Principal Scientist Formulation & Innovation

Role Summary

Principal Scientist, Formulation & Innovation at Aquestive Therapeutics. Lead hands-on formulation development for oral mucosal and topical delivery, driving the Rx and Direct to Consumer New Product Pipeline, evaluating new excipients and technologies, and advancing product platforms.

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 enabling controlled drug delivery through oral mucosa (sublingual, buccal) and topical routes for PharmFilm and Adrenaverse platforms.
• 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 to rapidly advance Rx and DTC programs.
• Serve as SME in topical formulation, enteral, sublingual, buccal, transdermal and thin film technologies; collaborate cross-functionally to enable product ideas.
• Generate new ideas and lead skunk works projects from ideation to assessment.
• Scale-Up & Process Support
• Develop robust formulation processes for scale-up to clinical and commercial manufacturing.
• Author and execute GMP manufacturing batch records for Phase I 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, including publications and conferences.
• Prepare presentations for internal communications with data analysis for R&D, 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 lab compliance; keep literature current.

Qualifications

• Education: Ph.D. preferred or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• Experience: 6–10 years in pharmaceutical formulation development with exposure to alternate delivery systems (oral thin film, transmucosal, or topical preferred).
• Experience: Product ideation and selection with understanding of stage-gated PDP processes.

Technical Expertise

• Strong background in formulation design, optimization, and characterization.
• Experience with thin film, coating, and related manufacturing processes.
• Hands-on experience with experimental design, data analysis, and statistical tools (e.g., JMP).

Other Skills

• Excellent technical writing and scientific communication abilities.
• Cross-functional collaboration in a fast-paced, innovative environment.
• Detail-oriented, organized, and results-driven.
• Ability to manage a team and assess performance with KPIs.
• AI-powered technology experience desirable.