GMP Drug Product Clinical Manufacturing Operator

Sanofi•Framingham, MA

7d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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