Formulation Scientist - Aquestive Therapeutics
Warren, NJ 07059
About the Job
Job Summary:
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 orally dissolving thin films for transmucosal delivery or lotions, ointments, and creams for topical delivery.
Responsibilities:
- Conducts laboratory activities and formulation work in support of product development, product characterization, and process optimization initiatives.
- Optimizes formulations to achieve desired product properties.
- Prepares laboratory prototype samples for pre-clinical, in-vitro, and stability evaluations.
- Prepares small scale/pilot batches for production trial runs in a GMP environment prior to large scale manufacture.
- Applies Quality by Design (QbD) methodologies to ensure the robust development of drug products.
- Executes, and analyzes, and interprets data derived from Design of Experiments (DoE) trials in support of formulation design initiatives.
- Ensures that developmental products meet all the identified target quality attributes of the drug product.
- Performs various activities to maintain an efficient, effective, and safe laboratory environment.
- Assists in writing technical communications for both technical and non-technical audiences. These may include reports and procedures for experimental studies, formulation development reports, batch records, risk assessments, and support for regulatory interactions.
- Continually reviews current relevant literature and activities within the field(s) of interest.
- Other duties as assigned.
Qualifications:
- MS (PhD desired) in science (preferably chemistry) with 0-5 years’ experience in pharmaceutical development.
- Diverse pharmaceutical product design and development experience desire
- Basic knowledge regarding applied polymer chemistry and drug delivery preferred.
- Basic understanding of formulation development principles, DoE/QbD, and FDA/ICH guidelines is preferred.
- Synthetic organic chemistry, medicinal chemistry, or pharmaceutics experience is a plus.
- Working knowledge of laboratory practices and techniques.
- Must be willing to perform hands-on work required in the laboratory.
- Strong writing skills for the preparation of reports and presentations.
- Proficiency in standard office software (e.g., MS Word, Excel, PowerPoint).
- Must be detail oriented, organized, and able to maintain detailed records
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.