Supervisor, Manufacturing (Grave Shift)
Hiring Manager: Brian Szeto ([email protected])
Description
Who We Are
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.
Manufacturing Supervisor - Overnight Shift (18:00 - 07:00) Thursday - Saturday and every other Wednesday
KEY RESPONSIBILITIES
· Leadership
- Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
- Accomplishes tasks through direct and effective coordination
- Provides direction and hands-on training for staff
- Supports the management of staff with supervisor
- Lives department values and sets the standards for others to operate
- Fosters an environment of compliance, strong work ethic and ongoing learning
· Contribution
- Ability to take responsibility for moderate level projects
- Effective interaction with peer Leads across manufacturing to create alignment and improvement
- Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities
· Process Knowledge
- Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
- Ability to troubleshoot, identify issues and support resolutions with technical groups
- Required to perform ongoing operational tasks in respective work area
- Uses scientific thinking and decision making in daily work
· Technical Competency
- Proven experience with relevant process, theory and equipment
- Experience with process automation and functionality
- Assist with review and approval of documentation including Batch Records and logbooks
- Support the closure of Manufacturing owned Quality Records (deviations, change requests)
· Quality and Compliance
- Complete understanding and adherence to cGMP’s as related to commercial operations
- Initiate and own required Corrective and Preventative actions and lead change control actions
- Support the closure of manufacturing discrepancies and change requests
- Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products
· Business
- Experience business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)
- Support trending and communication of defined department metrics
- Identify and drive opportunities for process & business optimization
- Translates company and department goals into actionable objectives for self and staff
· Other duties as assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.