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.
- Optimize, validate, and troubleshoot assays.
- Perform biochemical/chemical analyses of samples to support process development, manufacturing investigations, and assay validation samples under cGMP to meet specified timelines.
- Maintain lab in inspection ready state
- Support lab equipment management
- Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations.
- Draft written QC test method SOPs for new assay methods.
- Interface with contract facilities and other BioMarin departments as necessary.
- Well-developed laboratory skills for analysis of small molecule and biopharmaceuticals.
- Comfort with coordinating the activities of other staff members and other groups.
- At least two years in a cGMP laboratory; quality control experience preferred.
- Experience in method development, optimization, qualification, validation, transfer.
Experienced with molecular biological and analytical methodologies such as ELISA, Capillary Electrophoresis, HPLC, Activity, Enzyme Kinetics, and Cellular Uptake.
Preferred experience with many of the following: HPLC, UPLC, Spectrophotometers, Plate readers, LIMS, Softmax Pro, Empower..
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
B.S./B.A. in science (majors: biology, biochemistry, chemistry or similar) with at least 5 years experience in a relevant functional area, documentation of specialized training relevant to the position, and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. M.S. with at least 3 years of experience in a relevant functional area and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies..
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.