Scientist III - Continuous Process Verification
Core
Establish global Continued Process Verification (CPV) initiatives, standard practices, and statistical support for biopharmaceutical manufacturing validation.
Role type
Senior IC biostatistician / CPV engineer
Builds
Commercial customer programs in biologics manufacturing
Domain
Biopharmaceuticals / Bioprocessing
Deliverable
production ML models | dashboards & analysis
Required skills
CPV, process validation, biostatistics, DoE studies, JMP, GMP compliance, report drafting
Preferred skills
Master's degree, Ph.D., experience with single-use technology
Technologies
JMP, Microsoft Excel, Microsoft Word
Responsibilities
Establish global CPV initiatives and standard practices; Act as primary biostatistician for Process Engineering and DoE studies; Manage CPV program scope, schedule, and reporting; Draft, review, and approve CPV plans, reports, and APQRs; Participate in Customer and Regulatory Audits.
Seniority
Senior, hands-on IC