Supervisor, Gene Therapy Manufacturing (Night Shift)
Novato, CA
Who We Are 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. Supervisor of Manufacturing is responsible for leading operational staff, developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable. The Supervisor is accountable for plant activities, monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing complete documentation of all required production activities and ensuring compliance with the Good Manufacturing Practices regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position may require off hours support as required. The position will require shift work and potentially including weekends, off hours and holidays.The supervisor is responsible for a discrete shift\u00A0within department floor operations; ensuring safety and compliance with cGMPs are maintained as all times. Ensures the efficiency of materials, processing requirements, equipment function and personnel performance for the day to day operations. As a leader of a shift, provides tactical and supervisory leadership so that the mission, vision and department objectives are met.Processing: large scale purification processing chromatography columns, filtration skids, titration, automations and cell culture bioreactor processing. Technical proficiency in areas of responsibility and the ability to provide technical instruction and training process to staff and the teams.Development skills: provide leadership through assessing and managing performance of direct reports, team and self.Quality: issue deviations and change requests and work with department manager and or QA professional to evaluate, process and close records.Education: B.S. degree in life sciences, engineering, applied physics, etc., or acceptable equivalent combination of education and experience.Experience: 6 years of directly related industry experience, including 2 years with proven leadership role. Ability to independently manage work, actions and expectations is essential. Demonstrated expertise in large scale processing. Strong organizational and communication skills 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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