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.
PURPOSEThe Quality Control Analytical Supervisor is responsible for supervising the biological, biochemical and chemical evaluation of in-process, drug substance, studies and investigational samples in support of the manufacturing process of commercial and clinical drug products. The incumbent will be responsible for reviewing, analyzing and reporting biological, biochemical and chemical testing results. 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, and reagent preparation. The incumbent will be responsible for completing assignments timely, for troubleshooting, and for follow-up on any testing issues. All responsibilities must involve a working knowledge that includes but is not limited to the following concepts: Water testing, Protein determination by Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, Total Organic Carbon, 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.** This role will support Swing Shift, Wednesday to Saturday, 1:00pm-12:00am ** CHARACTERISTICSThis motivated and organized individual with strong people skills will provide supervision and technical expertise to the QCA lab while maintaining open communication channels with multiple departments to meet the needs of the organization. They will provide day to day direction to staff and support laboratory activities. RESPONSIBILITIES*Major responsibilities may include but are not limited to:Personnel Management• Supervise the QCA 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 QCA 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 issuesTraining/Compliance• Ensure execution of QCA laboratory activities in strict accordance with Standard Operation Procedures, GMP and Regulatory requirements• Schedule and/or delivers training to QCA personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely and compliantlyProduction and Routine Support• Assign tasks, create and update laboratory schedule• Supervise operations in the QCA Lab during the applicable shift• Represent the functional area in meetings and compliance activities• 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 21 CFR, USP, EP, and ICH regulatory guidelinesContinuous improvement• Utilize process, technical knowledge and investigation skill to identify and rectify departmental issues• Contribute to the improvement of all QCA systems• Assist in the development of procedures and troubleshoot assaysSafety• 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 *Perform other responsibilities as deemed necessary. BASIC QUALIFICATIONSB.S. degree in a biological or biochemical science and at least 4 years of experience in a pharmaceutical laboratory (at least 2 years in QC) that includes some supervisory experience. M.S. degree with at least 2 years of GMP laboratory experience.LEADERSHIP QUALIFICATIONS• 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. PREFERRED QUALIFICATIONSCandidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results. Experienced managing direct reports and processes. Strong time management and organizational skills. Strong people skills. Training experience. Experienced in facilitating meetings. Ability to effectively maintain a team-work environment. Experience authoring and reviewing SOPs, OJTs, test records and other controlled documents. EXPERIENCE1. Detailed knowledge of quality management systems, current Good Manufacturing Practices,2. Expertise with QC principles and compliance requirements is required.3. Excellent documentation, written and verbal communication skills are essential.4. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.5. Working knowledge of statistics along with advanced software expertise, such as within JMP or LIMS, is optimal.6. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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.
