Scientist 1/2 Translational Sciences, Bioanalytical ResearchLocation 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 BioAnalytical Sciences group within Translational Sciences generates data to answer key questions during the non-clinical and clinical development of new therapeutics. We are searching for a talented and highly motivated Scientist to join our team.
The successful candidate will participate in programs that range from exploratory in vitro and animal studies, non-clinical efficacy and safety studies, and clinical trials. You will be responsible for developing new methods, evaluating novel technologies, and conducting translational research internally at the BioMarin Research Center and externally in partnership with contract research organizations. This position offers a unique opportunity to interact with scientific and business colleagues across many functional areas, including Research, Translational Sciences, Regulatory Affairs, and Clinical Sciences.This Scientist position will report to a Principal Scientist in Assay Strategy and Development and will have the opportunity to advance our most promising pipeline candidates to treat rare genetic diseases.
- Independently develops, performs and oversees a variety of analytical methods to support drug development and address translational research questions. Techniques may include ELISA/ECL, cell-based assays, enzyme activity assays, PCR, qPCR, ddPCR, surface plasmon resonance, and flow cytometry.
- Oversees internal and external development and validation of a variety of bioanalytical methods to detect drugs, antibodies to drugs, and biomarkers in biological matrices.
- Plans and executes biomarker strategy for non-clinical and clinical studies.
- Presents results, conclusions, and implications to project teams and senior management.
- Demonstrates sustained leadership and influence on department policies
- Maintain a detailed awareness of industry guidances and standards for assay validation and performance.
- May serve as Principle Investigator for GLP assays, participate in audits and inspections, and adhere to regulatory compliance standards.
- Manages technology and process transfers between groups and vendors.
- Contributes to non-clinical and clinical study protocols, and regulatory reports.
- Reviews and approves reports and documents such as validation protocols, validation reports, and sample analysis reports.
- Manages and mentors research associates
- Participates in scientific meetings and produces original peer-reviewed publications
- Serves as an expert liaison to other departments
- Other duties as assigned
The Scientist has a significant impact on the company’s ability to reach its goals in a timely manner, with respect to addressing key scientific and translational research questions and delivery of developed and validated methods to support preclinical and clinical studies.
Doctorate (Ph.D.) degree in immunology, neuroscience, biochemistry, molecular or cellular biology with > 2 years of experience in an academic lab or biotechnology company.
- PhD or equivalent relevant experience, plus 0-2+ years industry experience
Scientist 2 :
- PhD or equivalent relevant experience plus 2-5+ years industry experience
- Doctorate (Ph.D.) degree in immunology, neuroscience, biochemistry, molecular or cellular biology
- Strong written and verbal communications skills.
- Experience with GLP documentation preferred.
- Experience with laboratory equipment and software required for translational research, may include immunoassays, cell culture, mass spectrometry, and/or chromatography.
- Windows network or Mac environment, MS Office, etc.
WORK ENVIRONMENT / PHYSICAL DEMANDS
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
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