Single Use Process Scientist Role Summary
The Single Use Process Scientist plays a key role in supporting the design, implementation, and operation of single-use technologies for GMP biologics and ADC manufacturing. This position involves conducting gap analysis, facility fit studies, and process safety assessments to ensure seamless operations.
Key Responsibilities:
* Support the development and optimization of single-use process steps
* Prepare and update specifications, protocols, and batch records
* Set up and operate single-use equipment
* Provide training to manufacturing personnel
* Collaborate with various teams to ensure compliance with GMP and EHS policies
* Support cross-functional initiatives
Requirements:
Strong knowledge of single-use technologies is required, including design of new single-use assemblies. A third-level degree in a relevant engineering, science, or technical discipline is necessary, along with at least 3 years' experience in GMP pharmaceutical or biologics environments.
Desirable Skills:
* Experience with single-use systems
* ADC manufacturing expertise
* Knowledge of cleaning study design