Location: Cambridge, MA

Work Model: Onsite w/ ad-hoc flexibility for 1 day/week remote

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

This position influences the early synthetic small molecule candidate selection from a physical- chemical, drug delivery and bioperformance perspective through close collaboration with partners on the Research project teams. The successful hire will be the subject matter expert to inform, educate, and influence the teams in prioritizing the candidate molecules with desirable drug delivery and performance properties. This will include the assessment of in silico, in vitro and in vivo data as well as the design of stage- appropriate formulations for preclinical studies. In addition, you will be responsible for advancing the molecule into the clinical phase through developing the appropriate formulation to enhance exposure and attain clinical efficacy in the clinical stages of development.

• 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
  

• Collaborate with Early Discovery and Research partnersto 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 risksusing 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-functionallyto obtain feedback and alignment on projects and potential modifications to current drug product (DP) manufacturing processes.
  
• Develop new platformsto support complex formulations and drug delivery strategies for new and novel therapeutic modalities.
  
• Partner with Clinical, Manufacturing, and Research teamsto ensure the developability and manufacturability of clinical and commercial formulations.
  
• Collaborate with Regulatory and program leadsto support submissions and approval of product applications.
  
• Review and provide feedback and technical/scientific supporton 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 researchand present significant findings through internal and external presentations or publications.
  

• 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.
  

• 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 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.