Supervisor, Manufacturing (Downstream Operations)Location 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 shift work; 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 Mfg 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 all operations are in full compliance with regulatory and safety guidelines
Demonstrate a high level of understanding and experience with cell culture technologies, automation controls, and compliance
Demonstrate technical proficiency in area of responsibility and ability to provide technical instruction and training processes to staff and team
Troubleshoot and identify issues while supporting resolution with outside 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 department Manager and/or QA professionals to evaluate corrective actions (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
Ensure production and processes comply with cGMPs
Perform 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.
Recommend actions and exercise discretion in regard to processes within work area
Uses data analysis tools and methodologies and apply sound 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 1+ 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.