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Research Associate, BioAnalytical Testing I (TEMPORARY)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

Duties


BioAnalytical Sciences develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-clinical and clinical subjects to support projects through multiple stages of development. The Research Associate I will perform bioanalysis, using validated PK or immunoassay methods, on non-clinical and clinical samples in a GLP compliant environment. Responsibilities can include sample preparation, sample analysis, GLP documentation, report generation, assay validation and troubleshooting, and interaction with BioMarin’s GLP quality assurance unit.



Responsibilities: 



    • Perform quantitative and semi-quantitative assays on non-clinical and clinical samples such as but not limited to serum, plasma, and urine, including immunoassays (ELISA) for therapeutic protein concentration and antibodies to therapeutic proteins, enzymatic activity assays, and glycosaminoglycans determinations.

    • Assist in assay development and qualifcation of new test methods.

    • Prepare SOPs, reports and documents such as assay validation, qualification and maintenance reports.

    • Independently perform routine tasks with minimal supervision

    • Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.

    • Participate in internal and external inspections/audits. 


Scope: 


Responsible for efficient and effective laboratory operations, the Research Associate I has a significant impact on the company's ability to reach project goals in a timely manner with respect to delivery of data to support pre-clinical and clinical studies critical to advancing programs through the development process.



Work Environment/Physical Demands:


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 


While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.


 The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.



Skills



    • Required: At least 0-2 years of experience in a bioanalytical laboratory, research laboratory, or biotechnology company performing bioanalytical assays.

    • Preferred: Skills with ELISA and other analytical methods in a GLP-compliant environment, or equivalent analytical experience in a regulated lab environment

    • Preferred: Experience with GLP or GMP documentation and testing.

    • Preferred: Experience with Meso Scale Discovery (MD) and Molecular Devices plate readers

    • Preferred: Experience with Watson LIMS, statistical analysis software, JMP and ELN.

    • Preferred: Excellent writing and verbal communications skills.

Education


Preferred: Bachelor’s degree or equivalent experience with clinical assays or other quantitative analytical methods in a biological or biochemical field.

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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