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.
Critical to the success of each new therapeutic, the Bioanalysis group characterizes, validates, and performs novel assays to measure pharmacokinetics, immunogenicity, and biomarkers. We are searching for a highly motivated bench Research Associate to validate, implement, perform, and maintain assays that will impact non-clinical and clinical studies. This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early non-clinical programs through all stages of clinical development. The successful candidate will interact with other members of BioAnalytical Sciences as well as key collaborator and stakeholder groups such as Translational Sciences, Clinical Operations, and GLP-Compliance to advance our most promising pipeline candidates. You will be able to learn and apply new platforms that further accelerate drug development, while maintaining a critical eye on assay quality and maintaining regulatory standards
- Perform 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), and polymerase chain reaction (PCR) as well as enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence assays (ECLA), and cell-based assays. Experience with molecular biology techniques and PCR based assays preferred.
- Bioanalytical Monitoring of outsourced assays for assay validation, sample testing, and assay performance metrics.
- Independently perform quantitative analysis within and across multiple experiments, including basic statistical and graphical analysis, and summarize results; then, propose interpretations and next steps with guidance from manager.
- Present results, conclusions, and implications to BioAnalytical Sciences group.
- Experience with laboratory electronic systems and applications (such as ELN and LIMS) and familiarity with assay-associated laboratory instrumentation and laboratory equipment.
- Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Prepare SOPs and other reports and documents to support nonclinical and clinical programs and associated regulatory submissions. This includes validation protocols, validation reports, memoranda, and data reports for testing results.
- Document all experimental procedures and data.
- Share responsibility for lab maintenance duties.
- Other duties as assigned.
- 4+ years of experience in biomedical sciences, with demonstrated experience in a bioanalytical, clinical or nonclinical laboratory.
- Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidance.
- Excellent verbal and written communication skills: ability to cogently prepare and present data in group settings, prepare formal reports, give and receive useful feedback.
- Ability to use computer effectively for data analysis and presentation.
- Bachelor (BS / BA) degree in a biological or biochemical field, with 4+ years of experience, Masters (MS) degree in a biological or biochemical field, with 2+ years of work experience with in a bioanalytical, clinical or nonclinical laboratory.
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.