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 Manufacturing Manager is responsible for an assigned area within a plant with oversight over either Upstream or Downstream operations. Through collaboration with support groups, the manager is responsible for ensuring accurate and well managed transfer of process changes/improvements to floor operations, integrates best practices, where appropriate, into manufacturing and oversees the planning, implementation and execution of manufacturing operations for new and/or existing products and technologies in a cGMP environment. The Manufacturing Manager is also responsible for leading a department of supervisors and operations staff, developing staff capabilities, creating a culture of safety, while maintaining training objectives.
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.
- Control and involvement of operations and activities that occur in an assigned area within manufacturing.
- Ensure consistent product quality through implementation of effective systems and collaboration with key support groups (QA, MSAT, ENG, FAC, etc.)
- Broad technical knowledge in area of responsibility and provides technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnel
- Involved in hiring and monitoring process to maintain staffing levels
• Provides effective leadership through:
- Managing performance and expectations of direct reports, team and self
- Manage performance issues, development and policies
- Ensure the use of safe and compliant work practices and behaviors
- Own and approve deviations and change requests within assigned work area.
- Manage required actions with department and collaboration with support groups to meet quality commitments and established timelines
- Provide technical expertise to resolve manufacturing issues. Interact with support groups to ensure targets are met and product and process comply with cGMPs
- Owner of Standard Operating Procedures and Batch Records
- Ensure staffing levels and skill sets are maintained and training is in compliance
General Look-Ahead: 1 year
- Monitor and manage all aspects of performance in an assigned manufacturing area
- Translates business plans and organizational goals into actionable objectives
- Influences approach for operations at campaign and daily execution
- Adheres to and executes policies and guidelines that directly affect work activities
- Champion self-initiated projects and drive area of control within context of defined priorities
- Accountable for operations and results of a assigned area in production plant
- Establishes and influences operations policies with focus on alignment across manufacturing plants when appropriate
- Communicate, interact and influence with peers and plant leadership
- Accomplishes results through professional staff and/or employees
- Sets project timeframes and priorities based on objectives with effective tracking and management of progress
- Provides guidance and technical advice and becomes actively involved as required
- Manages a team of supervisors and/or professionals
- Contributes to the standards around which others operate
- B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
- 8+ years of directly related industry experience, including at least 4+ years with proven leadership
- Ability to independently manage work, actions and expectations is essential