Principal Scientist Formulation & Innovation

Role Summary

Principal Scientist, Formulation & Innovation to lead hands-on development of robust, scalable formulations enabling delivery via oral mucosal and topical routes. Drive formulation development for Rx and Direct to Consumer NPP, evaluate new excipients and technologies, and contribute to rapid advancement of Aquestive’s product pipeline and platform capabilities.

Responsibilities

• Formulation Development & Execution
  • Design, optimize, and execute formulation strategies to support product development from prototype through clinical and commercial scale for Rx and DTC NPPs.
  • Develop formulations that enable controlled drug delivery through oral mucosa (sublingual, buccal) and topical routes, supporting the PharmFilm and Adrenaverse platform applications for Rx and DTC NPPs
  • Prepare and characterize prototypes for in vitro, ex vivo, and in vivo evaluation.
• Innovation & Technology Integration
  • Assess and implement novel excipients, permeation enhancers, and delivery technologies that will rapidly advance Aquestive‚Äôs Rx and DTC new product pipeline and technology/development platforms.
  • Serve as a subject matter expert (SME) in topical formulation, enteral, sublingual, buccal transdermal and thin film technologies, collaborating cross-functionally to identify and exploit new opportunities to fully enable product ideas in the Rx and DTC NPPs.
  • Generate constant flow of new ideas and lead ‚Äúskunk works‚Äù projects from ideation to assessment at PIC.
• Scale-Up & Process Support
  • Develop robust formulation processes suitable for scale-up to clinical and commercial manufacturing.
  • Author and execute GMP manufacturing batch records for Phase I clinical supplies.
  • Provide technical support for technology transfer, CMC documentation, and manufacturing readiness.
• Scientific Communication & Reporting
  • Write technical reports, protocols, and regulatory support documents.
  • Prepare and present research data internally and externally, including publications and scientific conferences.
  • Prepare presentations for internal communications with data analysis and insights for R&D and other functions including Medical, Clinical, Regulatory, Quality and Operations.
• Mentorship & Lab Management
  • Mentor junior scientists in experimental design, formulation techniques, and data analysis.
  • Ensure rigorous scientific practices, data integrity, and laboratory compliance with internal standards.
  • Maintains DB current in applicable literature findings in applicable research spaces.

Qualifications

• Education: Ph.D. (preferred) or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• Experience: 6‚Äì10 years of experience in pharmaceutical formulation development, with significant exposure to alternate delivery systems (oral thin film, transmucosal, or topical preferred).
• Experience: Product ideation and selection along with keen understanding of best practices in stage gated product development processes (PDP).

Skills

• Strong background in formulation design, optimization, and characterization.
• Experience with thin film, coating, and related manufacturing processes.
• Hands-on expertise with experimental design, data analysis, and statistical tools (e.g., JMP).
• Excellent technical writing and scientific communication abilities.
• Proven ability to work cross-functionally within a fast-paced, innovative environment.
• Detail-oriented, organized, and driven to deliver high-quality results.
• Ability to manage a team for results in a staff role including daily and weekly assessment of performance via select set of KPIs and metrics.
• Artificial Intelligence (AI) powered technology experience desirable.