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Global Head Synthetics CMC Development

Company: Sanofi
Location: Cambridge
Posted on: August 5, 2022

Job Description:

POSITION OVERVIEW:The fully integrated Global CMC Development function at Sanofi covers multiple modalities including biologics and small molecules; synthetic molecules, mammalian and microbially expressed proteins, as well as cell/gene therapy. Global CMC Development is a key enabler in Sanofi R&D s ambition. Their mission is to develop manufacturing processes, formulations, and analytical methods; scale up and manufacture clinical trial material; and lead/manage CMC teams clinical supply/demand management, and authoring/coordinating regulatory submissions.The Global Head of Synthetics CMC Development is a high impact and high visibility role that sits within CMC Development and reports to the Global Head of CMC Development. The individual will be responsible for all aspects of CMC activities for synthetic molecules, including chemistry route definition, API process development, formulation and DP development, analytical development, and testing, scale-up/technology transfer, clinical trial material production, and regulatory document authoring, from early research engagement with the medicinal chemistry group all the way through clinical development leading up to NDA submission and approval.With several exciting late-stage synthetic molecules and a steady stream of molecules from Sanofi research and in-licensing activities, this is an exciting time to lead this organization through successful development and approvals.KEY ACCOUNTABILITIES:The Global Head of Synthetics CMC Development will develop and execute strategies to efficiently progress the synthetics pipeline, and will be a member Global CMC Leadership Team. They will be responsible for a global organization (greater than 400 employees) with operations in France, US, and Germany, and hence may be in any of these locations.The individual will deliver Sanofi s synthetic molecule portfolio in close coordination with other Sanofi functions spanning from Research through commercialization. The scope of the role includes, Early Development (working closely with medicinal chemistry), Synthetic Chemistry, Process Chemistry using traditional and advanced technologies), such as continuous flow and bio-catalysis), Formulation and Final Dosage Development: Analytical Chemistry, Clinical manufacturing, and QC testing.KEY REQUIREMENTS:Serve our patients and deliver on Sanofi and R&D aspirations through the following Behavioral Competencies

  • Strategic: Define and execute functional strategy based on internal / external landscape
  • Result-Oriented: Demonstrate ownership in delivering results and creating value by ensuring team engagement, prioritized resource allocation, and delegation
  • People Leadership: Set aggressive goals and deliver by building an inclusive team with a feedback culture
  • Relationship and Influence: Engage with internal / external stakeholders by creating an inclusive environment based on trust and astute understandingBASIC QUALIFICATIONS:
    • PhD in Chemistry/Chemical Engineering or a related field.
    • At least 20 years relevant global industrial experience in a dynamic environment
    • Demonstrated experience of bringing multiple synthetic pharmaceutical products to global markets.
    • Experience managing one or more of the technical functions, i.e., Synthetic/Process Chemistry, Formulation, and Analytical Chemistry
    • Highly knowledgeable in all aspects of drug development with special emphasis on all aspects of CMC and a demonstrated history of innovation in the field of synthetics CMC
    • Growing list of peer-reviewed publications in the synthetic CMC field, including patents and conference presentations;
    • Highly knowledgeable in quality requirements and regulations as well as recent trends that govern synthetic molecule CMC development and NDA submissionsPREFERRED QUALIFICATIONS:
      • Experience of at least five years managing a team of 100 or more scientists/engineers. 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. 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. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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.

Keywords: Sanofi, Cambridge , Global Head Synthetics CMC Development, Other , Cambridge, Massachusetts

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