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Sr. Associate, Manufacturing

Company: BioMarin Pharmaceutical Inc.
Location: Novato
Posted on: January 12, 2022

Job Description:

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. KEY RESPONSIBILITIES:The Fill Finish-- -Sr. Associate-- -is responsible for ensuring safety and compliance with cGMP's maintained at all times. Ensures the efficiency of-- -materials, processing requirements, and equipment function for day to day operations.-- -For a-- -Sr. Associate-- -dayshift-- -shift M-F 7am-4pm responsibilities include-- -ensuring mission, vision, and department objectives are met.PROCCESS KNOWLEDGEUnderstanding of process theory and equipment operationAbility to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance and/or fill finish procedures; and perform all aspects with a broad understanding of scientific , compliance, and technical components-- -Support initiatives for process optimizationIdentify and elevate processing issues and support solutionsDemonstrated experience with automation systems (LIMS, MES, PI, etc.)TECHNICAL DOCUMENTATIONProvide feedback and/or suggested changes to operational proceduresAssist in the incorporation of new technologies, practices and standards into proceduresCapable of writing and reviewing process documentsQUALITY AND COMPLIANCEUnderstanding of cGMPs as related to Clinical and/or Commercial OperationsAbility to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)BUSINESSAbility to participate on projects and contribute to outcomesCapability to learn and support new business systems (Track wise, ERP, etc.)Support trending of defined department metricsOther duties as assigned. EDUCATIONBachelor's degree in science related area or engineering or Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry-- -EXPERIENCEBroad-- - knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, centrifugation and formulationAbility to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the positionProficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and-- -data capture-- -WORK ENVIRONMENT/PHYSICAL DEMANDSConsists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.May require work around loud equipment.The use of personal protective equipment will be required.Requires various shift based work and off hoursSpecific vision abilities by this job include close vision, depth perception and ability to adjust focus. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: BioMarin Pharmaceutical Inc., Novato , Sr. Associate, Manufacturing, Other , Novato, California

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