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Scientist – Cell Therapy Process Development

Waltham, Massachusetts



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The Genomic Medicines Unit within Sanofi is seeking an experienced scientist / engineer to join our Cell Therapy team that is highly focused on the rapid development of new therapeutic treatments. The successful candidate must have deep scientific knowledge and hands on experience in cGMP manufacturing, cell therapy process and product development. The candidate must be highly motivated, independent, collaborative, and able to communicate effectively with a cross-functional team.

Key Responsibilities:

  • Design (DOE), plan, and execute process development experiments and troubleshoot existing protocols to increase process performance as measured by process robustness and final product characteristics.
  • Develop assays towards characterizing the manufacturing process. 
  • Work closely with research teams to implement findings and assay development into manufacturing processes
  • Write protocols and operating procedures for technology transfer
  • Work closely with CMO’s/CDMO’s
  • Perform FMEAs, process and project risk assessments
  • Author process development and characterization reports
  • Analyze experimental data and provide statistical inferences to identify CPPs, CQAs
  • Oversee and quality check study designs, data, and results of external partners
  • Perform data analyses, contribute to technical reports, protocols and internal/external presentations
  • Represent platform innovation at inter-departmental meetings and workstreams
  • Stay updated on new, relevant technologies and published literature to drive innovation within the group
  • Mentor and support junior staff as needed
  • Occasional weekend and holiday work to support ongoing lab activities
  • Occasional travel up to 20%

Basic Qualifications:

  • PhD in biological sciences or Masters degree in biological sciences and a minimum of 4 years of relevant experience or a Bachelors degree in biological sciences and minimum of 6 years of relevant experience
  • Knowledge of cGMP manufacturing and process development/validation
  • Tech transfer experience and partnering with a CMO/CRO
  • Scale-up manufacturing experience
  • Extensive experience with immune cells, preferably NK cells, including culture, expansion, transfection, formulation and common immunological assays such as proliferation, cytokine FACS and ELISA, and multiplex assays
  • Experience with gene editing (ZFN/TALEN/Crispr) technologies.
  • Experience with isolation of human primary cells from peripheral blood
  • Knowledge of cGMP manufacturing and process validation
  • Excellent organizational and communication skills
  • Able to work independently and function within a collaborative/team-oriented environment

Preferred Qualifications:

  • Innovative, critical and creative thinker, unafraid to propose aggressive solutions to complex problems
  • Experience in mentoring junior staff

Special Working Conditions:

  • Required to work in a Biosafety Level 2 environment

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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