#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:
Microbial Plant USP Manager
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 a team of specialists and operators within the microbial production upstream team
- Delivering materials for DSP production team
- Keeping the USP facility and equipment compliant with GMP
- Establishing all necessary documentation to run the production and processes in microbial production according to internal quality system and GMP/FDA requirements
- Supporting process transfers and validation activities
- Participating in troubleshooting during technical transfer, scale-up, validation and routine production
- Coordinating issue identification and corrective action plans & implementing such plans to resolve project "issues" and maintain business commitments
- Regularly presenting data on project meetings and internal team meetings, summarizing data and delivering it to the MS&T team
- Developing and motivating the team
- Maintaining high work efficiency and keeping accurate records
If you have:
- 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 tasks 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)
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