Manufacturing Operations Manager

5 days ago

Novato, California, United States BioMarin Pharmaceutical Full time
Job Summary

As a Manufacturing Supervisor at BioMarin Pharmaceutical, you will be responsible for leading the daily operations in the manufacturing area, ensuring effective communication, troubleshooting, and schedule adherence with minimal oversight. You will provide direction and hands-on training for staff, support the management of staff with supervisor, and live department values and set standards for others to operate.

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.
  • Contribution: Ability to take responsibility for moderate level projects, effective interaction with peer Leads across manufacturing to create alignment and improvement, and 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, and perform ongoing operational tasks in respective work area.
  • 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, and 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, and 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, and translates company and department goals into actionable objectives for self and staff.
About BioMarin Pharmaceutical

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.

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