Reference Standard Scientist - Client - dedicated
Core
Lead management and oversight of Reference Standards (RS) for small molecule drug substances and products, ensuring compliance with GMP and regulatory requirements to support clinical and commercial data integrity.
Role type
Reference Standard Scientist (Client-facing)
Builds
Reference materials (Primary, Working, Development Standards) and Certificates of Analysis for pharmaceutical/biopharmaceutical clients
Domain
Pharmaceutical/Biopharmaceutical industry, Analytical Services
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, inventory management, technical writing, data integrity, project coordination, regulatory inspection support, LIMS usage, separation science knowledge
Preferred skills
Digital tools for inventory management, digital tools for data reporting
Technologies
LIMS systems, technical operating systems
Responsibilities
Coordinate testing and documentation of characterisation, qualification, and stability of Reference Materials; Manage inventory and coordinate distribution of reference materials; Establish partnerships with Global Supply Chain, Quality, and Third parties; Coordinate transfer of R&D reference materials to commercial groups; Prepare and support internal/external regulatory inspections; Draft Certificates of Analysis; Resolve technical and operational problems for reference materials
Seniority
Mid-level, hands-on IC