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

BioMarin Pharmaceutical Inc.•Novato, CA

62d•Onsite

About The Position

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. 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.

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
Bachelor’s degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field
1–2 years of relevant experience in a pharmaceutical or biotechnology environment

Nice To Haves

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
Master’s degree is a plus but not required

Responsibilities

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: 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
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