Senior Formulation Scientist

Aquestive Therapeutics; New Brunswick (NJ); On-site; USD 115,000 - 125,000; Full time

Job summary

Aquestive Therapeutics is looking for a hands-on scientific professional to evaluate, design, and execute formulation development plans. The role involves creating strategies for drug absorption and delivery across various routes, including oral and topical. This position will collaborate with teams to drive technological innovations and ensure rigorous scientific practices. Candidates should possess a relevant MS or PhD with 5-10 years of experience in the pharmaceutical field and a strong foundation in formulation design and data analysis.

Qualifications

• 5-10 years' experience in pharmaceutical development.
• Experience in drug delivery methods such as oral and topical.
• Hands-on expertise with experimental design and statistical analysis.

Responsibilities

• Design and execute formulation strategies for product development.
• Evaluate and implement new technologies for innovative drug delivery.
• Mentor junior scientists on formulation techniques and data analysis.

Skills

Formulation design

Data analysis

Technical writing

Statistical tools

Multidisciplinary teamwork

Education

MS or PhD in relevant scientific discipline

Tools

MS Word

Excel

PowerPoint

JMP

Job description

Job Summary:

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.

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.

Qualifications:

• 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.

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.

Expected Base salary range: $115,000.00 to $125,000.00 USD

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.