Scientist II, Development Operations
Core
Assist with preparation of analytical method validation protocols, method transfer protocols, and specifications for the Development Laboratory; perform bench work to support client projects.
Role type
Scientist II, Development Operations
Builds
Analytical methods, validation reports, and transfer protocols for pharmaceutical clients
Domain
Pharmaceutical / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation, HPLC, dissolution, GC, physical testing, ALCOA documentation, GLP, ICH, FDA compliance, USP/NF, Ph. Eur.
Preferred skills
Empower, NuGenesis, Chemstation, OpenLab
Responsibilities
Prepare technical documents (method validation/transfer protocols, reports, specifications); Provide input on method transfer plans; Document experimental data per ALCOA; Conduct HPLC, dissolution, GC, and physical testing analysis; Report and investigate Out of Specification (OOS) results; Maintain safe working environment.
Seniority
Mid-level, hands-on IC
