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

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

The selected candidate will execute a variety of GxP and non-GxP analytical methods to support drug substance and drug product process development, method lifecycle activities, and cross-functional technical investigations.

This role requires strong laboratory execution, data analysis, and collaboration skills in a fast-paced, multi-disciplinary environment.

• 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

• Support method qualification, optimization, validation, and transfer activities under supervision
• Assist with 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

• Provide analytical testing support for process development, manufacturing, and investigation activities
• Collaborate with cross-functional teams including:

• Formulation and Drug Product Technologies (FPT)

• Manufacturing, Quality Control, and Quality teams
• Support in-process, release, and stability-related analytical testing

• 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

• 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

• Contribute to improvement of laboratory processes, workflows, and documentation practices
• Support training and knowledge sharing within the team as appropriate

• 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

• 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

• 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

• 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

• Reports to: Sr. Manager, Process Analytics & Services
• No supervisory responsibilities

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position.

It is intended to describe the general nature of the job that may include other duties as assumed or assigned.