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.


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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

Training /Deviations/Compliance

  • 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

Continuous Improvement

  • 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

Leading People

  • 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


  • 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 (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

Job: Production

Primary Location: United States-Massachusetts-Allston

Job Posting: Oct 5, 2016, 8:56:31 AM

Job Type: Regular

Employee Status: Regular