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