Sanofi Group Manufacturing Supervisor in Framingham, Massachusetts

Manufacturing Supervisor

Description

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.

DEPARTMENT DESCRIPTION:

The Cell Culture Operations Department performs small and large scale cell culture operations, media preparation, equipment preparation, clean in place (CIP) and steam in place (SIP), and Preventative Maintenance of process equipmentas part of a 24/7 large-scale therapeuticprotein manufacturing facility.

**POSITION OVERVIEW/KEY RESPONSIBILTIES\

  • :**

Position Summary

The Manufacturing Supervisor is responsible for managing a manufacturing team and leading the manufacturing floor operations including execution to procedures and schedule, personnel training, and containment/escalation of issues and deviations both within manufacturing and to support functions.

Core Responsibilities

Personnel Management

  • Maintains a safe working environment and reporting 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 and/or electronic batch records, standard operating procedures and cGMP.

  • Manages 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 performance.

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

  • Provides working knowledge and technical leadership in cell culture, bioreactor operations, automation system (DeltaV).

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 and automation issues.

Deviation Management

  • Ensures manufacturing staff identifies, escalates and document events that deviate from normal operation; supports deviation investigations.

  • Partners with Quality Assurance to identify events that are deviations and completes event record.

  • Completes investigations, reports, and proposes CAPA for minor deviations.

  • Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical 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 supporting plant floor continuous improvement initiatives.

  • Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.

* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

LEADERSHIP QUALIFICATIONS:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue 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.

  • Beinghonest and treating people with respect and courtesy.

  • Constantly striving to make Genzyme 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 andexercising sound judgment in performing our jobs.

Leading People

  • Genzyme'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

  • Genzyme'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

  • Genzyme'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.

The Cell Culture Operations Department performs small and large scale cell culture operations, media preparation, equipment preparation, clean in place (CIP) and steam in place (SIP), and Preventative Maintenance of process equipmentas part of a 24/7 large-scale therapeuticprotein manufacturing facility.POSITION OVERVIEW/KEY RESPONSIBILTIES\

  • :Position SummaryThe Manufacturing Supervisor is responsible for managing a manufacturing team and leading the manufacturing floor operations including execution to procedures and schedule, personnel training, and containment/escalation of issues and deviations both within manufacturing and to support functions.Core ResponsibilitiesPersonnel Management

  • Maintains a safe working environment and reporting 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 and/or electronic batch records, standard operating procedures and cGMP.Manages 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 performance.Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s).Provides working knowledge and technical leadership in cell culture, bioreactor operations, automation system (DeltaV).Training/ComplianceSchedules 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.ProductionOperates 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 and automation issues.Deviation ManagementEnsures manufacturing staff identifies, escalates and document events that deviate from normal operation; supports deviation investigations.Partners with Quality Assurance to identify events that are deviations and completes event record.Completes investigations, reports, and proposes CAPA for minor deviations.Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical deviations.Continuous ImprovementContributes 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 supporting plant floor continuous improvement initiatives.Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.\

  • Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needsLEADERSHIP QUALIFICATIONS:An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue 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.

  • Beinghonest and treating people with respect and courtesy.

  • Constantly striving to make Genzyme 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 andexercising sound judgment in performing our jobs.Leading People

  • Genzyme'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

  • Genzyme'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

  • Genzyme'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.

Qualifications

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 50lbs

PREFERRED QUALIFICATIONS

  • Demonstrated ability to effectively coach and train employees.

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

  • 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-trainings, and other controlled

Job: Production

Primary Location: United States-Massachusetts-Framingham

Job Posting: Aug 22, 2016, 11:47:02 AM

Job Type: Regular

Employee Status: Regular