Scientist, Analytical Science & Method Transfer
Core
Lead analytical method transfer and validation activities between internal Quality Control labs and external contract manufacturers (CMOs/CDMOs) under GMP conditions.
Role type
Senior IC analytical scientist (method transfer & validation)
Builds
Robust analytical methods for drug substances and products in external manufacturing environments
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production ML models (Incorrect mapping, correcting to: production ML models is not applicable, the deliverable is validated analytical methods and reports)
Deliverable
Validated analytical methods and regulatory documentation (CTD Module 3)
Required skills
Analytical method transfer strategy, HPLC/UPLC, GC, Dissolution, Spectroscopy, OOS/OOT troubleshooting, GMP/ICH compliance, Root cause analysis, CAPA definition, Regulatory submission support
Preferred skills
Experience with global CMOs/CDMOs, Project management in regulated environments
Technologies
HPLC, UPLC, GC, Spectroscopy
Responsibilities
Coordinate method transfer to external CMOs, Perform scientific troubleshooting for analytical deviations, Design and validate methods per ICH guidelines, Review and approve transfer protocols and reports, Support regulatory submissions, Drive root cause analysis and CAPAs
Seniority
Senior, hands-on IC
