Formulation Development Cmc Jobs in Edison, NJ (NOW HIRING)

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.

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: $115,000.00 to $125,000.00 USD