Associate Director, Process Engineering

Location: Cambridge, MA

About the Job

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are seeking a highly motivated individual with a mindset to lead the implementation of changes. The successful candidate will be recognized as a technical expert in the field of drug substance process development and will have leadership experience. They will work in a cutting-edge scientific global Drug Substance Process Development department in Sanofi's R&D CMC Synthetic organization. The position is based in Cambridge, MA, with close collaboration with colleagues in France.

Our Drug Substance Process Development team works cross-functionally to develop robust, scalable, and efficient processes for the synthesis of active pharmaceutical ingredients (APIs). This includes work on reaction optimization, process intensification, and the development of both batch and continuous manufacturing processes. The role spans from candidate selection through commercial launch. We strongly believe that innovation in process development, data science, and modeling will be key drivers to transform pharmaceutical process development.

Main Responsibilities:

• Lead a team that collaborates with internal partners in Process Chemistry Development, Drug Product and Crystallization to develop comprehensive API manufacturing processes. This includes assessment of synthetic routes, process scalability, process characterization and overall manufacturability.
• Develop and mentor others to create processes that consistently produce APIs 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 from traditional data-driven statistical approaches to more efficient and effective Digital Development methodologies.
• Domain Knowledge: Apply a strong background in Chemical Engineering and Process Chemistry to understand and implement strategies to control API synthesis, including reaction kinetics, thermodynamics, and process analytical technology (PAT).
• Experimentation: Utilize strong lab skills to deliver well-designed, efficient experimental plans required for process development across a wide range of reaction and separation equipment.
• Analytical: Perform physicochemical analysis to understand processes and characterize products. This includes but is not limited to HPLC, GC, NMR, MS, and various spectroscopic techniques.

• Dedicate part of the time to continuous improvement, either with internal resources or through academic collaborations. Potential areas include:

• Development of kinetic models to understand and optimize reaction pathways and impurity formation.
• Create process models (Digital Twins) for batch and continuous processes, using tools like gPROMS for identifying Critical Process Parameters (CPPs), Design Space, and Control Strategies.
• Identify and test Process Intensification approaches to improve API synthesis efficiency and quality.

• Author publications, patents, and present at technical conferences.
• Lead tech transfer of drug substance processes to 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 networks 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, Chemistry, or related field with a minimum of 6 years of experience, or Master's degree with a minimum of 10 years of experience in academia or industry.
• Proven track record in developing and leading others to develop drug substance processes.

•  Modeling experience using gPROMS, DynoChem, Matlab, Python, or similar programming languages.
•  Ability to work as part of a team, engaging other scientists with complementary skill sets in pharmaceutical development.
• A change agent mentality, proposing novel approaches to challenging scientific questions and exploring new modeling approaches.
• Ability to design and deliver lab experimental plans for process development, including use of typical process and analytical equipment.
• Familiar with PAT and common analytical techniques such as HPLC, GC, and NMR.

Preferred Qualifications:

• Knowledge in Multivariate Analysis, chemometrics, and statistics.
• Experience in the development and scale-up of continuous processes.