Supervisor, Downstream OperationsLocation Novato, California Apply
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.
The Supervisor of Manufacturing is responsible for leading a department of supervisors and operations 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 current Good Manufacturing Practice 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 (Swing shift) and potentially including weekends, off hours and holidays.
The Manufacturing Supervisor is responsible for a discrete shift within department floor operations; ensuring safety and compliance with cGMPs are maintained at all times. Ensures the efficiency of material, processing requirements, equipment function and personnel performance for day to day operations. As a leader of a shift, provides tactical and supervisory leadership so that mission, vision and department objectives are met.
· Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance and safety guidelines.
· High level of understanding and experience with cell culture and purification technologies, automation controls, compliance and theory.
· Technical proficiency in area of responsibility and ability to provide technical instruction and training processes to staff and team
· Troubleshoot, identify issues and support resolution with support groups
· Ability to perform operational tasks in respective work area
· Responsible for interviewing, selecting and training staff to maintain workforce
· Provides effective leadership through:
· Assessing and managing performance of direct reports, team and self
· Individual goal setting and performance reviews
· Manage performance issues, development and enforcing policies
· Ensure the use of safe and compliant work practices and behaviors
· Issue deviations and change requests and work with depart manager and/or QA professional to evaluate CAPA, assist with closure and implement actions
· Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs
· Core quality commitments (logbook and BR review, maintain training compliance, assist with revision of procedures and batch records)
· Ensure staffing levels and skill sets are maintained and training is in compliance
· Oversee floor staff and process operations, identify and coordinate repairs, identify and assist with deviations, review batch records, author change requests for improvements.
· Recommends actions and regularly exercises discretion in regard to processes within work area
· Uses data analysis tools and methodologies and applies judgment to solve systematic problems
· Accountable for operations and results on an assigned shift
· Applies broad processing knowledge and experience to complete work and develop team
· Executes on objectives and goals to support a positive, efficient and motivated team
· Plans and oversees the daily activities of a work team
· Assigns tasks appropriately to ensure accurate completion is achieved
· Provides training, guidance and development to others
· Spends a portion of time performing the work with the team
· Manages a team of processing associates
· B.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 at least 2+ years with proven leadership role
· Ability to independently manage work, actions and expectations is essential
· Demonstrated technical expertise in large scale processing with various complex cell culture platforms
· Experience with process development, process transfer, validation and multi-product operations
· Strong organizational, collaborating and communication skills
· May have in excess of 5 direct reports to supervise
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.