Principal Scientist Formulation Full-time

Principal Scientist Formulation

Location: Cambridge, MA

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. 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.