Associate Expert Bioprocess USP

Save this Job Save

Octapharma

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.

Don't forget to mention EuroPharmaJobs when applying.

Share this Job