Supervisor, ManufacturingLocation Novato, California
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 team of operations staff; developing staff capabilities, maintaining training objectives, maintaining compliance, building collaboration, and creating a culture of safety, while implementing process improvements where applicable. The Supervisor is accountable for plant activities within the confines of a shift schedule and the performance of direct reports. This accountability extends to monitoring process operations, 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 a Manufacturing Department’s floor operations; ensuring safety and compliance with cGMPs are maintained at all times. Ensures the efficiency of material and process operations, and personnel performance for day to day operations. As a leader of a Manufacturing shift, provides tactical and supervisory leadership so that mission, vision and departmental objectives are met. The Manufacturing Supervisor may have in excess of 5 direct reports to supervise.
- 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 their respective work area
- Responsible for interviewing, selecting, and training staff to maintain a shift workforce within a Manufacturing organization
- Provide effective leadership through:
- Assessing and managing performance of direct reports, team, and self
- Individual goal setting and performance reviews
- Management of performance issues, development, and company policy enforcement
- Ensuring the use of safe and compliant work practices and behaviors
- Issue deviations and change requests as needed and work with department Manager and/or QA professionals to evaluate corrective actions
- Assist with the implementation of deviation and corrective 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 as needed
- 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 a 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
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.