Head Of Process Chemistry For Small Molecules

Sanofi Waltham , MA 02154

Posted 2 months ago

Head of Process Chemistry for Small Molecules

Sanofi's CMC organization is seeking a Head of Process Chemistry for Small Molecules based in the US. Managing about 30 people with a direct impact on a significant amount of CMC development activities and cost.

Key Responsibilities:

  • Develop and lead integrated teams to identify and develop safe, environmental-friendly, cost-effective and efficient drug substance synthesis routes for commercial manufacturing processes (NDA route) for Sanofi's First in Class and Best in Class R&D programs.

  • Apply cutting-edge chemistry, incl. biocatalytic reactions, for inventing new and efficient syntheses routes fit for continuous chemistry, highly competitive with respect to optimized synthetic pathways starting with commodity raw materials and in line with a full green chemistry approach.

  • Use and further develop technologies as e.g. Automation, High Throughput Experiments, Biocatalytic Reactions, Data Modeling

Strategic:

  • Contribute strategically and operationally to the development projects of new entities as functional head, providing with the team strategic inputs and resources as well as securing the project deliverables.

  • Strongly collaborate with Project Management heads in charge of the CMC project leadership of small molecules development projects

  • Build flexibility to act on First in Class and Best in Class project acceleration project needs

  • Foster innovation from ideation to industrial development and manage a solid scientific network internally and externally

  • Promote and collaborate within the digitalization program

Scientific:

  • Drive all activities for Small Molecules from Proof of Concept to Submission/Industrialization for:

  • NDA route ideation

  • NDA route feasibility

  • NDA route development together with Process Development and Process Engineering groups

  • Biocatalysis

  • Industrialization

  • Activities to be covered

  • Chemical route ideation, route design and feasibility studies

  • Chemical route development and optimization

  • Organic synthesis design, using e.g. retrosynthetic tools

  • High Throughput Experiments and robotics

  • Data Modeling

  • Understand the impact of Drug Substance properties for DP formulation (physical quality alignment between DS and DP) and Analytical Development, within the Pharmaceutical Platforms as well as with all CMC and commercial manufacturing functions relevant to the deliverables (quality, supply chain, dossier, etc).

  • Drive Sanofi's reputation in the field of synthetic chemistry through record of publications, presentations and patents

Operational:

  • Collaborate with pharmaceutical development teams to define and characterize the Physical Quality of the drug substance to maximize both drug substance and drug product processability and performance

  • Lead teams in a global network within the CMC organization

People:

  • Establish and develop teams mastering cutting edge chemistry technologies such as High Throughput (early screening and late optimization), biocatalytic route scouting, flow/continuous process design, and datamining

  • Foster the innovative mindset within the teams

  • Collaborate with peers within and outside of CMC for people development

  • Continuously Improve the technical and scientific capabilities of the department by training, job rotations, investing in new technologies and skills

Qualifications:

  • PhD in Chemistry or related field with a minimum of 13 years of experience in the pharmaceutical industry and/or academia

  • Minimum of 5 years experience managing teams of high-level scientists

  • Strong scientific track record at least in one of these fields: organic chemistry route scouting, biocatalytic reactions, high throughput experimentation

  • Advanced scientific network within Academia and Industry

  • Experience in developing products all the way to NDA submission and approval

  • Ability to create a vision, develop a strategy, align resources and management, execute and adapt as needed to achieve short and long-term goals

  • Solid understanding of CMC aspects of drug development and related functions, including analytics, physical quality and formulations

  • Demonstrated technical, project management and organizational skills; ability to work in a matrix organization

  • Track record of publications and patents

  • Ability to take initiative and show creativity in proposing, developing and executing ideas

  • Willingness to encourage experimentation, educated risk taking and learning from failure

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.

#GD-SA

#LI-SA

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.

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Head Of Process Chemistry For Small Molecules

Sanofi