Job Title: Manufacturing Supervisor

Location: Framingham, MA

Night Shift 12 Hour Rotation: 6:45 am - 7:15 am

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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 12 hour, rotating Night Shift position in a flexible, single-use technology, large scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations.

The Manufacturing Supervisor (Night Shift) will be 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• 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 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 respective area.
• Cross train personnel within multiple departments and provide employee feedback to management.

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 identify and document events that deviate from normal operation; supports deviation investigations.
• Partners with Quality Assurance to identify events that are deviations.
• Supports 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 manufacturing owned deviations.

Continuous Improvement

• Contributes to continual improvement of all manufacturing documentation (SOP’s, EWI’s, MBR’s, OJT’s) to ensure they are current, accurate, and clear.
• Manages or supports plant floor continuous improvement initiatives.
• Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.

About You

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.

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.
• Demonstrated ability to effectively coach and train employees.

Preferred Qualifications

• Bachelor’s degree with 5-9 years of experience in bulk biologics GMP manufacturing and 2+ years of experience leading manufacturing teams.
• Training, coaching, leadership experience.
• Experienced leading manufacturing teams to maintain adherence to a demanding production schedule.
• Experienced facilitating meetings.
• Experienced authoring and reviewing batch records, standard operating procedures, on-the-job-trainings, and other controlled documents.
• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
• Experienced in managing direct reports.

Special Working Conditions

• Ability to lift up to 50 lbs.
• Ability to stand on average 10 hours per shift.
• Ability to gown and gain entry to manufacturing areas.
• Ability to work a twelve hour rotating night shift and every other weekend, including holidays as scheduled.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

#GD-SG

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.