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R&D Manufacturing Technician

Company: Sanofi
Location: Framingham
Posted on: June 6, 2021

Job Description:

Position Overview:

Clinical Injectables Manufacturing is responsible for producing Phase 1 and 2 clinical drug products as part of the R&D CMC organization.

Key Responsibilities:

The R&D Manufacturing Specialist is responsible for running the fill and finish line and producing final drug product. The work schedule is Monday through Friday, first shift with occasional weekend work required with core duties as follows:

  • Prepare and run filling line for vial and syringe filling operations.

  • Perform daily process activities in compliance with standard operating procedures (SOPs).

  • Initiate SOPs, User Requirements, Deviations and Change Controls.

  • Prepare all process specific equipment for use in assigned areas.

  • Operate equipment in compliance with SOPs.

  • Assure compliance with cGMP (current Good Manufacturing Practices) requirements.

  • Complete and review associated production records.

  • Assist in the onboarding of new team members.

  • Cross train on final product inspection.

Basic Qualifications:

  • High School diploma/GED or Biotechnology certificate with a minimum of 5 years of experience in cGMP manufacturing environment or a Bachelor's degree with a minimum of 3 years of experience.

  • Experience with aseptic processing, including fill/finish.

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

  • Excellent communication skills time management, and organizational skills are essential to success in this role.

  • Experience in writing SOPs.

Preferred Qualifications:

  • Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.

  • 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.

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-SA

#LI-SA

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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Keywords: Sanofi, Framingham , R&D Manufacturing Technician, Other , Framingham, Massachusetts

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