QC Analyst/Sr AnalystLocation 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.
The Quality Control Analyst/ Sr Analyst, under direct supervision, is responsible for performing biochemical, physical, and chemical evaluations of raw material, environmental monitoring, in-process, release, and stability samples.
This position requires willingness to undergo training on applicable analytical methods and safety policies. Work assignments will encompass performing and documenting activities from routine to non-routine in nature, and require the ability to recognize deviations from the accepted practice. Good record keeping, organizational, written and verbal communication skills are essential. The incumbent must be willing to work overtime and weekends as required.
Perform, under direct supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
Evaluate data against defined criteria/specifications.
Maintain laboratory supply inventories.
Maintain the laboratory in an inspection-ready state.
Develop proficiency in a limited number of tests.
Timely complete of assignments
- Execute routine testing, method optimziation, validation experiments
At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
Sr Analyst- At least 4 years’ experience, quality control preferred.
Ability to follow written instructions and to perform tasks with direct supervision.
Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel,Typing).
Good written and verbal skills.
Strong record keeping skills
- Sr Analyst- expertise in several of the following method types: HPLC (RP, SEC, SCX, etc), ELISA, cellular uptake, enzymatic activity,
- Analyst: B.S./B.A. in a scientific discipline with 0 - 2 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.
- Sr Analyst: B.S./B.A. in a scientific discipline with at least 4 years of relevant laboratory experience or A.S. with at least 6 years of relevant laboratory experience.
Analyst must develop skills in the operation and routine maintenance of various analytical instruments. Sr Analyst must have previous experience with some of the following equipment: HPLC (Waters preferred), Spectrophotometer,
Reports to Quality Control Scientist 2. Interacts with several departments, including but not limited to Regulatory, Manufacturing, Quality Assurance, Maintenance, Engineering, and Process Development.
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.