Technical Specialist 2, Business Operations
Novato, CA
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin\u2019s 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\u2019s 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\u2019 lives. KEY RESPONSIBILITIES\u00A0Interact with department leaders to ensure department and corporate objectives are met\u00A0Uphold safety standards\u00A0Displays department values and sets the standards for others to emulate\u00A0Ability to independently manage work and assigned projects\u00A0Responsible for projects that span multiple functional areas\u00A0Receive assignments in the form of objectives with defined goals\u00A0Perform regular Gemba Walks of the Novato manufacturing facilities\u00A0\u00A0Identify and drive opportunities for process optimization\u00A0Knowledge and experience in all aspects of GMP manufacturing\u00A0Complete understanding and adherence to cGMP\u2019s as related to commercial operations\u00A0Ability to troubleshoot, identify issues and support resolutions with technical groups\u00A0Effectively communicates with business partners\u00A0Experience with large scale automated process equipment and controls\u00A0Working knowledge with disposable systems, cell culture, purification, filtration, CIP & SIP operations\u00A0Support the closure of manufacturing discrepancies and change requests\u00A0Lead or participate on teams responsible for improving standard operating proceduresExperience with various business systems (PI, LIMS, QMS, ERP, MES, etc.)\u00A0Lead trending and communication of key department metricsSupport a culture or operational excellence and continuous improvementOther duties as assigned.\u00A0EDUCATION, EXPERIENCE AND EXPERTISE\u00A0B.S. degree in Life Sciences, Engineering, Applied Physics, etc.\u00A04 years of relevant industry experience\u00A0Acceptable equivalent combination of education and experience will be considered\u00A0Demonstrated technical expertise\u00A0Working knowledge of process automation, associated process equipment, and relevant technical documentationGreen Belt or Black Belt preferred\u00A0 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.
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