Senior Formulation Scientist

Aquestive Therapeutics•Warren Township, NJ

About The Position

A hands-on scientific position evaluating, designing, and executing robust scaleable formulation development plans. The position will focus on enabling delivery and absorption of drugs and complex molecules via oral, transdermal, and topical routes. Also, the position will function as a key member of the team responsible for evaluation and execution of study plans to drive the development of new or alternative technologies and innovations.

Requirements

MS or PhD (preferred) degree in a relevant scientific discipline with 5-10 years' experience in pharmaceutical development.
Experience in alternate delivery of drugs (oral, transmucosal, topical) preferred
Strong background in formulation design, optimization, and characterization
Hands-on expertise with experimental design, data analysis, and statistical tools.
Excellent technical writing skills for preparing reports and presentations.
Good understanding of formulation development principles, DoE/QbD and FDA/CMC/ICH guidelines are required
Regulatory document authoring experience is required
Must have an ability to work on multidisciplinary teams to drive innovation that leads to commercially viable products/technologies.
Proficiency in standard office software (MS Word, Excel, PowerPoint) and statistical analysis tools (i.e. JMP).
Must be detail oriented, organized, and suited to work in a dynamic fast-paced environment.

Responsibilities

Responsible for design, execution, and analysis of formulation strategies in support of product development, product characterization and process optimization relating to Aquestive’s pharmaceutical business.
Designs and optimizes formulations to achieve drug product properties for controlled delivery of drugs (i.e. oral, transmucosal, and topical).
Designs, prepares, and characterizes laboratory prototype samples for in vitro, ex-vivo, and in vivo evaluation.
Evaluates and vets new and emerging technologies to drive innovative drug delivery.
Serves as an Aquestive SME for new product/technology opportunities, collaborating cross-functionally with internal and external stakeholders.
Responsible for developing robust formulations and processing conditions for the successful scale up to commercial equipment.
Authors and executes manufacturing batch records for GMP manufacture of Phase I clinical supplies.
Authors technical reports and procedures for experimental studies and in support of regulatory activities. Provides technical support for technology transfer, CMC documentation, and manufacturing readiness.
Mentors junior scientists in formulation techniques, experimental design, and data analysis.
Maintains rigorous scientific practices, data integrity, and laboratory compliance within internal standards.
Performs other duties as deemed necessary to support laboratory operations.