Lead, Manufacturing (Grave Shift)

BioMarin Pharmaceutical Inc.Novato, CA
Onsite

About The Position

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 individuals 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.

Requirements

  • 2-4 years Manufacturing Experience
  • 0-2 years Leading a team
  • Familiarity with manufacturing softwares, Chrome skids, TFF skids
  • Delegating work, leading a team, following production schedule
  • Experience with Oracle, MES, Microsoft Teams, communication with groups
  • BA/BS desired not required
  • 1-2 years leading Manufacturing experience

Responsibilities

  • 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
  • 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
  • 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
  • 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)
  • Other duties as assigned
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