Principal Scientist Formulation

Job Title: Principal Scientist Formulation

Location: Cambridge, MA

About the Job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

This position plays a key role in the development of oral solid dosage formulations for small molecule drug products. The successful candidate will be responsible for designing, developing, and optimizing preclinical formulations (conventional and enabling) and clinical solid oral dosage forms (tablet and capsule) from early-stage development through scale-up and technology transfer to GMP manufacturing. Working collaboratively with cross-functional CMC teams, you will apply hands-on expertise with manufacturing equipment and scientific principles to advance drug candidates into clinical development.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
 

Main Responsibilities:

Formulation Development

• Design and develop oral solid dosage formulations (tablets, capsules, granules) to support preclinical and clinical programs.

• Execute formulation studies including excipient compatibility, prototype development, and formulation optimization.

• Develop both conventional and enabling formulations (e.g., amorphous dispersions) as needed to address bioavailability challenges.

Process Optimization

• Lead formulation and process development activities, including granulation (wet and dry), blending, compression/tableting, and encapsulation.

• Apply DoE methodologies to optimize formulation and process parameters.

Scale-Up & Tech Transfer

• Scale up formulations from laboratory to pilot and production scale.

• Troubleshoot manufacturing issues and implement solutions.

• Execute technology transfers of developed formulations from R&D to GMP manufacturing sites.

Cross-Functional Collaboration

• Collaborate within the CMC team as a contributing member, supporting defined deliverables and milestones.

• Work with Analytical, Biopharm, Toxicology, Quantitative Pharmacolog, DMPK, Quality, and Regulatory colleagues to ensure alignment on development strategies.

• Partner with Research teams to evaluate molecular attributes relevant to drug delivery and formulation design.

Documentation & Compliance

• Author and review technical reports, batch records, and regulatory documents.

• Ensure all documentation is accurate, complete, and compliant with GMP requirements.

• Maintain awareness of current scientific literature and apply new concepts as appropriate.

About You

KNOWLEDGE AND SKILLS

• Hands-on experience with preclinical formulation development especially amorphous solid dispersion, lipid based and nanosuspension formulations.

• Strong knowledge of CMC pharmaceutical development, including hands-on operation of manufacturing equipment and laboratory instruments (compression, wet/dry granulation, capsule filling, coating, etc.).

• Experience with process development, optimization, and scale-up activities of solid oral dosage forms for clinical development phases.

• Familiarity with technology transfer processes and working with CROs/CMOs.

• Working knowledge of scientific and statistical approaches including DoE and data analysis.

Basic Qualifications:

• PhD in a scientific field with 5+ years of relevant experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 8 years experience.

• A degree in Pharmaceutics is preferred.

• Excellent laboratory skills and the desire to conduct lab work.

• Excellent laboratory skills and the desire to conduct lab work.

• Demonstrated hands-on experience with oral solid dosage manufacturing equipment, including:

• Amorphous solid dispersion, nanosuspension and lipid based formulations

• Tablet presses (rotary and single-station compression)

• Granulation equipment (high-shear, fluid bed, roller compaction)

• Capsule filling machines

• Coating equipment

• Compaction Simulators

• Strong understanding of powder characterization techniques and their application to formulation development.

• Strong problem-solving skills and scientific curiosity.

• Effective oral and written communication skills.

• Ability to work collaboratively in a team environment.

• Good organizational skills with ability to manage multiple projects.

• Experience with outsourcing and overseeing work done by CRO/CMOs.

• Experience working with cross-functional teams.

• Excellent communication skills.

• Track record of scientific publications.

Why Choose Us? 

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or a lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave. 

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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Pursue progress, discover extraordinary

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!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$122,250.00 - $176,583.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.