Position Overview/Department Description

The Sanofi Genetic Medicine Unit CMC organization is responsible for the design and optimization of gene and cell therapy manufacturing processes and platforms. A key function of this group is to establish operational excellence in the manufacturing of Sanofi’s emerging portfolio of cellular therapy products. The bioanalytical group provides analytical testing to support in process, release, and stability testing, as well as development activities for process optimization and life cycle management from early to late-stage clinical entry.

The Research Associate is responsible for executing test methods under control of established procedures. Specifically, performing in-process and release testing of cellular therapies out of our 45 NYA manufacturing facility. Additional functions will include interpretation of data, preparation of test documentation, and management of analytical databases. We are looking for a candidate that is capable of learning quickly with the goal of executing analytical methods and managing assigned test schedules, with excellent communication skills. The position is located in Framingham, MA.

Key Responsibilities:

• Performing in-process and release testing of cellular therapies out of our 45 NYA manufacturing facility requiring occassional evening and weekend work
• Execute test methods following established procedures
• Manage test deliverables and training activities to defined test schedules
• Collaborate with colleagues to align on test requests
• Maintain compliance to test documentation completion and archiving
• Manage analytical databases and perform data analysis to support assay performance and control
• Maintain analytical infrastructure and supply/reagent inventories
• Contribute to assay investigations for out of expectation results or test failures
• Lead or support internal assay transfers from analytical development teams
• Author method procedures, and contribute to technical reports/memo’s
• Generate of materials for internal/external presentations as needed
• Participate in interdepartmental meetings and project specific sub-team meetings.

Basic Qualifications

• BS in biological sciences or related field
• Experience in an analytical setting executing methods/assays in a lab setting
• Excellent organization and documentation skills, and communication skills to provide a high level of customer service.

Preferred Qualifications

• 1 – 3 years of relevant experience in the life sciences, biotechnology, or pharmaceutical industry
• Basic knowledge and practical experience in cellular, molecular and chemistry analytical methodologies, including but not limited to flow cytometry, qPCR, ddPCR, HPLC, ITA, Potency assays, SDS PAGE, ELISA and others as applicable
• Practical experience in aseptic technique in a variety of cell line maintenance techniques is preferred
• Relevant knowledge of Cellular Therapy analytics methods is preferred, especially methods used to characterize cells by morphology, immunophenotypic markers, and potency assays
• Experience with automation technology platforms is highly desired
• Experience and knowledge of working with biohazard infectious agents is preferred.

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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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.