Principal Scientist Formulation & Innovation

Job Summary:

Aquestive Therapeutics is a growth-stage pharmaceutical company redefining patient care through transformative patient centric drug delivery technologies and new therapies for patients. Our proprietary PharmFilm® and Adrenaverse™ platforms enable needle-free therapeutics via oral, transdermal, and topical routes. We have brought four prescription products to market and are advancing key pipeline programs, including Anaphylm™ (epinephrine sublingual film) and AQST-108 (topical epinephrine gel).

We are seeking a Principal Scientist, Formulation & Innovation to play a hands-on leadership role in developing robust, scalable formulations that enable the delivery and absorption of drugs via oral mucosal and topical routes. Reporting to senior R&D leadership, this individual will drive key formulation development activities for the Rx and Direct to Consumer (DTC) New Product Pipeline (NPP), evaluate new excipients and technologies to fully enable all programs in the NPP, and contribute to rapidly creating and advancing Aquestive’s new 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’s 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 “skunk works” 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: 6–10 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)

Technical Expertise:

• 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).

Other Skills:

• 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

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $120,000 to $160,000 USD