#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!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
In this position you will be leading the team of scientists and coordinate the development and characterization of upstream processes in R&D department.
- Recruitment and development of assigned team to be capable of championing technical aspects of upstream process development
- Planning and execution of lab scale studies for development, optimization and characterization of production upstream processes, including establishment and qualification of SDM, process characterization, small scale validation supportive studies
- Coordination and directing of actions of the team to achieve team and project goals
- Reporting work progress during group, project and other meetings
- Reviewing and approving process and project documentation as well as SOPs applying to the USP lab
- Providing technical and scientific coverage for lab-scale and production operations
- Assessing improvement and optimization of the process with regards to technical as well as economic aspects
- Evaluation of external suppliers of media, filters, disposable materials etc. and maintaining knowledge and understanding of new technologies in the field
- Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments
- Ensuring the team, equipment and records/data are compliant with pharmaceutical regulations
- Collaboration with CLD, DSP, Analytical, TechOps, PM, QA/QC, Regulatory, IP and external CDMO clients in order to achieve optimal results
- University degree in Biotechnology or related field (PhD is a plus)
- At least 3 years of experience in USP development in biotech or pharmaceutical industry, including development, optimization and characterization of processes
- At least 1-2 years as a leader/coordinator of scientific or development team with proven ability of successful management of the group and project activities
- Expertise in USP processes and techniques within a mammalian cell culture (ideally CHO) with in-depth understanding of biological and engineering factors affecting performance and quality attributes
- Hands-on experience in handling: various bioreactor systems and scales (ambr™ systems, 1-10L stirred-tank bioreactor, 10L preferably), single use bioreactor (50L is desired), wave bioreactor, cell harvesting, filtration, centrifugation, etc.
- Working knowledge of DoE methodology
- Knowledge of production scale processes and equipment
- Understanding of DSP process and analytical methods used to monitor the processes
- Experience in process scale-up and transfer to/from external clients is a plus
- Excellent communication, organizational and project management skills, ability to think creatively with a proven ability to solve problems
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.