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

DescriptionWho 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. SUMMARYThe 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.KEY RESPONSIBILITIESAnalytical Testing & Data ExecutionPerform routine and non-routine analytical testing to support process development (Drug Substance and Drug Product) and lifecycle programsExecute 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 bioassaysBasic nucleic acid and compendial physicochemical testingAccurately document test results in accordance with GMP/GLP and internal proceduresAnalyze and interpret analytical data and communicate results clearlyMethod Lifecycle & Laboratory SupportSupport method qualification, optimization, validation, and transfer activities under supervisionAssist with drafting and updating technical documents (e.g., analytical procedures, protocols, reports)Support troubleshooting of analytical methods and laboratory workflowsMaintain laboratory equipment and ensure readiness of reagents, standards, and materialsProcess Development & Cross-Functional SupportProvide analytical testing support for process development, manufacturing, and investigation activitiesCollaborate with cross-functional teams including:Drug Substance Technologies (DST)Formulation and Drug Product Technologies (FPT)Manufacturing Sciences & Technology (MSAT)Manufacturing, Quality Control, and Quality teamsSupport in-process, release, and stability-related analytical testingCompliance & Inspection ReadinessEnsure all work is performed in accordance with GxP requirements and BioMarin proceduresMaintain laboratory documentation and data in an inspection-ready stateSupport regulatory inspections, audits, and site readiness activitiesData Management & CommunicationDocument experimental plans, results, and conclusions clearly and accuratelyMaintain organized electronic records to ensure traceability and data integrityPresent data and progress updates in team meetingsContinuous Improvement & Team SupportContribute to improvement of laboratory processes, workflows, and documentation practicesSupport training and knowledge sharing within the team as appropriateREQUIRED SKILLSHands-on experience with one or more analytical techniques (e.g., HPLC/UPLC, CE, ELISA, spectrophotometry)Basic understanding of GMP/GLP principles and data integrity expectationsAbility to analyze and interpret dataStrong written and oral communication skillsStrong organizational skills with the ability to manage multiple tasksAbility to work independently and collaboratively in a team environmentPREFERRED SKILLSHands-on experience with chromatographic (LC/HPLC/UPLC) and capillary electrophoresis (CE) methodsExposure to biopharmaceutical development or protein characterizationExperience with bioassays or cell-based assaysFamiliarity with analytical method lifecycle activities (e.g., qualification, troubleshooting, validation, or transfer)Experience working in a cross-functional or fast-paced environmentEDUCATION & EXPERIENCEBachelor’s degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field1–2 years of relevant experience in a pharmaceutical or biotechnology environmentMaster’s degree is a plus but not requiredADDITIONAL INFORMATIONThis is a fully onsite laboratory roleRoutine work includes handling chemicals and biological materials with appropriate safety practicesMay require occasional flexibility to support operational needsEQUIPMENTOperation of standard laboratory equipment for biochemistry and for cellular assaysREPORTING STRUCTUREReports to: Sr. Manager, Process Analytics & ServicesNo supervisory responsibilitiesWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.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.