#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 managing the Bioassay Team in the Quality Control department. Your team's accountabilities will include preparation and performance of biological tests as well as preparation of documentation related to the activities of the team. You will also deliver appropriate trainings for your team members and take care of budget planning.
- QC Bioassays Team management, motivating employees towards achieving of the set objectives
- Approval of specifications, sampling instructions, test methods and other biological procedures in Quality Control department
- Preparation, review and approval of protocols, reports, methods, procedures, instructions and other Quality Control documents
- Ensuring the performance of all necessary biological analysis and evaluation of records
- Timely and reliable performance of analyses
- Responsibility for Certificates of Analyses
- Ensuring performance of appropriate validation of pharmacopeial methods
- Ensuring maintenance and qualification of premises and equipment in the department
- Providing introductory and other trainings according to employees’ needs
- Participation in internal and external audits
- Performing all the duties according to current GMP requirements and other pharmaceutical regulations
- Selection of and cooperation with contract laboratories
- Supervision of the quality records
- Preparation of the annual budget of Quality Control Bioassay based on production plans
- Planning of subordinates’ employees work and progress reporting
- Practical and theoretical knowledge of performance, validation and transfers of biological, analytical methods (e.g. ELISA) used for in-process control and final product testing of biopharmaceutical manufacturing
- University degree (Chemistry, Biotechnology, Molecular Biology, Biochemistry, Pharmacy, Medicine or related)
- Min. 5 years of experience in regulated laboratory environment (biotech lab preferably)
- Very good knowledge of cGMP and GDP rules, ability to implement them and supervise compliance with them
- Very good knowledge of FDA/EMA regulations in reference to bioanalytical methods
- Fluent English
- Organizational skills, ability to work under time pressure
- Teamwork skills
- Problem solving skills
- Analytical thinking ability
- Good knowledge of MS Office
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
