Category: Scientific & Clinical
Title: Formulation Development Associate II
Location: Rockville, MD
The Development Associate II position will be responsible for supporting drug product formulation development for a biologics molecule heading to commercialization stage. This is a hands-on position in the laboratory involving design and execution of experiments to support PPQ and BLA-enabling activities.
Responsibilities and Job Duties
- This position will be primarily lab-based involving preparation of protein formulations, initiating stability studies, analyzing samples utilizing analytical methodologies. Other responsibilities included drafting protocol and summarizing results and data for team presentation or reports.
- Conduct clinical in-use compatibility study to support dose administration.
- Performing physicochemical evaluation using HPLC (SEC, CEX, HIC and RP), capillary electrophoresis methods (CE-SDS and cIEF), biophysical methods (CD) and general properties evaluation for protein concentration, pH, osmolality, visual inspection and subvisible particulates method using light obscuration, resonant mass measurement and MFI techniques.
- Perform stability pulls for a Design of Experiments Stability Study and run all analytical assays for stability pulls
- Bachelors or Master in Pharmaceutical Sciences, Chemistry, Biochemistry or (Bio-)Chemical Engineering preferred. BS with 3-5 years or MS with 1-2 years of relevant experience in biopharmaceutical industry is required.
- Technical knowledge in biologics formulation development for liquid, frozen liquid and lyophilized drug product.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.