Description

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.

Role Summary

The Associate Director, QC Microbiology (QC Micro) Laboratory is responsible for leading a team of analysts, associates, leads, supervisors, and managers to meet the deliverables of the QC Micro organization within the Microbiology in-process and FBDS routine testing and environmental monitoring laboratories. The Associate Director is responsible for overseeing the EM program and maintaining the cleanrooms for GMP commercial and clinical manufacturing facilities.

The main areas of QC Microbiology activity are:

• Oversight of day-to-day laboratory operations
• Ensuring GXP compliance within the laboratory and maintaining an investigation-ready state
• Manages and tracks QC Microbiology deviations, CRs, CAPAs, and laboratory investigations and ensures that records are closed within expected timeframes
• Coach and develop individuals within the group
• Author, review and approve documents such as standard operating procedures and QMS records

Key Responsibilities

• Lead a group of 4 – 10 direct reports focused on routine testing within the laboratory
• Provides operational and technical leadership to the Microbiology Department through management, planning and allocation of resources
• Develop, measure, and maintain processes to increase accuracy of testing and turnaround time
• Provide cGMP expertise for all aspects of testing and investigations
• Coach and develop individuals within the group
• Responsible for leading development discussions with direct reports in areas of professionalism and personnel development
• Responsible for overall performance of the team in areas of routine testing to ensure samples are tested and results reported within expected timelines
• Contributes to the hiring and the performance management of the team
• Collaboration with Manufacturing, other areas of Novato QC, Supply Chain, Facilities, and Quality Assurance to ensure successful QC Laboratory operations
• Develop and maintain both internal and external relationships
• Author, review and approve documents such as standard operating procedures and QMS records
• Manages and tracks deviations all QMS records and ensures that records are closed within expected timeframes
• Ensure the team is compliant to GXP and safety and environmental standards
• Oversee, document, and manage alert / action limit investigations
• Identify opportunities for and implement continuous improvement initiatives within the team
• Participate in and ensure support for cross-functional teams
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Develop, measure, and maintain processes to increase accuracy of testing and turnaround time
• Lead and implement initiatives that add value to the QC and site operations
• Prepare for and respond to internal and external audit findings
• Provides operational and technical leadership to the Microbiology Department through management, planning and allocation of resources
• Other job responsibilities as assigned

 

Qualifications

• BS degree in Microbiology or related field with 7-10 years of technical lab experience and at least 5 years of managerial experience. MS in Microbiology or related field with 5+ years of technical lab experience and at least 5 years of managerial experience
• Experience in a GMP Quality Control environment is required
• Experience with Environmental Monitoring and testing (BioBurden, LAL, TOC, Conductivity, etc.) is required
• Demonstrates tactical and analytical thinking and planning skills, and to develop plan to accomplish objectives, identify obstacles and resolve operational issues

This is a hybrid role based in Novato, CA. BioMarin defines hybrid as 2-4 days onsite per week.  

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.