Principal Scientist Crystallization

Job Title: Principal Scientist Crystallization

Position Overview/Department Description:

We are looking for a highly motivated individual with a mindset to implement changes. She/He will be recognized as technical expert in the field of crystallization and solid-state chemistry. 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:

• Work 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)
• Development of processes to consistently produce API with the required quality attributes using both batch and continuous platforms.  Expectations include;
  • Team Interactions – Integrate closely 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 – Apply AI/Modeling to transform 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. 

Basic Qualifications:

• PhD in Chemical Engineering, Solid State Chemistry or Physical Chemistry with a minimum of 4 years experience in industry or academia, a master’s degree with a minimum of 8 years of experience or a bachelor’s degree with 12 years of experience.
• PhD in other related field such as Pharmaceutical Science or Organic Chemistry will also be considered if the candidates work experience is relevant to the job requirements.
• Proven track record in crystallization development.
• An ability to work as part of a team, engaging other scientists with complementary skill sets in the field of pharmaceutical development.
• A change agent mentality, proposing novel approach to challenging scientific questions and exploring new modeling approaches.
• Ability to design and deliver lab experimental plans for crystallization process development including use of typical process and analytical experiment.

Preferred Qualifications:

• Familiar with PAT and common off-line analytical technics such as HPLC, GC and NMR
• Modeling experience using gPROMS, DynoChem, Matlab, Python or similar programming languages.
• Some knowledge in Multivariate Analysis, chemometrics and statistics
• Experience in the development and scale-up of continuous processes

Additional Comment (if any):

Domestic and international travel may be required (5-10%).

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!