GMP Drug Product Clinical Manufacturing Operator

Job title: GMP Drug Product Clinical Manufacturing

Location: Framingham, MA

Join the engine of Sanofi’s mission where deep immunoscience meets AI-powered research. In R&D you’ll drive breakthroughs that could turn the impossible into possible for millions.

This is a manufacturing technician position in the Injectables Manufacturing group, part of the R&D Biologics Development organization. The group produces Phase 1, 2 and 3 clinical drug product, and the major accountability for this position is to run the fill‑and‑finish line, producing final drug product. All activities are closely supervised and reviewed upon completion. The work schedule is Friday through Tuesday, first shift required.

For the first 3 months, the person will train on a Monday‑through‑Friday first shift schedule and then transition to support weekend work.

• Perform pre‑run/setup activities including equipment preparation, CIP and cleaning cycles, VHP, pre‑use and post‑use filter integrity tests and visual inspection activities.
• Prepare and run filling line for vial and syringe filling operations.
• Perform daily process activities in compliance with standard operating procedures (SOPs).
• Prepare all process‑specific equipment for use in assigned areas.
• Operate equipment in compliance with SOPs.
• Assure compliance with cGMP requirements (current good manufacturing practices).
• Complete and review associated production records.
• Cross‑train on final product inspection.

• Biotechnology certificate or Associate’s degree in biology/chemistry with at least 2 years of experience in a cGMP manufacturing environment.
• Experience with aseptic processing.
• Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.
• Excellent communication and collaboration skills.
• Experience in writing SOPs.

• Biotechnology certificate or Associate’s degree in biology/chemistry with at least 5 years of experience in a cGMP manufacturing environment.
• Bachelor’s degree with at least 2 years of experience in a cGMP manufacturing environment.
• Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.
• Strong verbal and written communication, effective time management, and organizational skills.
• Must be self‑motivated, detail‑oriented, able to manage own time, flexible, team‑oriented, and demonstrate good troubleshooting skills.
• Visual inspection experience.

• Visual acuity of 20/30 near vision with or without correction required.
• Ability to lift up to 50 pounds.
• Push/pull up to 50 pounds to move loaded, wheeled carts with assistance from another worker.
• Frequent sitting, walking, standing, bending and squatting.
• May require standing and walking up to 70% of the day.
• Frequent reaching between waist and shoulder level.
• Occasional reaching up and out.
• Repetitive grasping and movement of hands and fingers.
• May involve work with hazardous materials.

• 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 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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, sexual orientation, disability, veteran or 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.

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.