#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 Microbial 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:
- Establish the new microbial facility including chose of production line, participation in engineering activities, supervision of SAT,FAT, IQ/OQ and PQ activities compliant with GMP regulations
- Supervise the technology transfer of internally developed products and for CMO purpose
- Build, lead, develop and motivate the team
- Plan, monitor and improve the production processes and process quality
- Coordinate issue identification and corrective action plans; and implement such plans to resolve project "issues" and maintain business commitments
- Continuously improve process in every aspect compliant with internal and external regulations
- Supervision the process validation
- Represent Polpharma Biologics in business meetings with customers, partners, partnerships/joint development committees and professional societies
- Preparation all necessary process documentation and documentation related to the process performance
- Present the results on internal and external meetings
- Establish all the necessary documentation to run the production and processes in microbial production according to internal quality system and GMP/FDA requirements
- Regular report progress in production, issues, plans and challenges to the superior
If you have:
- Proven track record in the technical development and production of therapeutic proteins in microbial expression systems
- Experience with production scale-up and commercial scale production operations
- Experience with technology transfer
- Experience with stainless steel technology in production
- GMP and FDA experience
- Experience with single-use production equipment and with biosimilars would be an advantage
- Fluency in English, knowledge of the Polish language would be an advantage
- PhD in Biotechnology, Biochemistry or related field
- Strong leadership skills
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