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Principal Scientist, Formulation Development (Small Molecules)

Boston, MA

Salary Band: $160,000-$220,000

Location: Downtown Boston, MA (In-Office Minimum 3 Days/week)

Position Summary

The Principal Scientist, Formulation Development, will lead the design and optimization of drug product formulations to support research, early clinical and late stage development. This role involves significant hands-on experimental work to create oral dosage forms and innovative delivery systems to support pre-clinical and clinical development.  The role has direct responsibility for technical execution, and cross-functional collaboration to support the company’s advancement of novel programs.

Key Responsibilities

  • Formulation Development– Develop and implement formulation strategies for small molecules, ensuring alignment with Quality Target Product Profile (QTPP) and CMC objectives
  • Design and Optimize Formulations– Utilize advanced in-house and external technologies (e.g., solid dispersions, co-crystals) to enhance solubility, stability, and manufacturability
  • Scale-Up and Tech Transfer– Oversee scale-up activities, CTC profiling, dissolution studies and packaging configurations.  Directly manage technology transfer to external partners
  • Stability and Performance Testing– Design and interpret stability studies using ICH and ASAP techniques.  Implementation of robust in-process controls and product performance
  • Cross-Functional Collaboration– Partner with Analytical Development, Chemical Development, Regulatory Affairs, and Quality to deliver integrated CMC solutions
  • Documentation and Compliance– Prepare technical reports, protocols, internal updates and regulatory submissions in compliance with internal policies and global regulations
  • Innovation and Leadership– Champion opportunities to introduce enabling technologies for process improvements and develop best practices

Qualifications and Experience

  • PhD in Pharmaceutical Sciences, or a related field with 8+ years of experience in formulation development or M.S. with 12+ years.
  • Proven track record in developing oral solid dosage forms and supporting IND/NDA submissions
  • Expertise in pre-formulation, manufacture and advanced delivery technologies
  • Knowledge and experience in developing amorphous dispersions is an advantage
  • Strong knowledge of regulatory guidelines (ICH, FDA) and GMP principles
  • Excellent leadership, communication, and technical writing

The anticipated annual salary range for this position is $160,000-$220,000 annually. The actual salary offered will be based on a number of factors, including but not limited to the qualifications of the applicant, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location in which the applicant lives and/or from which they will be performing the job.

 

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