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

About the role

BioMarin is a global biotechnology company that develops transformative medicines for genetic conditions. The Research Associate 1, Process Analytics and Services (Analytical Sciences) will execute various analytical tests to support process development and lifecycle 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
• Ability to analyze and interpret data
• 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

Priorities

• 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

Qualifications

• 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