#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:
- Build, train, develop, supervise and manage the Microbial Upstream Team
- Lead GMP production activities within the microbial USP area
- Plan and execute all microbial GMP USP activities in line with facility requirements
- Lead all trouble-shooting activities and deviation assessments in the microbial USP area
- Interact with internal and external collaborators
- Represent microbial GMP USP at project team meetings
- Ensure that all activities comply with appropriate pharmaceutical and biotech regulations e.g. ICH, EMA and FDA
- Support facility and equipment qualification efforts
- Support process transfers and validation activities
- Follow SOPs and GMP requirements
- Prepare process plans
- Control process costs
- Collaborate with Logistics and Procurement to ensure materials’ availability for processes
- Regular reporting of the work status to the supervisor
If you have:
- Bachelor of Science or higher, in Biotechnology or related disciplines
- Supervisory/managerial experience in a biologics environment
- Good knowledge of current GMP standards
- Good communication skills
- Experience with stainless steel line
- Experience of process transfer and validation
- Experience with deviation, CAPA and change control
- Experience with equipment qualification will be an advantage
- Good knowledge of English
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
