Description
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments across several areas of medicine that have provided new hope for patients. Today, approximately 10, 000 Genzyme employees serve patients in nearly 100 countries. Genzyme's products are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. The company's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need. Genzyme is part of the sanofi-aventis Group. About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Responsible for managing a team of manufacturing specialists in the Upstream Operations Organization in the execution of projects supporting production and site goals.
Sr Manager Upstream Manufacturing
The Upstream Operation Department performs small and large scale cell culture operations, process equipment preparation, clean in place (CIP) and steam in place (SIP) of process equipment and the preparation/operation of microfiltration and chromatography systems in our Allston Landing Manufacturing Facility.
Additional Responsibilities include:
Management
Providing leadership and direction to Manufacturing Specialists and support teams while embodying the principles of the Genzyme Global Leadership Model Managing and developing the performance of direct reports by setting clear "SMART" goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance Ensuring timely issue escalation to manufacturing senior management and cross-functional support teams Ensure adherence to project schedules, while holding specialists responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet project schedules. Conduct performance appraisals and career development assessments for all direct reports.
Training/Deviations/Compliance Utilizing quality systems to measure, analyze, and improve team performance Participating in scheduling, MDI, project, and staff meetings, providing updates of department activities and project statuses. Partnering with Operations Manager:
o Designing Department Training Plan and managing execution.
o Ensuring Inspection Readiness of assigned manufacturing areas
o Oversees and participates in completion of investigations and deviations Complying with requirements from Genzyme's Safety Program including Health and Safety regulations and OSHA requirements
Production/Project Management Providing technical support and guidance as it impacts production processes and resolution of exceptions and investigations Overseeing departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented. Ensuring consistent department representation at project meetings, ensuring the needs of the department are considered throughout the life of the project. Provide clear communication regarding project plans, concerns, and updates to department management. Establish project plans designed to eliminate quality backlog, including CCRs, CAPAs, and Deviations. Design business processes intended to ensure that all quality events are completed in a timely manner. Monitoring projects through major milestones and completion. Obtaining additional resources from supporting departments as needed to be successful in the implementation of projects
Continuous Improvements Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner Identifying opportunities to improve manufacturing processes and practices Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate Partnering with Manufacturing Engineering to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process Partnering with Lean Organization to drive business process improvements through Kaizens, Kanban, 5S and VSM.
Qualifications
Basic Qualifications: Bachelor's or Associate's Degree with 9-11 years experience in a CGMP manufacturing environment 5 years leading direct reports Strong understanding of Quality systems Strong Project Management Experience
Preferred Qualifications: Bachelor's Degree Extended experience in Equipment Preparation, Cell Culture and Purification operations Training, coaching, and leadership experience Experienced leading manufacturing teams to maintain adherence to a demanding production schedule Experienced facilitating meetings Experienced working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents Familiarity with Deviation Management Systems (ie 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, compliance and personnel-related issues Ability to effectively and appropriately escalate operational issues Experienced in establishment of safe practices in a CGMP environment
Job: Manufacturing & Development
Primary Location: United States-Massachusetts-Allston
Shift: Day Job
Job Type: Regular
Employee Status: Regular |