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Analyst, QC I (TEMPORARY)

Location Novato, California
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. 

Duties


The QC In-Process (QCIP) Analyst is responsible for performing microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, and Total Organic Carbon.



Functional activities may include: performing a wide variety of microbiological and/or analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorm further development or improvement ideasfor procedures.



Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively.

Skills


Timely facilitationof incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.



Execute microbiological and/or analyticalmethodsto facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the promptreporting of results to meet the required timetables of internal customers.



Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges.



Perform and collaborate with co-workers to ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.



Assist with monitoring and the control of laboratory supply and critical reagent inventories.


Education


Bachelor of Science degree.

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


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.

About our location

Novato

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