FSP Associate Research Scientist: Analytical Outsourcing
Core
Manage end-to-end testing programs, research specifications, and quality oversight for raw materials and packaging components supporting clinical drug product manufacturing.
Role type
Associate Research Scientist (Analytical Outsourcing)
Builds
Quality assurance and testing governance for clinical manufacturing supply chain
Domain
Life Sciences / Clinical Research / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, raw material testing oversight, research specification lifecycle management, vendor governance, ANSI sampling plans, regulatory documentation, stakeholder management
Preferred skills
Clinical-stage drug product manufacturing support, external contract testing organization oversight, eQMS/LIMS/ERP platforms, risk assessment methodologies
Technologies
Infinity, SharePoint, Power BI, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Responsibilities
Author and maintain research specifications for raw materials and packaging components; Coordinate qualification and testing of raw materials and packaging components; Manage vendor performance through KPIs and business reviews; Ensure compliance with GMP, data integrity, and regulatory expectations; Create Change Management and Deviation records for testing failures; Lead routine governance meetings with testing vendors
Seniority
Mid-level, hands-on IC