Senior Research Associate I or II, BioAnalytical ScienceLocation 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.
Do you want to work as part of a team that executes the bioanalytical strategy to understand safety, efficacy, and mechanism of gene therapies and biotherapeutics that change patients’ lives? Do you want to develop and apply your knowledge of biology, molecular biology, immunology and biochemistry in delivering novel bioanalytical assays in support of non-clinical studies and clinical trials?
A Senior Research Associate I/II (SRA I/II) is an important member of a BioAnalytical team that provides key data to support regulatory submissions that lead to approval of drug candidates. The SRA I/II is a dynamic individual that is looking to advance their bioanalytical scientific expertise while maintaining a strong understanding of laboratory regulations and compliance, bioanalytical clinical and non-clinical study support, and contract vendor oversight. This role within the organization requires the ability to pivot between a diverse range of responsibilities, a willingness and desire to learn new methods, the ability to lead method validation per industry guidance, support regulatory filings, and to demonstrate leadership capabilities within the department. Bioanalytical support encompasses laboratory work ranging from routine to complex in nature including data analysis, technical reports, and presentations.
- A working knowledge of current techniques for bioanalytical methods such as ligand binding assays, cell-based assays, or PCR
- Ability to design and lead methodology and technology transfer within the department, as well as to external contract laboratories, ensuring GxP compliance
- Ability to lead assay validation and testing laboratory work, data collection, data review and analysis, and report generation compliant with FDA Guidance for Industry and EMA requirements
- Has the ability to recognize deviations from accepted practice and innovates to address new challenges
- Is adept at assay troubleshooting and maintenance execution and provides guidance for other research associates
- Works with other members of the BioAnalytical Team to meet program timelines and deliverables taking a leadership role when needed
- Will author department documentation such as SOPs, protocols, reports, deviations, and investigations
- Works independently with minimal supervision and able to manage concurrent projects
- Demonstrates strong scientific and critical thinking skills
- Experience with and understanding of bioanalytical methods such as: ELISAs, MSD bridging assays
- PCR validation experience a plus.
- Demonstrates good interpersonal skills showing initiative and resourcefulness
- Excellent organization, written, and verbal communication skills
- At least 4-6 years of bioanalytical experience
- Requires experience with GxP regulations, requirements, and testing; GLP experience preferred
- SRA I requires a Bachelor’s degree and at least 6 years of relevant experience in a bioanalytical laboratory, research laboratory, or biotechnology company; Master’s degree with at least 4 years of relevant experience
- SRA II requires a Bachelor’s degree and at least 8 years of relevant experience in a bioanalytical laboratory, research laboratory, or biotechnology company; Master’s degree with at least 6 years of relevant experience
- Bachelor’s or Master’s degree or equivalent experience with bioanalytical assays or other quantitative and semi-quantitative bioanalytical methods in a biological or biochemical field.
- Familiarity with various software programs including, but not limited to, Word, Excel, Access, Powerpoint, Watson LIMS, Electronic Laboratory Notebooks, and JMP statistical software or equivalent
- Experience with some of the following instrumentation would be valuable and willingness to learn is essential Molecular Devices Spectrophotometer, MesoScale Discovery Chemiluminescence Reader, Quanterix, Droplet Digital, Cantos Flow Cytometer, CTL Immunospot
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.