#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
The Process Support Team Leader is responsible for participation in the production process of biotechnology products in accordance with the GMP principles and FDA requirements to obtain a product of the specified quality in the specification for registration. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of internal and external biotechnology products. Managing of Operator's work during the shift.
- Participation in the design process, implementation of the production area,
- Responsibility for the purchase, qualification of production equipment,
- Experienced in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products,
- Elaboration of SOPs and manuals ( including manuals to equipment),
- Running and monitoring the dispensing of raw materials and solution preparation process of media and buffer according to GMP requirements, technological documentation and other internal requirements,
- Writing Completion and Review of cGMP paperwork, (SOPs, production documentation),
- Attending of process validation in cooperation with Research and Development Department/ Client,
- Organizing your and team's work in order to make the most effective use of working time and performance of tasks,
- Leads the shift group and responsible of team members.
- Higher education (at least Msc) in Biotechnology, Pharmacy or similar,
- At least 5 year experience in biotechnological or pharmaceutical industry
- Good knowledge of cGMP and FDA requirements,
- Experience in keeping and review process documentation and project documentation according to GMP requirements,
- Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage,
- Experience with dispensing, solution preparation processes
- Experience with material flow
- Experience with sterilization process, SIP and CIP
- Good speaking and writing English skills,
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required,
- Knowledge of MS Office and AutoCAD.
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
