COMPLETE Manufacturing Associate - Framingham, MA

This role is to support clinical manufacturing, as a cell therapy manufacturing specialist in Framingham, MA.  

This is a 2nd shift position working 3:30pm to 2:00am (Wed-Sat) that will require some weekend and or late shift work (schedule-dependent).   

Key Responsibilities:
 

• Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines.  

• Participates in On-the floor participation of upstream and/or downstream activities for executing manufacturing campaigns in a multi-product GMP facility Follows standard operating procedures and/or batch documents to execute activities. 

• Assists with adapting new and existing equipment to new processes developed for each drug candidate 

• Participates on cross functional teams and drives investigation close outs, determines root-cause and implements appropriate Corrective and Preventative Action.  

• Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.  

• Assists with document revisions and/or document management including batch production records, and manufacturing procedures.  

• Authors or revises standard operating procedures to improve compliance and efficiencies. 

• Assists manufacturing managers and supervisors to develop and maintain training materials on process operations, theory, and compliance.  

• Performs training with staff on the floor, as needed.  

• Participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.  

• Works under general supervision and direction.  

• Participates in determining objectives of assignment.  

• Performs work that may require independent decision making and the exercise of independent judgement and discretion.  

Basic Qualifications:

• High school diploma/GED or Biotech Certification with 3-5 years of experience in cGXP manufacturing environment, or Bachelor’s Degree with 1-3 years of experience.  

• Knowledge of Cell Therapy manufacturing.  

• Understanding of GXP and how it applies to specific responsibilities.  

• Excellent written and oral English language skills. 

Preferred Qualifications:

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, or Chemical Engineering with 1-3 years of experience.  

• Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents.  

• Familiarity with Controlled document systems.  

• Experience operating in gowning and clean room environments 

• Experience in troubles shooting investigation, and root cause analysis in a GXP environment.  

• Experience with deviation or investigation management systems. 

Special Working Conditions:

• Ability to gown and gain entry to manufacturing areas.  

• Ability to lift 30 lbs. 

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.

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