Director, Quality Analytical Support
Core
Provide operational leadership and technical oversight to a team of analytical SMEs supporting West Point laboratory operations, ensuring compliance with cGMP/GLP standards.
Role type
Director, Quality Analytical Support
Builds
Robust, right-first-time execution of analytical testing and laboratory operations for biologics/vaccines/pharmaceuticals
Domain
Pharmaceutical/Biologics Manufacturing (cGMP/GLP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People Leadership, Change Control Management, Chemical Analysis, Microbiological Analysis, Technical Investigation, Troubleshooting, Workload Management, Root Cause Identification, Supervision, Talent Development, Workflow Optimization
Preferred skills
Lean methodologies, Continuous improvement frameworks
Technologies
MPS production systems, Automated laboratory systems, Chromatography/Separations, Biochemistry
Responsibilities
Lead, coach, and mentor a team of analytical scientists; Manage team capacity and prioritize tasks; Oversee technical onboarding and training; Utilize production systems to optimize workflows; Lead tier governance meetings; Manage technical change controls and method updates; Guide troubleshooting of complex analytical methods; Oversee quality investigations and CAPAs; Act as key resource during regulatory inspections; Ensure safety risk assessments are integrated into technical decisions.
Seniority
Director, strategic leadership & hands-on technical oversight
