A member of the R&D team responsible for the design and development of drug products for the targeted delivery of active pharmaceutical ingredients, including thin films for transmucosal delivery.
• Conducts laboratory activities and formulation work in support of product development, product characterization and process
• Optimizes formulations to achieve desired product properties.
• Prepares laboratory prototype samples for preclinical, in-vitro and stability evaluations
• Prepares small scale/pilot batches for production trial runs in GMP environment prior to large scale manufacture.
• Implements Quality by Design to ensure robust development of drug products.
• Execute and Analyze Design of Experiments in support of formulation design
• Ensures product meets all identified quality attributes of the drug product.
• Performs various activities to ensure efficient and effective laboratory supplies, processes and housekeeping
• Assists in writing technical reports and procedures for experimental studies, formulation development reports, batch records,
risk assessments, and supports regulatory interactions
• Maintain current on relevant literature and activities within the field(s) of interest.
• Other duties as assigned
• MS (PhD desired) in science (preferably chemistry) with 0-5 years’ experience in pharmaceutical development.
• Basic knowledge of polymers and drug delivery
• Diverse product development experience desired
• Basic understanding of formulation development principles, DoE/QbD and FDA/ICH guidelines is preferred
• Synthetic Organic Chemistry or Medicinal Chemistry experience a plus
• Working knowledge of laboratory practices and techniques.
• Must be willing to perform hands-on work required in the laboratory.
• Good writing skills for preparing reports and presentations.
• Proficiency in standard office software (MS Word, Excel, PowerPoint).
• Must be detail oriented, organized and very particular about record keeping.
The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as 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.
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.