirements
- Performing all duties with respect to current GMP requirements and other pharmaceutical regulations.
If you have:
- Proven track record in production of therapeutic proteins in mammalian expression systems
- Experience with process transfer and scale-up
- Experience with single use technology
- Experience with European and FDA inspection
- Proven track record of participation in GMP inspection
- Experience with Biosimilars of advantage
- Fluency in English, knowledge of the Polish language of advantage
- PhD in Biotechnology, Biochemistry or related field of advantage
- Strong leader and developer of people
- Knowledge about regulatory requirement for biosimilar products would be advantage
- Experience in single use materials usage for biopharmaceutical production
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