Senior Principal Scientist, Analytical Chemistry
Core
Lead analytical strategy development and establish control strategies to ensure safety, quality, and efficacy of life-saving medicines across all stages of pharmaceutical and biopharmaceutical product development.
Role type
Senior Principal Scientist, CMC Analytical Lead (Individual Contributor)
Builds
Analytical strategies, methods, specifications, and control strategies for drug substance and drug product.
Domain
Pharmaceutical/Biopharmaceutical industry, Analytical Chemistry, CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Synthetic chemistry, analytical method development, validation, technical transfer, GMP/GLP compliance, risk assessment, regulatory submissions, commercialization of small molecule/biologics/ADC, external lab management
Preferred skills
Quality by Design (QbD) principles, modern laboratory equipment and automation, matrixed team environments
Technologies
HPLC, LC-MS, dissolution testing, biopharmaceutical assessment tools
Responsibilities
Lead analytical strategy development as a core member of cross-functional CMC teams; Define product critical quality attributes and establish methods, specifications, and analytical control strategies; Collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions; Review, interpret, and communicate analytical results and conclusions; Author, review, and approve technical reports to support regulatory submissions; Respond to regulatory authority questions related to analytical strategy and data; Provide leadership, coaching, and mentoring to scientific staff within matrix teams.
Seniority
Senior, hands-on IC with strategic influence
