Supervisor, QC Microbiology

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.

OVERVIEWThe 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.

CHARACTERISTICSThis 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.
RESPONSIBILITIESMajor responsibilities may include but are not limited to: 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 Training/Compliance · 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

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