Associate, Manufacturing (Day shift)Location Novato, California Apply
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.
Understanding of process theory and equipment operation
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, buffer solution preparation, protein purification and formulation of bulk drug substance
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)
Provide feedback and/or suggested changes to operational procedures Assist in the incorporation of new technologies, practices and standards into procedures
Capable of writing and reviewing process documents
QUALITY AND COMPLIANCE:
Understanding of cGMPs as related to Commercial Operations Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
BUSINESS: Ability to participate on projects and contribute to outcomes Capability to learn and support new business systems (Track wise, ERP, etc.)
Support trending of defined department metrics
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.