Sr. Manager, Analytical Development GMP Lab
Core
Leads an analytical GMP group for testing development stage pharmaceutical compounds, including stability samples, reference standards, and method validation/qualification/transfer.
Role type
Senior Manager, Analytical Development GMP Lab
Builds
Supports the development and manufacturing of drug substances and drug products
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation and transfer, GMP/GLP/GDP compliance, technical data assessment, regulatory submission support, laboratory operations management, instrument qualification, SOP development, team leadership, cross-functional collaboration
Preferred skills
Management experience, strategic planning, process improvement, audit preparation
Technologies
N/A
Responsibilities
Oversee internal GMP laboratory operations including staffing, scheduling, and budgeting; Implement strategic plans and evaluation criteria; Develop and maintain SOPs for GMP compliance; Manage stability testing programs and method validation/qualification; Lead instrument qualification, calibration, and maintenance programs; Supervise and review work and data from in-sourced personnel; Maintain accurate documentation of laboratory activities; Hire, train, and develop laboratory personnel; Prepare for and participate in internal and external audits and regulatory inspections; Identify and resolve operational issues and implement process improvements
Seniority
Senior, hands-on IC with management responsibilities
