Success Profile

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Results-driven
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Leadership
Team player

Manufacturing Supervisor (Downstream)

Department Description

8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products. This is a Downstream manufacturing position. Purification experience is strongly preferred.

WHO WE ARE:

Sanofi 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 compassion and commitment of our employees. Sanofi’s portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. Sanofi benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a commitment to improving the lives of patients.

WHERE WE ARE:

Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service.

Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations. Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.

WHAT WE DO:

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 and emerging markets.

CORE RESPONSIBILITIES:

Personnel Management

• Maintain a safe work environment and report incidents/accidents to site leadership.

• Assigns daily duties and tasks to all team members and ensures execution of manufacturing activities in strict accordance with production batch records, standard operating procedures and cGMP.

• Manages and developing the performance of direct reports by setting goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for performance.

• Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, utilities, and/or information systems to Manufacturing and/or appropriate functional area management.

• Provides working knowledge and technical leadership in Purification operations.

Training/Compliance

• Schedules and/or delivers training to manufacturing personnel in accordance with Department Training Plan to ensure staff can perform manufacturing operations correctly, safely and compliantly.

• Partners with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times.

• Promotes “Right First Time” philosophy for all manufacturing activities.

Production

• Operates complex systems and equipment in strict accordance with production batch records, standard operating procedures and cGMP.

• Performs batch record review.

• Supports and adheres to site scheduling processes.

• Demonstrates ability to troubleshoot basic mechanical issues.

Deviation Management

• Ensures manufacturing staff identify and document events that deviate from normal operation; Supports deviation investigations.

• Partners with Quality Assurance to identify quality events and complete event records.

• Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical manufacturing owned deviations.

Continuous Improvement

• Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear. Review and refine the current document periodic review process to ensure that all manufacturing documents are accurate and revised as necessary.

• Manages or supports plant floor continuous improvement initiatives.

• Represents Manufacturing in Project Team meetings and department initiatives.

• Maintains an ongoing commitment to conducting business according to the highest legal and ethical standards, and continually pursues excellence in the development and delivery of all of our products and services.

This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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 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 while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

BASIC QUALIFICATIONS:

• High School diploma/GED with 6-10 years of experience in a cGXP environment, or a Bachelor’s degree with 4-8 years of experience.

• 1 year in a lead or supervisor role.

• Must have prior experience in cGMP manufacturing operations.

• Ability to lift up to 50 lbs

PREFERRED QUALIFICATIONS:

• Bachelor’s degree with 5-9 years of experience in bulk biologics GMP manufacturing and 2+ years of experience leading manufacturing teams.

• Demonstrated ability to effectively coach and train employees.

• Extended experience in large-scale chromatography.

• Training, coaching, leadership experience.

• Experienced leading manufacturing teams to maintain adherence to a demanding production schedule.

• Experienced facilitating meetings.

• Experienced authoring and reviewing standard operating procedures, on the job-training's, and other controlled documents.

• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.

• Experienced in managing direct reports.

LEADERSHIP QUALIFICATIONS:

• Able to work with and lead cross functional teams through complicated processes in a Quality system

• Capable of effective and clear communication that enables teams to execute on key deliverables

• Experience coaching teams through regulatory inspections

Sanofi Inc. 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; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.