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Sanofi Group Supervisor Manufacturing in Framingham, Massachusetts

**7PM-7AM- rotating NIGHT SHIFT position including rotating holidays and weekends

*Will qualify for night shift differential*

**Bio/pharma experience

*People and process management skills*

*Strong operations experience*

Position in a cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations. Initial job responsibilities will include performing a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and Product Change Over.

The primary job function post PV runs will be Downstream Operations. Responsibilities will also include supporting Upstream and Support Operations as necessary. The Manufacturing Supervisor will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

Core Responsibilities

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of supervisory and specialized skills.

  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.

  • Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards, and disciplinary action.

  • Develop work plans, assign tasks, and supervise a large team or multiple small teams

  • Implement and administer policies and procedures that typically affect individual subordinate employees.

  • Establish key performance indicators, maintain, and report applicable department or organizational metrics.

  • Represent business unit in Project team meetings related to global initiatives.

  • Interact with project teams and research groups as they impact the quality operation.

  • Perform internal audits of the SOPs and documentation related to QS Enterprise Systems and other functions that receive CQO QA oversight.

  • Lead and implement continuous improvement projects.

  • Ensure projects are completed on schedule.

Additional Responsibilities

  • Ensure execution of manufacturing activities in strict accordance with production batch records, standard operation procedures, and cGMP.

  • Maintains a safe working environment and reporting of incidents/accidents to Site Leadership.

  • Implement and maintain production schedules.

  • Ensure manufacturing personnel are trained to perform all assigned functions and tasks.

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

  • Ensure manufacturing personnel are compliant with annual safety and cGMP training.

  • Operate complex systems and equipment in accordance with production batch records, SOPs, and cGMP.

  • Utilize documentation control systems to author, review, and improve documentation

  • Utilize process knowledge and investigation skill set to identify and resolve departmental issues.

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

  • Adhere to site scheduling processes.

  • Ensure personnel identify and document events that deviate from procedure.

Minimum Requirements

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

  • 1 year in a lead or supervisor role.

  • Must have prior experience in cGMP manufacturing operations.

  • Demonstrated ability to effectively coach and train employees.

  • Ability to lift up to 50 pounds.

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.

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