Formulation Research Associate - Meet
Gaithersburg, MD 20883
About the Job
Job Summary:
We are seeking a skilled Formulation Research Associate to support the development, characterization, and evaluation of formulations for preclinical and early clinical studies. This role involves working with both solid and liquid product presentations, performing physicochemical analyses, and assisting in process development. The successful candidate will work closely with cross-functional teams, assist in scale-up processes, and support formulation studies to further drug development efforts.
Key Responsibilities:
- Develop, characterize, and evaluate formulations for preclinical and early clinical studies, focusing on both solid and liquid product presentations.
- Perform comprehensive and rapid characterization of candidate drug products, analyzing physicochemical properties using techniques such as ELISA, SRID, AUC, CD, Fluorescence spectroscopy, DSC, ITC, UV/Vis spectroscopy, FTIR, SLS, and HPLC to evaluate drug products for further development.
- Assist in the development and scale-up of drug product processes from bench-top to pilot scale and support technology transfer activities.
- Provide support for the formulation of small and large-scale lots of liquid, frozen, or lyophilized drug substance/product samples.
- Assist in the development of formulation studies and the design of protocols for research and development projects.
- Oversee and manage other research associates supporting larger drug development projects.
- Write technical reports, standard operating procedures (SOPs), and data summary presentations. Compile data and contribute to the authoring of technical reports.
- Assist with additional tasks and responsibilities as needed within the formulation development team.
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Pharmaceutical Sciences, Chemistry, or Biochemistry).
- A minimum of 2 to 5 years of relevant experience in formulation product development, particularly in the pharmaceutical or biotechnology industry.
- Experience with Quality by Design (QbD) and Design of Experiment (DOE) methodologies.
- Hands-on experience with bio/analytical and physicochemical characterizations of proteins, including prior research in areas such as protein synthesis, structure, stability, aggregation, and solubility is highly desirable.
Source : Meet