Senior Manager, Drug Product Analytics
Core
Lead a team of analytical scientists to support Pfizer's small-molecule portfolio from early development through commercialization, defining analytical strategies and ensuring robust deliverables aligned with regulatory expectations.
Role type
Senior Manager, Drug Product Analytics
Builds
Analytical development programs, control strategies, and regulatory submissions for small-molecule drug products
Domain
Pharmaceutical industry, Drug Product Development, CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> regulatory submissions and analytical control strategies
Required skills
Team leadership and coaching, strategic analytical development, regulatory submission leadership, cross-functional CMC collaboration, CRO/CMO oversight, project planning and risk mitigation, stakeholder influence
Preferred skills
Formulation and process development knowledge, multi-modality experience (peptides, drug-linkers), digital tools and automation application, scientific initiative advancement
Technologies
CRO/CMO management platforms, digital tools for analytical development, modeling and simulation tools
Responsibilities
Lead and develop a team of analytical scientists; Provide strategic leadership for analytical development and control strategies; Serve as analytical lead in multidisciplinary CMC teams; Lead regulatory submission activities; Manage analytical activities executed through external partners; Establish and execute analytical project plans; Build partnerships across Drug Product Development, Supply, Regulatory, and Quality organizations
Seniority
Senior Manager, hands-on leadership with strategic oversight