Process Assessment and Validation Scientist II
Core
Performing process assessments and validation activities for new process implementation and post-Technology Transfer support in a CGT manufacturing facility.
Role type
Senior IC process scientist (CGT manufacturing)
Builds
Validated manufacturing processes for cell and gene therapy medicines
Domain
Life sciences / Cell and Gene Therapy (CGT) / GMP manufacturing
Required skills
CGT manufacturing technologies, GMP standards, aseptic processing, Aseptic Process Simulation (APS), risk evaluation, root-cause investigation, technical troubleshooting
Preferred skills
Process design, facility layout planning, equipment evaluation, materials assessment, continuous improvement initiatives
Technologies
Aseptic Process Simulation (APS)
Responsibilities
Execute process assessment and validation activities; Evaluate process-related areas from a GMP perspective; Monitor and trend performance data during and post-Technology Transfer; Lead root-cause investigations and technical troubleshooting for process deviations
Seniority
Senior, hands-on IC