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Associate Director Cell Therapy Process Development

Principia Biopharma, Inc.

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Waltham, MA
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Job Description

As posted by the hiring company

Job Overview:

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. Sanofi is looking for an experienced cell culture development professional with experience in cell therapy process development to join the GMU Cell Therapy Process Development (CTPD) group located in Waltham, MA in the role of Associate Director. The GMU CTPD group within Sanofi operates with the mission to develop robust, scalable, and innovative cell culture processes for Sanofi’s genomic medicine pipeline.

This role is responsible for leading a team of scientists and responsible for the development of cell therapy processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing activities. We are looking for a candidate with excellent scientific, communication, and project management skills.

Job Duties and Responsibilities

  • Lead a team responsible for the development of cell therapy related cell culture processes, and technology transfer to manufacturing sites,

  • Makes strong technical, strategic contributions to cross functional development project teams

  • Oversee the process development and scale-up operations, defining scale down models and authoring associated regulatory filing activities

  • Responsible for successful cell therapy process development, process characterization and execution of manufacturing processes

  • Management of a multi project development portfolio

  • Lead projects to develop and implement industry leading cell therapy technologies

  • Drive innovation to enhance process productivity and quality

  • Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences

  • Author manuscripts and patent applications

  • Build strong interfaces internally with the CMC community and help drive adoption of best practices

Basic Qualifications

  • PhD degree in Biotechnology, Biology/Cell Biology, Biochemistry, Immunology, Chemical Engineering, or related discipline with a minimum of 8 years of relevant experience or a Master's or Bachelor's degree with a minimum of 12 years of relevant experience

  • Experience in the biotech/pharmaceutical industry within a cell culture role

  • Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.

  • Understanding of the theory and practice of cell culture process development

  • Strong background in cell culture bioreactor operations and scale up technologies

  • Minimum of 5 years of experience managing direct reports or project teams

  • Excellent communication skills

Preferred Qualifications

  • Experience managing cross functional team and initiatives

  • Understanding of immunology

  • Experience in immunology, flow cytometry, and gene editing technologies

  • Allogenic cell therapy experience

  • Expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology

  • Experience in primary cell and/or tissue cryopreservation

  • Understanding of regulatory guidance and requirements for cell therapy products

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.