Sanofi Group Sr. Manager Suite 1 Cell Culture in Allston, Massachusetts
Sr. Manager Suite 1 Cell Culture
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.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law
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 systems in our Allston Landing Manufacturing Facility.
POSITION OVERVIEW/KEY RESPONSIBILTIES\
Responsible for managing a manufacturing department consisting of supervisors and manufacturing harvest capture operators. Ensuring execution of production plan across multiple shifts and manages staff performance against operational goals.
Additional Responsibilities include:
Providing leadership and direction to Manufacturing Supervisors and support teams while embodying the principles of the Sanofi 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
Partnering with a Manufacturing Scheduler to ensure adherence to production schedules, while holding supervisors and teams responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet production schedules. Ensuring adherence to PM and validation schedules.
Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports
Utilizing quality systems to measure, analyze, and improve team performance
Leads scheduling, MDI, project, and staff meetings, providing updates of department activities and project statuses.
Partnering with Operations Manager to ensure the following:
Designing Department Training Plan and managing execution.
Ensuring Inspection Readiness of assigned manufacturing areas
Oversees and participates in completion of investigations and deviations.
Partnering with QA to ensure the following:
Real time batch review
Ensuring minor deviation are closed in a timely manner
Provides manufacturing approval for minor deviations and department documentation changes.
Ensures timely completion of CAPAs.
Participating in inspections conducted by external regulators
Complying with requirements from Sanofi’s Safety Program including Health and Safety regulations and OSHA requirements
Providing technical support and guidance as it impacts production processes and resolution of exceptions and investigations
Maintains Schedule Adherence
Overseeing departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented
Monitoring projects through major milestones and completion. Obtaining additional resources from supporting departments as needed to be successful in the implementation of projects
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.
- Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
LEADERSHIP QUALIFICATIONS: N/A if this position does not have direct reports
- Sanofi’s leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers
Leading the Business
- Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers
- Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals. They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance.
Bachelor’s or Associate’s Degree with 9-11 years of experience in a CGMP manufacturing environment
5 years leading direct reports
Strong understanding of Quality systems
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 (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
Ability to effectively and appropriately escalate operational issues
Experienced in establishment of safe practices in a CGMP environment
Primary Location: United States-Massachusetts-Allston
Job Posting: Oct 5, 2016, 8:56:31 AM
Job Type: Regular
Employee Status: Regular