QC Microbiology Analyst ILocation Novato, California Apply
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.
Description: The Quality Control Microbiology Analyst I, under direct supervision is responsible for performing microbiological, biochemical and chemical evaluations of the manufacturing facilities, utilities, equipment, raw materials and in-process samples. With experience, they would perform as a back-up for QC Microbial ID testing.
Under direct supervision, the incumbent will be responsible for performing environmental monitoring sampling and testing of the facilities, equipment and utilities under cGMP guidelines. In addition, they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines. Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices. The incumbent will be responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending and for follow-up on any testing issues or excursions. Good record keeping, organizational, written and verbal communication skills are essential. Functional activities could include: supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, raw materials and in-process microbiological and analytical testing, growth promotion of media and microbiological identification testing. The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method development, endotoxin, protein activity, TOC, and other similar analysis methods.
The shift for this position is from Tuesday-Saturday, Day shift (0800-1630) or Sunday-Thursday (1400-2030).
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.