Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Head of Microbial Plant
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Head of Microbial Plant
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- 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
What do we expect?
- 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
Poznaj
POLPHARMA S.A.
Odważnie wybiegamy w przyszłość, co sprawia, że jesteśmy czołowym zawodnikiem w obszarze farmacji. Nasz cel - dbanie o zdrowie - realizujemy dzięki wspólnemu działaniu wszystkich naszych zespołów od Produkcji po Sprzedaż. Możesz zostać częścią jednego z nich.