Supervisor, Gene Therapy Pilot Plant
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\u00A0 Plan and execute daily activities in the clinical MFG facility during production periods. Coordinate the support of internal and external resources to accomplish production goals with minimal oversight.\u00A0 Oversee a manufacturing shift including training, scheduling of vacation time, daily assignments and Perform document reviews and own some deviations and change controls. Provides direction and hands-on training for staff. Work with cross-functional partner groups to resolve technical and logistical challenges. Fosters an environment of safety, compliance, strong work ethic and ongoing learning Lead projects related to continuous improvement, operational readiness, and campaign startup/close out during non-production periods and support activities including non-clinical development runs, recipe programing and testing, and maintenance/calibration.Note: The position may require off hours support as needed. Shift work potentially includes weekends, off hours and holidays. Flexible scheduling including remote work is possible when pilot plant not in production.RequirementsLeadership Skills Ability to independently manage work, actions and expectations. Ability to manage and develop the staff by discussing individual development plans, providing feedback, and setting clear and attainable goals for staff. Strong organizational and communication skills. Understand the strategic decisions and be able to adapt changes as needed.Process Knowledge\u00A0 Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance Ability to troubleshoot, identify issues and support resolutions with technical groups Required to perform ongoing operational tasks in respective work area Uses scientific thinking and decision making in daily workTechnical Competency Able to handle large-scale bioprocessing including aseptic cell culture, single use bioreactor, or downstream chromatography operations. Have a strong foundation in GMP principles and be able to articulate and defend their decisions within a quality framework. Capable of drafting and reviewing standard operation procedures, batch records and other technical documents. Education/ExperiencesB.S. degree in life sciences, engineering, applied physics, etc., or acceptable equivalent combination of education and experience. 6 years of directly related industry experience, including 2 years with proven leadership role Candidates with M.S. or equivalent degree with less years of related industry experience may be considered. Previous experience with gene therapy manufacturing is a plus.Knowledge and experience with process development and technical transfer is a plus.About the Gene Therapy Pilot PlantThe gene therapy pilot plant is responsible for delivering BioMarin\u2019s extensive gene therapy pipeline to the clinic.\u00A0 We are part of the Process Science group within Technical Operations (TOPS) and work closely with the rest of the Process Science group to execute early phase manufacturing processes to support large scale development needs and/or provide GMP material for early phase clinical use.\u00A0 The team was founded in 2020 and expects to grow with the needs of BioMarin\u2019s clinical pipeline. 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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