Principal Scientist, Drug Substance Process Engineering

Job Title: Principal Scientist, Drug Substance Process Engineering

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 looking for a highly motivated individual with a mindset to implement changes. She/He will be recognized as technical expert in the field of engineering. The successful candidate will work in a cutting-edge scientific global engineering department in Sanofi’s R&D CMC Synthetic organization. The job is in Cambridge MA, but close collaboration with colleagues in France is required. Engineers work cross functionally to develop robust commercial Drug Substance processes. Process development may be directed to either batch or continuous manufacturing. Collaborative work with Chemists and Engineers on complex drug substance intermediate crystallizations will also be required. Work starts during route selection and continues to commercial launch with engineering involvement increasing as development progresses. We strongly believe that innovation in process development, data science and modelling will be key drivers to transform Pharma process development.

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?

Main Responsibilities:

• 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 and Analysts to develop API processes.
• 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 Engineering to understand and apply strategies to control process quality, yield, cost safety and EcoDesign.
• Experimentation – Apply strong lab skills to deliver well designed experimental plans for process development across a wide range of unit operations.
• Analytical – Perform required physiochemical analysis to understand process and characterize processes this includes but is not limited to HPLC, GC, DSC, PSD, KF, optical microscopy and a variety of PAT techniques.

• Assist in the development and deployment of digital twins for batch and continuous processes ensuring alignment with Quality by Design (QbD) principles.
• Work closely with process Industrialization and New Technology Engineering team to design and implement model predictive control strategies for drug substance manufacturing processes.
• Implement Risk Assessments during development to ensure key processes quality and safety risks are identified and mitigated throughout development.
• Lead Tech Transfer of processes to the Pilot Plant and Manufacturing. This includes support for technical and HSE safety reviews, review of Master Batch Records and campaign coverage for key batches.
• Author relevant section of regulatory filings, help prepare for Preapproval Inspections, respond to question about regulatory filing and engage proactively with regulatory agencies through external engagement.
• 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

• PhD with minimum of 4 years of relevant industry experience or a Master’s degree with 8 years of relevant industry experience or a bachelors degree with 12 years experience.
• Proven track record in process development.
• Strong scientific track record in system models and process simulations
• Domain knowledge in small molecule with direct experience in either API or DP development or manufacturing
• Experience applying gPROMS, Matlab, Aspen, Python, DynoChem or similar in API or DP development or in Biopharmaceutics modeling.
• Advanced scientific network within academia and industry.
• An ability to work as part of a team, engaging other scientists with complementary skill sets in the field of Biopharmaceutics
• A change agent mentality, proposing novel approach to challenging scientific questions

Preferred Qualifications:

• Trained as Process Engineer prior to PhD
• A good knowledge in organic chemistry
• Experience in Advanced Process Control and automation
• Some knowledge in Multivariate Analysis, chemometrics and statistics
• Experience in the development and scale-up of continuous processes

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.