Senior Research Associate, BioAnalytical Sciences (PK, PD, Biomarkers & Immunogenicity Assessments)

Company: Lyten
Location: San Rafael
Posted on: May 7, 2025

Job Description:

Senior Research Associate, BioAnalytical Sciences (PK, PD, Biomarkers & Immunogenicity Assessments)Who We AreBioMarin 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 Worldwide Research And DevelopmentFrom research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.ROLE: Senior Research Associate in BioAnalytical SciencesThe Assay Strategy and Development group within the BioAnalytical Sciences (BAS) Translational Sciences (TS) group generates bioanalytical data to enable the non-clinical and clinical development of therapeutics. The team is responsible for establishing a program assay strategy, developing and characterizing assays, applying a variety of assay platforms as well as evaluating novel technologies, and conducting translational research internally and with partner contract research organizations (CROs). BAS investigates planned and emerging scientific questions in TS that can be experimentally addressed and may involve application of new technology and/or use of exploratory data sets to support program development and strategy.The Senior Research Associate (SRA) is a laboratory-based role at the BioMarin Research Center. The SRA is responsible for performing the development, optimization and characterization of assays with oversight from Senior Scientists. The SRA will test or oversee the testing of non-clinical and clinical samples to enable the development of therapeutic programs. This role conducts laboratory experimentation based on literature protocols and standard operating procedures (SOPs) and shares general laboratory maintenance responsibilities. They may work with CROs or academic collaborators to achieve scientific objectives. All experiments and methods used, raw data, and data analyses are appropriately documented, and results are effectively communicated at team meetings.Detailed ResponsibilitiesAssay Planning, Design, and Development

• Lead the development, characterization and validation of bioanalytical methods to support pharmacokinetic, pharmacodynamic, biomarkers, and immunogenicity assessments and apply appropriate scientific methods to address experimental questions. Techniques may include (but are not limited to) ELISA/ECL, ligand binding assays, polymerase chain reaction (PCR, qPCR, and ddPCR), various Next-generation sequencing (NGS) platforms, cell-based and ex vivo culture assays, enzyme activity assays, surface plasma resonance, cytometry, nucleic acid extraction, ultrasensitive protein, mass spectrometry or oligonucleotide assays.
• Collaborate with lead scientists and project team members to contribute to assay planning efforts.
• Evaluate existing assays and technology and identify opportunities for improvement.
• Review relevant literature and make suggestions for application or troubleshooting.
• Develop new techniques or bring in new technologies to enhance the group's analytical capabilities.
• Apply appropriate scientific methods to address important TS scientific questions that can be experimentally addressed.Laboratory Execution and Documentation
  • Design and conduct laboratory experiments to develop, optimize, characterize, and validate assays and provide decisive data packages.
  • Write and execute procedures and protocols (e.g., SOPs) and note where changes need to be made, as applicable.
  • Perform experiments for assigned program(s) utilizing standard scientific equipment, tools, and techniques (e.g., microscopy, ELISA, PCR, LC-MS, cell culture, etc.); suggest opportunities for adopting or using new / emerging equipment, tools and techniques.
  • Work on a wide range of processes and suggest any opportunities to adapt existing processes.
  • Oversee proper use and maintenance of laboratory equipment.
  • May monitor vendors to develop assays.
  • May support equipment maintenance.
  • Maintain an inspection-ready laboratory.
  • Maintain accurate and up-to-date records of experimental assays, experimental procedures, observations, data, data analysis and conclusions in electronic laboratory notebooks (ELN) and databases.
  • Adhere to laboratory safety protocols, ethical guidelines, and regulatory requirements.Analysis & Presentation of Results
    • Conduct, or contribute to the conduct of, the analysis and interpretation of results and assay troubleshooting.
    • Utilize statistical analyses to demonstrate assay performance, demonstrate testing proficiency and interpret the resulting data.
    • Suggest ideas for the design/development of new experiments and/or assays based on analysis and interpretation.
    • Communicate results through documentation in lab notebooks and presentations and may contribute to the preparation of research reports, study reports, manuscripts, regulatory documents (e.g., IND submissions), publications and presentations to communicate research findings to internal teams, health authorities and external scientific audiences.Scientific Leadership
      • Develop subject matter expertise in a platform or technology and contribute to the broader scientific community.
      • Support and/or participate in collaborations with experts in the broader scientific community and contribute to the development of relevant thought leadership content - publications, manuscripts, procedures, patents, and speaking engagements.Functional / Cross-Functional Participation and Leadership
        • May participate in laboratory safety and process improvement initiatives within BAS, TS, and across RED.
        • May collaborate with other RED laboratories (e.g., Center of Technology, CoTe) to achieve assay and project objectives.Education & Experience:
          • Bachelors with Minimum 4yr experience in industry.
          • Masters with Minimum 2yr experience in industry.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.Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Seniority level
            • Mid-Senior levelEmployment type
              • Full-timeJob function
                • Research, Analyst, and Information Technology
                • Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Keywords: Lyten, San Rafael , Senior Research Associate, BioAnalytical Sciences (PK, PD, Biomarkers & Immunogenicity Assessments), Other , San Rafael, California