Manager, 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.ResponsibilitiesThe Manager role is responsible for an assigned area within the Gene Therapy Pilot plant. Collaborates with support groups to ensure accurate and smooth process transfer and production. Oversees the planning, implementation and execution of operations for new products and technologies in a cGMP environment. 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. Ensure the efficiency of materials, processing requirements, equipment function and personnel performance for the day to day operations. Provide technical expertise to resolve manufacturing issues. Interact with support groups to ensure targets are met and product and process comply with cGMP guidelines. Lead operational staff, developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable. Issue deviations and change requests and work with department manager and/or QA professionals to evaluate, process and close records. Set project timeframes and priorities based on objectives with effective tracking and management of progressEXPERIENCERequired Skills: 8 years of directly related industry experience, including at least 2 years with proven leadership role and 4 years of cGMP manufacturing experience. Experience with process development, process transfer, validation or gene therapy manufacturing operation is a plus. Strong organizational, collaborating and communication skillsEDUCATIONB.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience. M.S. degree is a plus.WORK ENVIRONMENT/PHYSICAL DEMANDSThe employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.The position may require off hours support as required. The position will require shift work and potentially including weekends, off hours and holidays. 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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