Supervisor, Manufacturing (Day Shift)

Who We Are

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.

KEY RESPONSIBILITIES

Leadership

• Lives department values and sets the standards for others to operate
• Appropriate decisions, trouble shooting, and schedule adherences with minimal
• Accomplishes tasks through direct and effective coordination
• Provides direction and hands-on training for staff
• Fosters an environment of compliance, strong work ethic and ongoing learning
• Accountable for the daily operations in area, requiring effective communication to make
• Oversight
• Management of staff

Contribution

• Effective interaction with peers across manufacturing to create alignment and improvement
• Ability to take responsibility for complex projects
• 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
• Uses scientific thinking and decision making in daily work
• Required to perform ongoing operational tasks in respective work area

Technical Competency

• Experience with process automation and functionality
• Assist with review and approval of documentation including Batch Records and logbooks
• Assist in the incorporation of new technologies, practices and standards into procedures
• Proven experience with relevant process, theory and equipment
• Provide feedback and/or suggested changes to operational procedures
• Capable of writing and reviewing process documents
• Technical Documentation:

Quality and Compliance

• Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products
• Complete understanding and adherence to cGMP’s as related to commercial operations
• Support the closure of manufacturing discrepancies and change requests
• Initiate and own required Corrective and Preventative actions and lead change control actions

Business

• Translates company and department goals into actionable objectives for self and staff
• Identify and drive opportunities for process & business optimization
• Support trending and communication of defined department metrics
• Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)

PREFERRED EXPERIENCE AND QUALIFICATIONS

• 6+ years of directly related industry experience, including at least 2+ years with proven leadership role
• Experience with cGMP's in a biologics manufacturing facility
• Technical expertise in large scale processing

Education
Bachelors degree with 1-3 years of leadership experience

Shift
Sun-Tues + every other Wed 0600-1900

Other duties as assigned.

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.

In the U.S., the salary range for this position is $ 88,000 to $ 132,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.