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Research Associate II, Bioanalytical R&D, Assay Development

BioMarin


Location:
SAN RAFAEL, California 94901
Date:
06/12/2018
2018-06-122018-07-12
Job Type:
Employee
Job Status:
Full Time
BioMarin
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Job Details

The BioAnalytical Sciences (BAS) department is part of BioMarin’s interdisciplinary translational research group that is responsible for scientific analysis and strategy support for BioMarin’s innovative pipeline.  BAS involvement stretches from discovery through clinical development, and includes ongoing support for BioMarin’s six marketed products. BAS team members employ a wide range of technical skills in the analysis of biomarkers, drug concentrations, and immunological activity across all therapeutic programs, interacting with multiple different partners in our drive to address unmet medical needs in rare disease.   BioMarin offers a unique opportunity to contribute broadly to novel therapeutics and rapidly translate the work to real impact on rare disease patients and families. 

 

SUMMARY

BioAnalytical Research and Development (BARD), within BAS, develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-human and human subjects to support projects through multiple stages of development. The Research Associate II (RAII) will design and execute technically complex experiments to support these projects. They will provide quantitative data analysis, interpretation of results, and contribute to technical reports (e.g. assay qualification and validation reports, SOPs). The RA II evaluates complex methods and technologies, identifies new areas requiring process improvement and adapts existing processes or develops new ones with direct input and supervision from a manager. The RAII also evaluates new lab equipment, recommends vendors, and provides assistance to assay development, troubleshooting and validation.  They may contribute to scientific publications and regulatory submissions as required.

 

RESPONSIBILITIES

  • Develop a variety of analytical methods to detect biomarkers, drug, and antibodies to protein therapeutics in biological matrices. Techniques may include (but are not limited to) nucleic acid extraction, reverse transcription (RT), polymerase chain reaction (PCR), enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence assays (ECLA), cell-based and ex vivo culture assays.

  • Qualify selected assays or reagents for transfer to BioAnalytical Testing and validation.

  • Participate in management and oversight of assay development and validation projects outsourced to contract research organizations (CROs).

  • Analyze data, including basic statistical and graphical analysis.

  • Present results, conclusions, and implications to BioAnalytical R&D group.

  • Develop new techniques, or bring in new technology from the outside, to enhance the analytical capabilities of the group.

  • Prepare SOPs and other reports and documents to support nonclinical and clinical programs and associated regulatory submissions. This includes qualification protocols, qualification reports, memoranda, and data reports for testing results.

  • Share responsibility for lab management duties.

  • Participate and present data as a member of BioAnalytical teams, and share responsibility for project milestones.

  • Present data and participate in discussion in Research/ Pharmacological Sciences/Translational Sciences (RPT) team meetings as necessary.

  • Participate in external scientific meetings and contribute to original peer-reviewed publications.

  • Other duties as assigned.

     

    EXPERIENCE

  • 2 - 4+ years experience with assay development and validation.

  • Broad technical proficiency.

  • Ability to solve moderately complex issues independently.

  • Familiar with, or willingness to learn relevant GLP, GCLP, and other FDA guidances.

  • Excellent verbal and written communication skills, including the ability to cogently prepare and present data in group settings, and prepare formal reports.

  • Ability to use computer effectively for data analysis and presentation.

  • Working knowledge of molecular and cell biology and biochemistry.

     

    EDUCATION

  • Bachelor (BS / BA) degree in a biological or biochemical field, with 4+ years experience with biomarker assays, molecular biology assays, immunoassays, and/or other analytical methods.

  • Masters (MS) degree in a biological or biochemical field, with 2+ years experience with biomarker assays, molecular biology assays, immunoassays, and/or other analytical methods.

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