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 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.
- Subject matter expert in a variety of analytical methods to detect biomarkers, drug, and antibodies to protein therapeutics in biological matrices. Techniques include (but are not limited to) nucleic acid extraction, reverse transcription (RT), and polymerase chain reaction (PCR) as well asenzyme-linked immunosorbent assays (ELISA), electrochemiluminescence assays (ECLA), and cell-based assays. Experience with molecular biology techniques and PCR based assays is required. Independently perform in-house testing for assays that support GxP regulated and research studies.
- Bioanalytical Monitoring of outsourced assays for assay validation, sample testing, and assay performance metrics; experience with managing vendors preferred.
- Independently design, execute, troubleshoot, and interpret complex sets of experiments or procedures, and summarize results; then, propose interpretations and next steps to manager or key stake holders.
- Present results, conclusions, and implications to BioAnalytical Sciences groups.
- Lead assay transfers from Assay Strategy and Development to Bioanalysis and from Bioanalysis to contract vendor labs.
- Mentor more junior analysts.
- Experience with laboratory electronic systems and applications (such as ELN and LIMS) and functional subject matter expertise with assay-associated laboratory instrumentation and analysis software (Bio-Rad QX One or Bio-Rad QX200 experience a plus)
- Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Ability to interact with BioMarin GxP Compliance regarding data auditing and participate in internal and external inspections and audits.
- 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.
- 6+ years of experience
- in biomedical sciences, with demonstrated experience in a bioanalytical, clinical or nonclinical laboratory, 4+ years of experience with a Master’s degree.
- Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidances.
- 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 6+ years of experience, Masters (MS) degree in a biological or biochemical field, with 4+ years of work experience within 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.