Director, Quality Control Microbiology, Cell Therapy
Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. PURPOSE AND SCOPE OF POSITION: The principal functions of this position are: to provide senior leadership of the QC Microbiology department; overseeing cGMP testing including environmental monitoring in order to ensure product safety; lead cross-functional teams in support of product development, technology transfer, and raw materials planning. The Director/Sr. Director will be a key member of the team responsible for the design, implementation, and continuous improvement of all processes/systems in support of the Juno Manufacturing plant (Jump) contamination prevention program. In addition, the position will be responsible for developing and executing Junos corporate quality policies, practices, procedures, standards, and systems necessary to ensure adherence to aseptic production and product management in accordance to the cGXP compliance to US and EU regulations. REQUIRED COMPETENTIES: EDUCATION – BS/MS in Microbiology discipline – 10+ years of experience in management position including 2+ years as a Director. – Ph.D. in life sciences is desired. EXPERIENCE – Expertise in all areas of cGXP compliance and FDA/EMA regulations – Experience in hosting regulatory agency inspections is required – Commercial and clinical quality experience is required. – Background in Protein Biologics required. Background in Cell Therapy Manufacturing desired – Demonstrated experience building and leading exceptional teams – Experience with isolator technology is required DUTIES AND RESPONSIBILITIES: JOB RESPONSIBILITIES – Extensive management experience in a cGMP microbiology testing laboratory environment, with knowledge of regulatory, USP and Eur. Phr guidelines as related to Microbiology issues, aseptic processing, and biosafety of Junos cell therapy products in development. Proficiency with microbiological assay methodologies including sterility, container closure integrity testing, various microbial identification systems, and working knowledge of rapid microbiological techniques and technologies is required. Experience with isolator technology required. – The incumbent is responsible for collaborative cross-functional teamwork in organizing and developing the overall Quality Control Microbiology laboratory strategy and operation, with a concentrated focus on facility utilities, environmental classification and control design, program design for Microbiology laboratory equipment, facility qualification/control and the media fill program. Responsibilities include, establishing sound control systems to sustain the performance of the JuMP facility including the development of facility preventative maintenance measures. This position will be responsible for building and maintaining robust Environmental Monitoring programs that meet US/EU and other applicable regulatory requirements. – Organizes and directs cross functional relationships with manufacturing, engineering, quality control, development and regulatory. Responsible for the hiring of staff and management of contract vendors for major programs related to the microbiology laboratory. Directs the laboratory staff, sets goals for group leaders, establishes performance objectives for the department, and maintains efficient utilization of resources. Approves major documents required for regulatory submissions. Develops, implements and enforces Microbiology laboratory procedures and policies consistent with global systems, cGMP manuals, and other company policies. – Ensures continued professional development of staff through training and functional interactions with various operating groups throughout the supply chain. Additionally, this position will be responsible for determining laboratory best practices through collaboration across various company sites, Corporate Quality Operations, and the rest of the industry. Recruits staff with appropriate skills. Will make presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections. Position requires a degree in microbiological sciences with extensive industrial microbiology experience. – Coaches and develops team, by providing an environment that encourages ongoing personal and professional development. Manages and ensures the setting of goals, training and development opportunities, providing regularly scheduled feedback throughout the year. – Establishes, in collaboration with other Directors and Managers, overall policies and philosophies of the group. – Directs QC Microbiology operations to ensure that product testing is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures. – Serves as a liaison for Quality Control with regulatory agencies and external sources regarding issues impacting licensure of the facility. – Directs and participates in continuous quality improvement efforts to conform to regulatory requirements and industry standards by enhancing quality control systems. – Serves on internal project teams to shape the direction and influence the effectiveness of meetings and actions based on extensive knowledge of regulatory requirements, industry standards, company strategy and laboratory technical implications. – Exerts influence in the development of objectives and long-range goals of the organization. Builds and maintains strong, collaborative partnerships with others across various company functions. – Uses scientific expertise to provide assistance to coworkers with troubleshooting, laboratory investigations and problem resolution. – Aids in process improvements where applicable. – Evaluates, coaches and manages personnel performance. – Monitors group spending to remain on track with budget. – Assertive in work interactions, leading by example and building collaborative relationships. Builds a strong, team that is reliable, responsive and flexible to shifting demands. – Ability to effectively represent the company during interactions with FDA and other regulatory officials, demonstrating credible and substantial QC Microbiology expertise. – Build an exceptional team to support Junos Corporate Quality and Compliance function. BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . 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