Bioprocess Specialist (m/f/d)
Michael Page
- Luzern
- Befristet
- Vollzeit
- Supporting the introduction of novel and innovative solutions for biologics manufacturing within the facility
- Managing capital requests and sourcing activities
- Qualification of devices and equipment
- Authoring standard operating procedures
- Serving as a subject matter expert (SME) for newly implemented technologies and guiding their integration into routine production
- Authoring protocols and conducting design of experiments to demonstrate the comparability of new technologies with legacy systems
- Demonstrating excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams
- Demonstrating a desire for continuous learning, improvement, and development, while approaching problems from new perspectives
- Providing support for the manufacturing of clinical supply drug substance, including resupply activities
- Operating equipment according to batch records, sampling plans, and standard operating procedures
- Collaborating with Facility Management and internal team members to ensure GMP compliance through routine monitoring, calibration, maintenance, and certifications of responsible equipment devices
- Successfully completed bachelor's and/or master's degree in a relevant field such as Science/Technical
- At least 3 years of experience working in a relevant academic or industry field with project management knowledge
- Technical knowledge in biological drug substance upstream operations, downstream operations, analytical testing, or process development
- Detailed understanding of general principles of equipment qualification
- Experience in cGMP in a sterile, vaccine, bulk, or finished goods pharmaceutical environment.
- Knowledge of design and operation of automated systems
- Proficient verbal and written communication skills in English (B2). Proficiency in German (B1) is desirable
- Ability to think logically and be proactive under pressure
- Ability to work effectively as part of a team and independently
- Internationally operating, dynamic business environment
- Temporary assignment until end of April 2025 with take-over option