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
Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams
Demonstrate 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
Qualifications:
A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) is desirable.
At least 3 years of experience working in a relevant academic or industry field.
Technical knowledge in biologics 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, such as DeltaV.
Project management knowledge.
Proficient verbal and written communication skills in English (B2). Proficiency in German (B1) is desirable.