Job Description
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin\u2019s 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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients\u2019 lives. SUMMARY:The Bioanalysis group characterizes, validates, and performs novel assays to measure pharmacokinetics, immunogenicity, and biomarkers for BioMarin\u2019s pipeline of drug candidates. We are searching for a highly motivated bench Research Associate with 6 years of experience 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. This position will interact with other scientists in BioAnalytical Sciences as well as key collaborator and stakeholder groups across Translational Sciences 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.RESPONSIBILITIES:Subject matter expertise in analytical methods to detect biomarkers, drug, and antibodies to therapeutics in biological matrices. Methods include molecular biology assays such as polymerase chain reaction (PCR, ddPCR), ligand binding assays such as enzyme-linked immunosorbent assays (ELISA), and cell-based assays. An in-depth understanding of PCR assays is required. Independently perform qualification/validation and testing for assays that support research and GxP regulated studies. Ensure GxP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices when applicable. Independently design, execute, interpret complex experiments, and summarize results; then, propose interpretations and next steps to manager, Bioanalytical Sciences, or key stake holders. Prepare SOPs, reports, and documents to support nonclinical and clinical programs and associated regulatory submissions. This includes validation protocols, validation reports, memoranda, and Bioanalytical reports for testing results. Lead assay outsourcing as a Bioanalytical Monitor from assay transfer through validation and sample testing.\u00A0 A key component of monitoring includes ensuring that assays are fit for their intended purpose and that they meet scientific and regulatory expectations throughout their lifecycle.\u00A0 Mentor more junior analysts.\u00A0EDUCATION & EXPERIENCE:\u00A08 years of experience in biomedical sciences, with demonstrated experience in a bioanalytical, clinical or nonclinical laboratory with a Bachelor's degree - OR -\u00A0 6 years of experience with a Master\u2019s degree. Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidance. Familiarity with laboratory electronic systems and applications (such as Watson LIMS and ELN) is a plus 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.\u00A0We 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.PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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