Barrington James · 5 hours ago
Senior Analytical Development Scientist
Tennessee, United States
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expBarrington James is supporting an FDA-registered 503B outsourcing facility in Tennessee that is seeking a Senior Analytical Development / Method Transfer Lead. The role involves leading and executing outsourced-to-in-house analytical method transfer activities to establish a compliant, inspection-ready GMP QC framework.
Health CareRecruiting
Hiring Manager
Ethan Dumoulin
Responsibilities
Lead and execute outsourced-to-in-house analytical method transfer activities, including:
Transfer of analytical and release methods from CROs or external laboratories into internal GMP QC
Authoring and executing method transfer protocols, reports, and acceptance criteria
Assessing method suitability, robustness, and comparability during transfer
Identifying gaps in externally generated methods and defining remediation or refinement strategies
Establishing GMP-compliant documentation and long-term method ownership
Supporting FDA inspection readiness related to analytical controls and release testing
Partnering with QA on deviations, CAPAs, and inspection responses tied to transferred methods
Serving as the technical owner for analytical methods post-transfer
Coordinating closely with Operations, QC, QA, and external labs during transition
Qualification
Required
10+ years of hands-on GMP analytical experience in pharmaceutical or biotech manufacturing environments
Proven experience independently leading analytical method transfer from outsourced or external labs into in-house GMP QC
Strong documentation authorship experience, including protocols, reports, and regulatory-facing records
Background in analytical development combined with GMP QC method ownership
Experience operating in 503B, CDMO, or highly regulated manufacturing environments
Demonstrated ability to make and defend risk-based technical decisions with QA and regulators
Prior exposure to FDA inspections or audits where analytical methods were in scope
Ability to work onsite or hybrid in Tennessee during critical phases of the project
Preferred
Experience with dissolution or release testing for solid or implantable dosage forms strongly preferred
Company
Barrington James
Barrington James has a true global reach, with its international HQ in London-Gatwick, continental hubs in Singapore.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Orangewood Partners
2022-10-05Private Equity
Recent News
2022-10-14
2022-10-06
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