Production Leadership Role

7 days ago


Novato, California, United States BioMarin Pharmaceutical Full time
About the Role

BioMarin Pharmaceutical is seeking a highly skilled Manufacturing Operations Supervisor to join our team. As a key member of our Technical Operations group, you will be responsible for overseeing the daily operations in our manufacturing area, ensuring effective communication, trouble shooting, and schedule adherence with minimal oversight.

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

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