Senior Manager, Analytical Sciences - Commercial
Core
Senior Manager leading analytical activities for commercial small molecule drug products at CDMOs, ensuring compliance, supply continuity, and lifecycle management.
Role type
Senior Manager, Analytical Sciences (Commercial)
Builds
Commercial manufacturing testing, product release, and supply continuity for approved small molecule drugs
Domain
Biopharmaceuticals / Small molecule drug substance and product / CDMO operations
Required skills
Analytical method transfer, validation, lifecycle management, OOS/OOT investigation, regulatory compliance (cGMP, ICH), CDMO management, data review (ALCOA+, 21 CFR Part 11), technical reporting (APR/PQR)
Preferred skills
Analytical development experience, direct FDA/EMA inspection support experience, knowledge of solid oral and liquid/reconstituted products
Technologies
HPLC, GC, Chromatographic integrations, LIMS, Electronic audit trails (via careerplan.io/jobs/5233449008-senior-manager-analytical-sciences-commercial-at-praxisprecisionmedicines)
Responsibilities
Define and execute analytical strategies for commercial products; Lead method transfer, validation, and lifecycle management; Provide analytical leadership for PPQ, CPV, and stability programs; Review and approve analytical documentation; Oversee analytical execution at CDMOs; Lead analytical investigations (OOS/OOT, deviations, CAPAs); Assess analytical risks and impurity controls; Author technical reports and regulatory submissions.
Seniority
Senior Manager, hands-on leadership