Manager, MSAT Investigations
Core
Lead investigator for complex root cause analysis, CAPAs, and product complaints at a cell therapy manufacturing facility, ensuring audit readiness and regulatory compliance.
Role type
Manager, Manufacturing Science & Technology (MSAT) Investigations
Builds
Safe and compliant cGMP operations for cell therapy manufacturing
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, corrective and preventative actions (CAPAs), cGMP compliance, multi-national biopharmaceutical regulations, impact assessment, product complaint investigation, Annual Product Quality Reviews (APQRs)
Preferred skills
Operational Excellence, Lean Manufacturing, cell therapy/biologics/vaccine manufacturing experience
Technologies
None explicitly stated
Responsibilities
Conduct and manage resolution of complex/multi-functional root cause investigations; Collaborate with Process Engineering, Manufacturing Operations, QA, and QC; Proactively manage progression of investigations and CAPAs to timely closure; Present investigation findings to stakeholders and senior management; Ensure safe and compliant cGMP operations and inspection readiness; Coach and mentor colleagues on Investigation Program fundamentals
Seniority
Manager, hands-on IC with team leadership
