MSAT Process Science Senior Scientist, Investigations
Core
Leading complex technical investigations and driving strategic process improvements in manufacturing operations using Six Sigma and statistical methods.
Role type
Senior Scientist (Process Science, Investigations)
Builds
Robust root cause analysis, effective CAPAs, and sustainable process improvements aligned with regulatory expectations.
Domain
Biopharmaceutical manufacturing (cell and gene therapy, biologics)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Six Sigma (DMAIC), statistical analysis, multivariate data analysis, cGMP regulations, CMC submissions, cross-functional collaboration, technical reporting
Preferred skills
Lean Six Sigma certification, advanced analytics, technology transfer, scale-up, process validation
Technologies
JMP, Statistica
Responsibilities
Lead high-impact technical investigations and root cause analysis; Act as SME for deviations, OOS, and OOT; Develop investigation reports for leadership and regulators; Lead strategic improvement projects to reduce variability and increase yield; Collaborate with cross-functional teams to implement continuous improvement initiatives.
Seniority
Senior, hands-on IC