Lead, Manufacturing (Day Shift)

Biomarin Pharmaceutical • Novato, CA

5d • Onsite

About The Position

WHO WE ARE BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. ABOUT TECHNICAL OPERATIONS 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. Role GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin's innovative manufacturing processes and facilities, 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.

Requirements

• 2-4+ years Manufacturing experience
• Familiarity with manufacturing softwares, Bioreactors, CIP skids
• Communication with other groups

Nice To Haves

• Delegating work
• 0-2 years experience leading a team
• Following production schedule
• Experience with Oracle EBS, MES, Microsoft Teams
• BA/BS desired, not required

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://careers.biomarin.com/benefits .
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees