#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
As a USP Microbial Plant Manager you will be responsible for leading a microbial USP production team of shift leaders, process specialists, documentation specialists and operators being responsible for USP part of the drug substance manufacturing. You will work in a cGMP environment, overseeing daily operations in state of the art facility, working with passionate and enthusiastic team.
- Manage a team of specialists and operators within the microbial production upstream team
- Deliver materials for DSP production team
- Keep the USP facility and equipment compliant with GMP
- Establish all necessary documentation to run the production and processes in microbial production according to internal quality system and GMP/FDA requirements
- Support process transfers and validation activities
- Participate in troubleshooting during technical transfer, scale-up, validation and routine production
- Coordinate issue identification and corrective action plans & implement such plans to resolve project "issues" and maintain business commitments
- Regularly present data on project meetings and internal team meetings, summarize data and deliver it to the MS&T team
- Develop and motivate the team
- Maintain high work efficiency and keep accurate records
- 5 years of experience in GMP production environment with direct involvement in USP of microbial process
- Extensive knowledge of microbial cultivation and primary recovery processes, as well as of scale-up/scale-down techniques
- Knowledge of cGMP regulations
- Experience with GMP inspection, FDA inspection will be an asset
- Experience with stainless steel technology in production
- Experience with CIP of production equipment
- Knowledge and understanding of process, equipment and systems to troubleshoot problems and provide solutions
- Ability to work efficiently under time pressure with multiple task simultaneously to meet timelines and goals
- Fluency in English, knowledge of the Polish language will be of advantage
- Strong leadership and people development skills combined with good communication skills
- Good learner with flexible attitude to work
- Bachelor’s, Master’s or PhD degree in Biotechnology, Biochemistry, Life Technologies or related field)
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com