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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.
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.
Responsible for efficient and effective laboratory operations, the Research Associate I has a significatn 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.
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.
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