Analytical Scientist, GxP Method Validation & Transfer

BioSpace; Novato (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioMarin is seeking a Research Associate for our onsite Analytical Services team in the Analytical Sciences group. The role focuses on advancing BioMarin’s therapeutics through rigorous GxP testing of early clinical programs and transitions to late-stage development, with emphasis on method qualification, validation, and transfer.

You will work under limited supervision to ensure phase-appropriate performance, troubleshoot, optimize, validate, and transfer analytical methods for drug substance

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or related field with 2–4 years in a biologics or pharmaceutical environment.
• Master’s degree desirable but not required.
• Experience with GMP/GLP and GxP testing.
• Onsite laboratory role with hazardous materials awareness.

Responsibilities

• Lead and perform analytical testing (HPLC/UPLC, electrophoresis, UV, ELISAs, cell-based bioassays).
• Draft and review analytical procedures, method validation protocols/reports, transfer protocols/reports.
• Manage validation and transfer of QC methods to internal and external labs.
• Lead investigations to identify root causes and implement CAPAs.
• Provide SME support for analytical methods and equipment maintenance.
• Support regulatory inspections and audits.

Skills

HPLC/UPLC

GMP/GLP

Data analysis

Communication

Project coordination

Education

Bachelor's in Chemistry/Analytical

Master’s desirable

Tools

LIMS

ELN

HPLC instruments

Job description

BioMarin is seeking a Research Associate for our onsite Analytical Services team in the Analytical Sciences group. The role focuses on advancing BioMarin’s therapeutics through rigorous GxP testing of early clinical programs and transitions to late-stage development, with emphasis on method qualification, validation, and transfer.

You will work under limited supervision to ensure phase-appropriate performance, troubleshoot, optimize, validate, and transfer analytical methods for drug substance