Associate Director Crystallization

TieTalent; Cambridge; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading global healthcare company is seeking an Associate Director of Crystallization in Cambridge. The role involves leading a team in selecting and developing crystallization processes for active pharmaceutical ingredients, requiring a strong background in crystallization engineering and leadership skills. The ideal candidate will have a PhD or Master's degree with significant experience in the field, and will collaborate closely with cross-functional teams to drive innovation in pharmaceutical development.

Benefits

Comprehensive rewards package

Health and wellbeing benefits

At least 14 weeks of gender-neutral parental leave

Qualifications

• Minimum 6 years of experience for PhD or 10 years for Master's.
• Proven track record in developing and leading crystallization processes.
• Familiarity with PAT and common analytical techniques.

Responsibilities

• Lead a team to select API physical forms for new NCEs.
• Develop processes for producing API with required quality attributes.
• Mentor others and facilitate close interactions with project teams.

Skills

Leadership

Crystallization Engineering

Solid-State Chemistry

Team Collaboration

Analytical Techniques

Education

PhD in Chemical Engineering or Solid State Chemistry

Master’s degree with at least 10 years of experience

Tools

gPROMS

DynoChem

Matlab

Python

Job description

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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 a 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 modeling will be key drivers to transform Pharma process development.

Key Responsibilities

1. 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 manufacturability, physical properties, scalability, and stability.
2. 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, including techniques such as XRD, DSC, PSD, SEM, optical microscopy, LC, GC, KF.
3. The candidate will be expected to dedicate part of their time to work on continuous improvement with internal resources 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 processes 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.
4. Lead Tech Transfer of crystallization to the Pilot Plant and Manufacturing, including support for technical and HSE risk assessments, review of Master Batch Records, and campaign coverage for key batches.
5. 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.
6. 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, Solid State Chemistry, or related field with a minimum of 6 years of experience, or Master’s degree with at least 10 years of experience in academia or industry.
• Proven track record in developing and leading crystallization processes.
• Ability to work as part of a team, engaging with scientists with complementary skill sets in pharmaceutical development.
• A change agent mentality, proposing novel approaches to scientific questions and exploring new modeling approaches.
• Ability to design and deliver lab experimental plans for crystallization process development, including process and analytical experiments.
• Familiarity with PAT and common offline analytical techniques such as HPLC, GC, and NMR.

Preferred Qualifications

• Modeling experience using gPROMS, DynoChem, Matlab, Python, or similar languages.
• Knowledge of Multivariate Analysis, chemometrics, and statistics.
• Experience in developing and scaling up continuous processes.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and advance your career, whether through promotion or lateral moves, locally or internationally.
• Enjoy a comprehensive rewards package that recognizes your contributions and amplifies your impact.
• Take good care of yourself and your family with health and wellbeing benefits, including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, marital status, sex, gender identity, disability, veteran status, or other protected characteristics.