Associate Director Crystallization

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Position Overview/Department Description:

We are looking for a highly motivated individual with a mindset to lead the implementation of changes. She/He will be recognized as technical expert in the field of crystallization and solid-state chemistry and will have leadership experience. The successful candidate will work in a cutting-edge scientific global crystallization department in Sanofi’s R&D CMC Synthetic organization.  The job is in Cambridge MA, but close collaboration with colleagues in France is required.  Crystallization Scientists work cross functionally to select active pharmaceutical ingredients (API) solid forms for development and deliver robust commercial API crystallization processes.  Process development may be directed to either batch or continuous processes.  Collaborative work with Chemists and Engineers on complex drug substance intermediate crystallizations will also be required.  Work starts at candidate selection and continues to commercial launch.  We strongly believe that innovation in process development, data science and modelling will be key drivers to transform Pharma process development.

Key Responsibilities:

• Lead a team that works with internal partners in Drug Product development, Biopharmaceutics and Analytical to select the API physical form for new NCEs.  This includes assessment of the manufacturability (API solid form space complexity, physical properties, scalability, stability)

• Develop and mentor others to develop processes to consistently produce API with the required quality attributes using both batch and continuous platforms.  Expectations include;

  • Team Interactions – Facilitate close interactions with project team members such as Chemists, Analysts, Formulators and Engineers/Modelers to develop API processes that are closely coordinated with API route selection and Drug Product development. 

  • Digital Development – Lead the transformation of development from traditional data driven statistical approaches to more efficient and effective Digital Development.

  • Domain knowledge - Use a strong background in Crystallization Engineering and/or Solid-State Chemistry to understand and apply strategies to control API physiochemical properties such as particle size distribution, impurities concentration and crystal form.

  • Experimentation – Apply strong lab skills to deliver well designed efficient experimental plans required for process development across a wide range of crystallization, isolation and size reduction process equipment. 

  • Analytical – Perform physiochemical analysis to understand process and characterize products this includes but is not limited to XRD, DSC, PSD, SEM, optical microscopy, LC, GC, KF.

• The candidate will be expected to dedicate part of their time to work on continuous improvement with internal resource or through academic collaboration.  Some potential areas for improvement include;

  • Development of models to understand and describe the rejection of impurities in intermediate and API crystallizations. 

  • Develop crystallization models (Digital Twins) for batch and continuous process and use Global System Analysis tools (e.g. gPROMS) to identify CPPs, Design Space and Control Strategies.

  • Identify and test Particle Engineering approaches to improve API physical properties such as supersaturation control, seed conditioning and agglomeration.

  • Author publications, patents and present in technical conferences.

• Lead Tech Transfer of crystallization to the Pilot Plant and Manufacturing.  This includes support for technical and HSE risk assessments, review of Master Batch Records and campaign coverage for key batches.

• Provide concise technical presentations to communicate work to project teams, cross functional teams and management.  Document all work on projects and continuous improvements in eLNB experiments and summarize in Technical Reports. 

• Establish/extend external network by providing leadership on academic, industrial, or government sponsored collaborations.  Steer collaboration projects to address gaps in scientific knowledge. 

About you

Basic Qualifications:

• PhD in Chemical engineering or Solid State Chemistry or any related field with a minimum

  of 6 years of experience or Masters’ degree with a minimum of