Supervisor, Chemistry and Stability
Core
Supervise daily activities in Chemistry and Stability Departments to ensure testing, release, and results reporting of materials, products, and components meet quality, regulatory, and customer requirements.
Role type
Supervisor, Chemistry and Stability
Builds
Stability data and regulatory submissions for pharmaceutical products
Domain
Pharmaceutical manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, stability testing protocols, regulatory submissions, material change request assessment, stability chamber management, statistical analysis, personnel management, budget management, audit response preparation
Preferred skills
Statistical analysis for shelf-life determination, leadership in dynamic environments, problem-solving for analytical results
Technologies
Stability chambers, Quality Management Systems
Responsibilities
Coordinate training and development of department personnel; Prioritize and track daily activities for timely release of materials; Assure staff conformance with cGMP and company procedures; Facilitate investigations for non-conforming materials; Provide technical guidance on processes and products; Compile information for Management Reviews and Audit Responses; Review Stability Testing Protocols and regulatory submissions; Assess impact of Material Change Requests; Manage approving, expiry calculation, and archiving processes; Report department metrics for Quality Management; Assume area ownership of stability chambers and investigate excursions; Review and manage regulatory annual reports.
Seniority
Mid-level Supervisor, hands-on management
