Principal Scientist, Analytical Operations
Core
Strategic oversight and operational execution of cGMP analytical testing for small molecule clinical development programs, ensuring compliance and data integrity.
Role type
Principal Scientist, Analytical Operations (QC Lead)
Builds
Clinical supply and development milestones for small molecule therapies
Domain
Pharmaceutical / Analytical Chemistry / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP analytical testing, small molecule pharmaceutical development, method validation and transfer, regulatory submissions (CMC), external laboratory management, data integrity, root-cause analysis, CAPA, cross-functional collaboration
Preferred skills
Parenterals, medical device, combination products, phase-appropriate QC strategies
Technologies
cGMP, FDA, EMA, ICH regulations
Responsibilities
Define and improve QC strategy for clinical programs; oversee QC testing for raw materials, intermediates, drug substance, and drug product; manage external contract testing laboratories; author CMC sections for regulatory filings; lead investigations and CAPAs; ensure compliance with cGMP and data integrity standards
Seniority
Principal, strategic oversight & hands-on leadership
