Principal Research Associate, Cell Therapy Process Development

Job description

Position Overview/Department Description   

The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products.

The Gene Therapy Process Development group in 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 in the Cell Therapy field. The successful candidate must have deep scientific knowledge and hands on experience in cell therapy process and analytical development. The candidate must be highly motivated, independent, collaborative, and able to communicate effectively with a cross-functional team.

Key Responsibilities:  

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Investigate gene editing approaches for primary human cells

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Design (DOE), plan, and execute process development experiments and troubleshoot existing protocols to increase process performance as measured by editing efficiency, process robustness and final product yield.

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Develop assays towards characterizing edited populations of human primary cells

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Work with R&D to implement research findings and assay development into manufacturing processes

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Write protocols and operating procedures for technology transfer

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Perform FMEAs, process and project risk assessment

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Author process development and characterization reports

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Analyze experimental data and provide statistical inferences to identify CPPs, CQAs

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Oversee and quality check study designs, data, and results of external partners

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Perform data analyses, contribute to technical reports, protocols and internal/external presentations

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Stay updated on new, relevant technologies and published literature to drive innovation within the group

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Mentor and support junior staff as needed

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Willingness to work in a Biosafety Level 2 environment

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Occasional weekend and holiday work to support ongoing lab activities

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Availability to travel (~15% of time, primarily domestic)

Basic Qualifications   

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Bachelor’s degree in biological sciences or related discipline with a minimum of 4 years of relevant industry experience or a Master’s degree with a minimum of 2 years of relevant industry experience

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Knowledge of cGMP manufacturing and process development/validation

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Tech transfer experience and partnering with a CMO/CRO

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Scale-up manufacturing experience

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Extensive experience with primary cell culture, expansion, transfection, formulation and common immunological assays such as proliferation, cytokine FACS and ELISA, and multiplex assays

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Understanding of gene editing (ZFN/TALEN/Crispr) technologies.

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Experience with isolation of primary cells from peripheral blood

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Knowledge of cGMP manufacturing and process validation

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Excellent organizational, record keeping, oral and written communication skills.

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Team player, detail oriented and organized

Preferred Qualifications

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Self-directed and motivated individual and commitment to meet aggressive timelines 

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Excellent organization and written communication skills, committed to internal documentation practices 

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Ability to communicate and represent group in diverse, multi-functional meetings

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Ability to work on multiple tasks simultaneously 

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Able to work under minimal supervision and function within a collaborative/team-oriented environment  

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Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency 

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Experience in mentoring junior staff for training and understanding of process performance

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Innovative, critical and creative thinker, unafraid to propose aggressive solutions to complex problems

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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