Principal Specialist, Data Review – Analytical Method Development
Core
Independently review analytical method development data, protocols, and reports to ensure accuracy, completeness, and scientific soundness for client expectations and regulatory compliance.
Role type
Principal Specialist, Data Review – Analytical Method Development
Builds
Analytical testing services for food, environment, pharmaceutical products, and agroscience clients
Domain
Life sciences / Pharmaceutical / Analytical Chemistry
Deliverable
client delivery
Required skills
HPLC, GC, IC, mass spectrometry, chromatographic method principles, data interpretation, regulatory guidelines (ICH, GMP), data integrity (ALCOA+), LIMS, ELN, Empower, Mass Hunter
Preferred skills
None stated
Technologies
LIMS, ELN, Empower, Mass Hunter
Responsibilities
Review analytical method development data, protocols, and reports; Evaluate chromatographic method development strategies and data interpretation; Verify analytical data including chromatographic outputs and calculations; Identify discrepancies and drive resolution with stakeholders; Partner with Analytical Scientists and Project Group Leaders; Provide technical insight and clarification to clients; Serve as a technical resource for junior reviewers; Contribute to development of review procedures and training materials
Seniority
Principal, hands-on IC with mentorship