Supervisor Manufacturing

Sanofi•Framingham, MA
•Onsite

About The Position

The Manufacturing Supervisor will work in a new large-scale cGMP biologics facility that includes solution preparation, equipment preparation, upstream operations, and downstream operations. During plant start-up, the role will perform a diverse range of manufacturing activities from Operational Commissioning/Shakedown through process validation (PV) and Product Change Over. After PV runs, the primary function will be to support operations, with additional support for upstream and downstream operations as needed. Under general guidance, the supervisor performs complex manufacturing tasks in accordance with manufacturing instructions and current GMPs. The role leads and develops staff, oversees production activities and schedules, maintains compliance and inspection readiness, and works with Manufacturing Management, Quality, project teams, and other functions to resolve operational issues and deliver continuous improvement.

Requirements

  • High school diploma/GED with 5–10 years of experience in a cGXP environment, or a bachelor's degree with 4–8 years of experience.
  • At least 1 year in a lead or supervisor role.
  • Prior experience in cGMP manufacturing operations.
  • Demonstrated ability to coach and train employees effectively.
  • Ability to lift up to 50 pounds.

Responsibilities

  • Select, develop, and motivate qualified staff to carry out department functions and maintain continuity of supervisory and specialized skills.
  • Provide leadership, guidance, and direction consistent with cGMP and corporate quality governance.
  • Coach and mentor staff on 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 affecting subordinate employees.
  • Establish key performance indicators and maintain and report applicable department or organizational metrics.
  • Represent the business unit in project team meetings related to global initiatives.
  • Interact with project teams and research groups where they impact quality operations.
  • Perform internal audits of SOPs and documentation related to QS Enterprise Systems and other functions receiving CQO QA oversight.
  • Lead and implement continuous improvement projects and ensure projects are completed on schedule.
  • Execute manufacturing activities in accordance with production batch records, SOPs, and cGMP.
  • Maintain a safe working environment and report incidents and accidents to Site Leadership.
  • Implement and maintain production schedules and adhere to site scheduling processes.
  • Ensure manufacturing personnel are trained for assigned functions and tasks and remain compliant with annual safety and cGMP training.
  • Partner with Manufacturing Managers and Quality to keep manufacturing areas inspection-ready.
  • Operate complex systems and equipment in accordance with production batch records, SOPs, and cGMP.
  • Use documentation control systems to author, review, and improve documentation.
  • Apply process knowledge and investigation skills to identify and resolve departmental issues.
  • Escalate production-floor issues concerning procedures, materials, processes, equipment, automation, utilities, or information systems to Manufacturing Management or the appropriate functional area.
  • Ensure personnel identify and document events that deviate from procedure.

Benefits

  • Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
  • At least 14 weeks of gender-neutral parental leave.
  • Employee benefit programs may be available to eligible employees.
  • Rewards package recognizing employee contributions.
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