Manager - Analytical Development (Analytics)
Core
Lead a team of scientists to deliver high-quality analytical solutions for synthetic drug products throughout the product lifecycle, supporting CMC, new product development, regulatory submissions, and lifecycle management.
Role type
Manager, Analytical Development (Synthetics)
Builds
Analytical methods, validation protocols, and technical documentation for synthetic pharmaceutical products
Domain
Pharmaceutical R&D, Analytical Chemistry
Required skills
Pharmaceutical analytical development, method development and validation, regulatory compliance (GMP), project management, team leadership, stability strategy, root cause analysis, technical troubleshooting
Preferred skills
Experience with synthetic drug products, digital tools in analytics, global matrix environment navigation
Technologies
HPLC, GC, Mass Spectrometry, Stability testing equipment, LIMS
Responsibilities
Lead analytical development activities for synthetic drug products from development through commercialization; Provide scientific oversight for analytical method development, validation, transfer, and robustness assessments; Lead planning and execution of project deliverables across multiple development programs; Lead, coach, and develop a team of scientists; Ensure compliance with GMP, data integrity, and safety requirements
Seniority
Manager, People Leader
