Manager, Analytical Sciences - Commercial
Core
Manager leading analytical strategy, method transfer, validation, and lifecycle management for commercial small molecule drug products in partnership with CDMOs.
Role type
Manager, Analytical Sciences (Commercial)
Builds
Compliant commercial manufacturing supply chain and regulatory readiness for approved small molecule drugs
Domain
Biopharmaceuticals / Small molecule drug substance and product / CDMO management
Required skills
Analytical chemistry, GMP compliance, method validation, lifecycle management, OOS/OOT investigation, regulatory submissions, CDMO oversight, data integrity (ALCOA+), risk assessment
Preferred skills
Commercial small molecule experience, analytical development, health authority inspection support, post-approval changes (via careerplan.io/jobs/5233455008-manager-analytical-sciences-commercial-at-praxisprecisionmedicines)
Technologies
HPLC, GC, LC-MS, Chromatographic integration systems, LIMS, Electronic audit trails
Responsibilities
Execute analytical strategies for commercial products; Lead method transfer and validation; Support PPQ, CPV, and stability programs; Review and approve analytical documentation; Manage CDMO analytical activities; Lead analytical investigations (OOS/OOT, deviations, CAPAs); Assess analytical risks for manufacturing and supply chain changes; Contribute to regulatory submissions and health authority responses.
Seniority
Manager, hands-on IC with strategic oversight