Lead, Manufacturing (Day Shift)

Role Summary

Lead, Manufacturing (Day Shift) responsible for daily operations in the area, establishing and maintaining BioMarin’s manufacturing processes, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.

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)
• Other duties
  • Other duties as assigned.

Qualifications

• Required: 2-4+ years Manufacturing experience
• Required: Familiarity with manufacturing softwares, Bioreactors, CIP skids
• Required: Communication with other groups
• Preferred: Delegating work
• Preferred: 0-2 years experience leading a team
• Preferred: Following production schedule
• Preferred: Experience with Oracle EBS, MES, Microsoft Teams

Education

• BA/BS desired, not required

Additional Requirements

• SHIFT DETAILS: This position is for the Thursday-Saturday (plus alternating Wed) 6am-7pm shift
• ONSITE: Onsite only
• Travel Required: None