GMP Drug Product Clinical Manufacturing Operator

Job title: GMP Drug Product Clinical Manufacturing

Location: Framingham, MA

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, 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 which is part of the R&D Biologics Development organization.  This group is responsible for producing Phase 1, 2 and 3 clinical drug product.  The major accountability for this position is to run the fill and finish line, producing final drug product. All activities are closely supervised and work is reviewed upon completion. The work schedule is Friday through Tuesday, first shift work required. For the first 3 months, the person will be training for the job on a Monday thru Friday 1st shift schedule and then transition to support weekend work.

About Sanofi 

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main Responsibilities:

• 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 among others.

• 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

About You

Basic Qualifications:

• Biotechnology certificate or Associates degree in biology/chemistry with a minimum of 2 years of experience in 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

Preferred Qualifications:

• Biotechnology certificate or Associates degree in biology/chemistry with a minimum of 5 years of experience in cGMP manufacturing environment.

• Bachelor's degree with a minimum of 2 years of experience in cGMP manufacturing environment.

• Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

• Strong verbal and written communications, effective time management, and organizational skills are essential to success in this role.

• Must be self-motivated, detailed oriented, have the ability to manage own time, be flexible, team oriented, and demonstrate good troubleshooting skills.

• Visual inspection experience

Special Working Conditions:

• 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 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

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 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; 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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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.