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Sanofi Group Associate Director AD/QC Genomic Medicine Cellular Therapies in Framingham, Massachusetts

Position Overview:

This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Analytical Development/Quality Control (AD/QC) group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust AD/QC methods to support release and characterization testing of different cellular therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendia methods.

We are looking for a skilled and highly motivated scientist with broad expertise in immunology and cell-based assays to join the GMU AD/QC group. This group will be moving locations from Framingham, MA to Waltham, MA by June, 2022.

Key Responsibilities:

  • Lead multi-functional development team to establish and evolve current cellular therapy analytical methods and strategies.

  • Define broad technical objectives and champions pioneering analytical capabilities to enhance product function.

  • Troubleshoot existing protocols to increase method performance, throughput, and ergonomic control, evaluating novel technology platforms to advance and supersede existing capabilities and limitations.

  • Lead projects with complex interactions across, internally and/or externally.

  • Oversee the design, planning, and execution of complex methods and transversal projects, and performs deep data dives.

  • Work closely with process and analytical development teams, as well as manufacturing to identify analytical deficiencies and propose relevant and meaningful solutions for enhanced process understanding and control.

  • Support and/or lead manufacturing investigations and contribute to root cause analysis and correction action planning.

  • Manage documentation practices of the group reviewing study plans, reports, and operating procedures, as well as author and/or contribute to technical reports.

  • Actively investigate new technologies to complement improved product characterization and process control.

  • Oversee internal and external assay transfers consistent with established procedures, and ensure compliance to procedures.

  • Contribute to routine assay support as needed, following established procedures and group documentation practices.

  • Manage individual development plans and mentor staff for technical understanding and career growth.

Basic Qualifications:

  • PhD in a relevant discipline with a minimum 8 years of relevant industry experience or Master’s or Bachelor's degree in a relevant discipline with a minimum of 12 years of relevant industry experience.

  • Experience in developing cellular therapy specific analytical methods.

  • Experience developing methods with particular emphasis on immunology, cell-based, and analytical assays for cellular therapies.

  • Experience developing and implementing novel methods to improve process and product understanding with proven troubleshooting skills.

  • Understanding of cellular therapy regulatory guidance’s and ability to translate requirements to develop clinically relevant process control strategies and product attribute profiles.

  • Innovative, critical, and creative thinker.

  • Excellent organizational and communication skills.

  • Experience with direct reports or managing people in project-based or functional teams.

Preferred Qualifications:

  • Experience as an analytical development and/or quality control team leader for a gene or cell therapy project.

  • Experience in method transfers and gap analysis risk assessment processes.

  • Experience using QbD principles and tools e.g. DOE to develop analytical methods.

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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