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Sr. Analyst, QC

Location Novato, California Workstyle Open to Hybrid
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.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

  • Proficient in the use of LIMS for data mining and running reports
  • Generation, maintenance and reporting of release and stability database for clinical and commercial products
  • Authoring and updating annual report sections with stability and summary of analytical method changes for Regulatory submissions
  • Supports updating/ review of Quarterly Stability Reports
  • Interfaces with other BioMarin departments (Regulatory Affairs, Quality Assurance, etc.) as necessary
  • Delivers continuous improvement by focusing on quality, efficiency, and compliance
  • Supports the transformation of the established process to an electronic solution for efficient, sustainable, planned & predictable performance
  • Supports CMC Module 3 authoring activities such as: Analytical Method Description, Method Validation, Batch Analysis and assembly of supporting documents
  • Five years experience in a cGMP environment or equivalent education in a scientific discipline

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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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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