Job Information
Sanofi- Genzyme Senior Scientist Formulation in Cambridge, Massachusetts
Key Requirements We are looking for a candidate with a strong technical background and experience in oral drug product development for small molecule modality, and hands on experience with developing conventional and enabling formulations. In-depth knowledge in process development, optimization and control strategy for drug product manufacture ranging from laboratory scale (R&D) to pilot/production scale (GMP) Strong experience in technology transfer and working with CROs/CMOs for oral drug product development and GMP manufacture Strong background in applying and scientific and statistical approaches in DoE and data analysis/interpretation Work location This is an On-Site designated role with ad hoc flexibility in Cambridge Crossing MA Key Responsibilities Collaborate with Early Discovery and Research partners to evaluate molecular attributes relevant to drug delivery and influence team strategies. Collaborate within the CMC team as the Formulation Lead and actively contribute to defined deliverables and milestones, and proactively engage in team discussion on risk mitigation. Execute and oversee technology transfers, scale-up and clinical product manufacture Design and develop fit-for-purpose preclinical formulations (both traditional and enabling) to support robust candidate selection and progression. Assess and clearly communicate drug delivery and performance risks using in silico, in vitro, and in vivo data, along with sound scientific principles. Support ongoing process and pipeline development, including process transfers to internal and external manufacturing sites. Work cross-functionally to obtain feedback and alignment on projects and potential modifications to current drug product (DP) manufacturing processes. Develop new platforms to support complex formulations and drug delivery strategies for new and novel therapeutic modalities. Partner with Clinical, Manufacturing, and Research teams to ensure the developability and manufacturability of clinical and commercial formulations. Collaborate with Regulatory and program leads to support submissions and approval of product applications. Review and provide feedback and technical/scientific support on project deliverables (e.g., remediation initiatives, plan reports), ensuring all documentation and reports are accurate, complete, and suitable for development, characterization, and regulatory approval of products. Maintain awareness of and contribute to scientific literature, actively applying new concepts as appropriate. Conduct novel research and present significant findings through internal and external presentations or publications. About you Role Requirements PhD in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or related technical field. A minimum of 5 years of Industry or equivalent experience in drug delivery development Leadership experience with proven ability to effectively lead and participate in teams. Excellent oral and written communication skills; attention to detail. Expertise in developing enabling oral drug products including amorphous dispersion and lipid- based formulation. Expertise in manufacturing processes including granulation, tableting, coating and encapsulation Deep understanding of principles and analytical techniques necessary to characterize powder and granular properties Familiar with global health authority regulations, regulatory filings, validation/qualification requirements. Strong organizational skills and ability to multitask across projects and activities. Up to 10% travel is required at times. 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 lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognize