Research Associate 2Location San Rafael, California Apply
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.
The Research Associate II, Testing, manages, coordinates, and performs activities required for the testing of human and animal specimens associated with one or more clinical or non-clinical studies in accordance with GLP requirements. Responsibilities can include sample preparation, sample analysis, GLP documentation, report generation, assay validation and troubleshooting, and interaction with BioMarin’s GLP quality assurance unit. Duties include training of associates, working independently to troubleshoot instruments and assays, and presenting scientific data to colleagues and sub-teams. May oversee/coordinate testing and lab operations schedule and activities for associates.
- Characterize, validate and troubleshoot new test methods, as needed, to reach company milestones.
- Contribute to assay development if required by project timeline.
- Independently perform quantitative and semi-quantitative assays on non-clinical and clinical samples such as but not limited to serum, plasma, and urine, including immunoassays for therapeutic protein concentration and antibodies to therapeutic proteins and enzymatic activity assays.
- With minimal guidance, design experiments and analyze data for qualification, validation and troubleshooting of analytical methods.
- Independently prepare data reports, deviation reports, Change Requests, assay SOPs. Revise and review process SOPs and departmental forms, prepare validation reports using standardized templates, give presentations as needed.
- Interact with assay developers, collaborators, and contract organizations, as necessary, to ensure successful assay transfers, appropriate sample analysis and resolutions of observations.
- Operate within project schedule to ensure timely transmission of data to study teams.
- Carry out GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Participate in internal and external inspections and audits, including preparation and execution of corrective actions for observations noted.
- Required: At least 5 years of experience in a bioanalytical laboratory, clinical laboratory, research laboratory, or biotechnology company.
- Required: Excellent writing and verbal communications skills and experience with GLP or GMP documentation and testing.
- Preferred: Skills with immunoassays and other bioanalytical methods in a GLP-compliant environment, or equivalent analytical experience in a regulated lab environment.
- Experience with Watson LIMS, statistical analysis and JMP software.
Preferred: Bachelor’s or equivalent experience with immunoassays or other quantitative bioanalytical methods in a biological or biochemical field.
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.