Principal Scientist, Analytical Operations
Core
Lead Quality Control (QC) operations and strategy for small molecule clinical development programs, ensuring cGMP compliance and regulatory readiness.
Role type
Principal Scientist, Analytical Operations (QC Lead)
Builds
cGMP-compliant clinical supplies and regulatory submissions for small molecule therapies
Domain
Pharmaceutical / Analytical Chemistry / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP operations, analytical chemistry, method validation and transfer, regulatory strategy, data integrity, external lab management, CMC documentation, risk assessment, cross-functional collaboration
Preferred skills
medical devices, combination products
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; lead investigations and root-cause analysis; draft and review CMC sections for regulatory filings; ensure compliance with cGMP and data integrity standards
Seniority
Principal, strategic oversight & hands-on leadership
