Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.
With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Title:Director, Global Cell Banking
The Global Cell Banking Department is responsible for creating, maintaining and distributing Commercial (cGMP) Master and Working Cell Bank inventories to support commercial manufacturing across Genzyme manufacturing sites. The GCB group is responsible for all cGMP manufacturing activities related to cell bank production operations and maintenance of the cGMP manufacturing area. This includes all manufacturing activities, from equipment preparation to cell freeze down, all Quality and compliance related activities such as deviation and change control management and maintaining the production facility in a fully compliant and audit ready state at all times. The GCB lab is located in Framingham, Massachussetts.
- ManagementEnsure safety of manufacturing area and work practices in accordance with site Health, Safety and Environmental program.
- Manages group and area to meet all production requirements and maintain manufacturing area to highest standards of compliance.
- Recruits and manages staff to execute department functions; ensure effective utilization of resources through consistent performance management, and rewards and recognitions practices in area of responsibility.
- Provides leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards.
- Ensures that appropriate levels of trained resources are available to meet production schedules.
- Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to senior management and cross-functional support teams.
- Develops and maintains department budget.
- Drives and implements GCB strategic vision (technical, operational, organizational) in partnership with Senior Leadership.
- Establishes key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
- Works in close partnership with manufacturing sites to ensure seamless supply of cell banks as per production plans.
- Compliance / Training / Deviations
- Partners with Safety to ensure department Compliance with requirements from Genzyme's Safety Program including Health and Safety regulations and OSHA requirements.
- Ensures staff has appropriate knowledge of department processes and procedures and training to perform job responsibilities.
- Ensures manufacturing instruction set and production records reflect practice, are aligned to cGMPs and corporate standards.
- Ensures timely completion of investigations and deviations and CAPAs
- Utilizes quality metrics to measure, analyze, and improve team performance.
- Partner with QA to ensure the following:
- Real time batch review and "right first time".
- Ensures Inspection readiness of assigned manufacturing areas.
- Provides manufacturing approval of department documentation changes.
- Participates in inspections conducted by external regulators.Continuous Improvement
- Identifies opportunities to improve manufacturing processes and practices.
- Partners with cross-functional groups to troubleshoot and drive resolution of operational issues and proactively drive continuous improvement projects to completion.
- Oversees departmental projects and ensure appropriate controls, approvals, and validation requirements are implemented.
- 10+ years of experience in a cGMP Cell Banking and development environment
- CHO cell banking experience
- A minimum of a Bachelor's Degree in Biology or Life Sciences required,
- Master's preferred
- Basic understanding of Finance
- Standard Cost Knowledge & Experience is a plus
- Ability to motivate, coach communicate (written and oral), organize and lead people and projects.
- Proven leadership skills in the areas of communicating a vision for growth, motivating, challenging and mentoring employees.
- Experience leading manufacturing teams to maintain adherence to a demanding production schedule.
- Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation
- Strong documentation practices including batch production records, SOPs, OJTs and other controlled docuents.
- Familiarity with Deviation Management Systems (i.e. Trackwise).
- Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment.
- Experienced leading the implementation of improvements to technical and business processes.
- Experienced in managing direct reports whom have leadership responsibilities (supervisors and managers).
- Experienced in making tactical decisions on safety, process, scheduling and personnel-related issues
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