Supervisor, Manufacturing

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 83,900 - 115,390; Full time

Benefits offered by this job

Health insurance

Paid time off

Discretionary annual bonus

Job summary

BioMarin Pharmaceutical Inc. in Novato, CA, is seeking a leader in Technical Operations to oversee daily manufacturing operations. The ideal candidate will have a B.S. in Life Sciences or related field, with at least 4 years of industry experience and 2+ years in a leadership role. Responsibilities include managing complex projects, training staff, and ensuring compliance with FDA regulatory standards. The role requires strong problem-solving skills and effective communication abilities. A competitive salary and benefits package are offered.

Qualifications

• 4+ years industry experience, including 2+ years in a leadership role.
• Ability to manage work independently is essential.
• Strong knowledge of FDA and EMEA guidelines.

Responsibilities

• Manage daily operations in the manufacturing area.
• Coordinate complex projects and provide hands-on training for staff.
• Ensure compliance with quality standards and regulatory requirements.

Skills

Project management

Process optimization

Effective communication

Technical understanding of cGMP

Leadership

Troubleshooting

Education

B.S. degree in Life Sciences, Engineering, or Applied Physics

Tools

Process historian

LIMS

Trackwise

ERP

MES

Job description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients' lives.

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
• Management of staff
• 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 complex projects
• Effective interaction with peers 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
• Technical Documentation:
• Provide feedback and/or suggested changes to operational procedures
• Assist in the incorporation of new technologies, practices and standards into procedures
• Capable of writing and reviewing process documents

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 with business systems (Process historian, LIMS, Trackwise, ERP, MES)
• 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.

SHIFT DETAILS

• Shift: Sunday - Tuesday + E/O Wednesday, 6am to 7pm
• MFG area is specific to Drug Substance Cell Culture
• 100% time on site
• 50% time on plant floor

EDUCATION

• B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.

EXPERIENCE

• 4+ years of directly related industry experience, including at least 2+ years with proven leadership role
• Ability to independently manage work, actions and expectations is essential

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

The salary range for this position is: $83,900 to $115,390. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.