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Form of workBioMarin’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: Shift Details: Swing shift, 4 10hr shifts (Wednesday-Saturday) 11am-10pm onsite in Novato, CA The Quality Control Microbiology (QCM) Supervisor is responsible for supervising a GMP laboratories supporting microbial test and release of drug substance intermediates from biopharmaceutical manufacturing from cell culture up through final formulation and the environmental monitoring and utilities monitoring of GMP facilities. Additional responsibilities include investigative testing, sterility testing, microbial identification, aseptic processing, and contamination control. This position is responsible for supervising the work of several analysts, performing and reviewing a wide variety of tests/results for biological, biochemical and chemical test reactions, environmental monitoring sampling, microbial identifications, and reagent preparation. All responsibilities must involve a working knowledge that includes but is not limited to the following concepts: facility and utility EM sampling, water testing, Endotoxin detection, Bioburden quantification, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation. In addition to technical expertise, this role is intended to offer guidance for group and individual trajectories, and actively set a standard for teamwork. CHARACTERISTICS This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QCM labs while maintaining open communication channels with multiple departments to meet the needs of the organization. The incumbent will provide day to day direction to staff and support laboratory activities. RESPONSIBILITIES Personnel Management:
- Supervise the QCM team while embodying the principles of the BIOMARIN Leadership model.
- Interview and hire potential candidates to fulfill business needs.
- Motivate and retain talented individuals within the QCM Department
- Manage and develop the performance of direct reports by setting clear performance goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance.
- Timely address discipline and performance issues
- Ensure execution of QCM laboratory activities in strict accordance with Standard Operation Procedures, GMP and Regulatory requirements
- Schedule and/or deliver training to QCM personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely and compliantly.
- Production and Routine Support
- Assign tasks, create and update laboratory schedule.
- Supervise operations in the QCM Lab during the applicable shift.
- Represent the functional area in meetings and compliance activities.
- Analyze environmental and utilities monitoring sample collection and testing of facilities, equipment, and utilities.
- Analyze In-Process data and generate trending/product review reports
- Review and audit documentation to ensure accuracy, specifications and GMP compliance
- Coordinate and oversees laboratory testing execution to produce results in timely manner without compromising quality.
- Review SOPs, coordinate method development and ensures concurrency with cGMP regulations and requirements.
- Maintain and control laboratory inventories.
- Maintain positive relationship and network effectively across sites and organizations.
- Validate methods and laboratory equipment and write procedures.
- Provide laboratory support for inspection readiness.
- Work with Project Teams to drive timelines and efforts to the common goal.
- Ensures compliance with 21CFR, USP, EP, and ICH regulatory guidelines.
- Utilize process, technical knowledge and investigation skill to identify and rectify departmental issues.
- Contribute to the improvement of all QCM systems.
- Assist in the development of procedures and troubleshoot assays.
- Ensure Personnel Protective Equipment is used in the laboratory area
- Ensure proper handling and disposal of chemical and reagents
- Encourage safety behavior within the laboratory area
- Timely address safety incidents
- Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results
- Participate in the investigation of Alert/Action, excursions and atypical results
- Exceptional People Leadership including motivates, inspires, builds, and retains highly effective laboratory teams while managing for high performance and developing others.
- Versatile learner and courageous decision maker.
- Effectively operate in an evolving complex and dynamic environment.
- Provides clear direction and instruction to direct reports.
- Continuously looking internally and externally for best practices and areas for improvement.
- Understands patient and customer needs and builds relationships as required to meet departmental goals.
- Continuously improves operations by setting high standards for the team so they may perform to a level of excellence.
- Detailed knowledge of quality management systems, current Good Manufacturing Practices,
- Expertise with QC principles and compliance requirements is required.
- Excellent documentation, written and verbal communication skills are essential
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
