Jobbeschreibung
Octapharma Biopharmaceuticals GmbH was founded in 1997 and is a successful expanding biotech company in Heidelberg, a subsidiary company of the international operating Octapharma group. Our core business is in research and development of recombinant proteins derived from human cell lines. We strive to develop treatments with an improved tolerability for the patient and longer half-lives.
We are seeking to recruit an Associate Expert Bioprocess USP to join the Pilot Plant Upstream Process team starting in January 2025 at our Research and GMP Production Site in Heidelberg.
- Evaluate new and existing bioprocess technologies, methods, and equipment with focus on scale-up and optimization of cell culture
- Plan and carry out independent experiments to support process optimization and development from shake flasks to production bioreactor
- Perform production operations according to GMP and all other applicable quality regulations
- Create and review manufacturing process and other GMP relevant documentation
- Coordinate routine activities that occur in the Pilot Plant; manage daily production schedules
- Coordinate and plan equipment qualification, maintenance activities
- Perform in-depth troubleshooting, as well as deviation investigations
- Close cooperation with Quality Assurance to ensure compliance with GMP requirements
- Degree in Biotechnology/ Chemical Engineering/ related fields (MSc. or PhD a plus)
- Technical knowledge and experience with bioreactors and control systems (e.g. SCADA WinCC, MFCS/win)
- Working experience under GMP cleanroom conditions
- Experience with process development, scale-up and operation of large-scale bioreactors is highly desirable
- Understanding of design of experiments (DoE) and statistical analysis of experimental and characterization data is desirable
- Personal responsibility, autonomous organization skills, and ability to manage time effectively to complete assignments in the allotted time frame
- Very good knowledge of spoken and written English
- Understanding of underlying GMP principles in a way to improve the existing system and apply measures commensurate to the level of risk of the underlying activity
- A permanent position in a dynamically growing company
- Wide range of training opportunities, self-improvement, and further education by attending scientific conferences and workshops
- Work in modern, state-of-the art equipped labs
- Flexible working hours, 30 days of paid annual leave, Job-Ticket
- Cooperative work environment with outside work activities