Senior Project Manager - Pharma R&D
Core
Leading analytical activities and coordinating CMC projects in early and late-phase drug development.
Role type
Senior Analytical Leader (Pharma R&D)
Builds
New medicines (small molecules, various galenic forms)
Domain
Pharmaceutical R&D / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry development, CMC project lifecycle management, regulatory guidelines (IMPD, IND, Module 3), chromatography, dissolution, method validation, method development, data analysis, stakeholder coordination, international subcontractor management
Preferred skills
Outsourcing experience, ASO knowledge
Technologies
Chromatography, dissolution equipment, validation software
Responsibilities
Participate in early and late-phase analytical development projects, serve as the primary analytical contact for CMC project teams, design and coordinate internal and outsourced analytical studies, centralize and analyze data for regulatory submissions, ensure data quality and compliance with standards, interact with internal labs, partner sites, international subcontractors, and regulatory affairs.
Seniority
Senior, hands-on IC with strategic oversight
