Research Associate 1, Process Analytics and Services (Analytical Sciences)

About the role

The Analytical Sciences department is seeking a Research Associate 1 to join the Process Analytics & Services (PAS) function. This is a hands-on laboratory role supporting analytical testing and characterization of therapeutic candidates across process development, early clinical, late-stage, and commercial programs.

Responsibilities

• Analytical Testing & Data Execution
• Perform routine and non-routine analytical testing to support process development (Drug Substance and Drug Product) and lifecycle programs
• Execute assays including: Chromatographic methods (e.g., HPLC/UPLC), Capillary electrophoresis (CE) and gel-based electrophoresis (e.g., SDS-PAGE), Spectrophotometric methods (e.g., UV/Vis, FTIR), Plate-based assays (e.g., ELISA) and cell-based bioassays
• Basic nucleic acid and compendial physicochemical testing
• Accurately document test results in accordance with GMP/GLP and internal procedures
• Analyze and interpret analytical data and communicate results clearly
• Method Lifecycle & Laboratory Support
• Support method qualification, optimization, validation, and transfer activities under supervision
• Aid in drafting and updating technical documents (e.g., analytical procedures, protocols, reports)
• Support troubleshooting of analytical methods and laboratory workflows
• Maintain laboratory equipment and ensure readiness of reagents, standards, and materials
• Process Development & Cross-Functional Support
• Provide analytical testing support for process development, manufacturing, and investigation activities
• Collaborate with cross-functional teams including: Drug Substance Technologies (DST), Formulation and Drug Product Technologies (FPT), Manufacturing Sciences & Technology (MSAT), Manufacturing, Quality Control, and Quality teams
• Support in-process, release, and stability-related analytical testing
• Compliance & Inspection Readiness
• Ensure all work is performed in accordance with GxP requirements and BioMarin procedures
• Maintain laboratory documentation and data in an inspection-ready state
• Support regulatory inspections, audits, and site readiness activities
• Data Management & Communication
• Document experimental plans, results, and conclusions clearly and accurately
• Maintain organized electronic records to ensure traceability and data integrity
• Present data and progress updates in team meetings
• Continuous Improvement & Team Support
• Contribute to improvement of laboratory processes, workflows, and documentation practices
• Support training and knowledge sharing within the team as appropriate

Requirements

• Hands-on experience with one or more analytical techniques (e.g., HPLC/UPLC, CE, ELISA, spectrophotometry)
• Basic understanding of GMP/GLP principles and data integrity expectations
• Strong written and oral communication skills
• Strong organizational skills with the ability to manage multiple tasks
• Ability to work independently and collaboratively in a team environment

Preferred Skills

• Hands-on experience with chromatographic (LC/HPLC/UPLC) and capillary electrophoresis (CE) methods
• Exposure to biopharmaceutical development or protein characterization
• Experience with bioassays or cell-based assays
• Familiarity with analytical method lifecycle activities (e.g., qualification, troubleshooting, validation, or transfer)
• Experience working in a cross-functional or fast-paced environment

Education & Experience

• Bachelor’s degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field
• 1–2 years of relevant experience in a pharmaceutical or biotechnology environment
• Master’s degree is a plus but not required

Additional Information

• This is a fully onsite laboratory role
• Routine work includes handling chemicals and biological materials with appropriate safety practices
• May require occasional flexibility to support operational needs