(Senior) Research Associate, Biologics Formulation

Proclinical is currently recruiting for a (Senior) Research Associate of Biologics Formulation with a global biotechnology company located in Gaithersburg, MD. As the Research Associate, you will support the Formulation Development department participate in the development of both liquid and lyophilized biologic formulations to support product development from initial candidate screening through commercialization.

Job Responsibilities:

• Develop, characterize, and evaluate formulation for preclinical and early clinical studies in solid and liquid product presentations.
• Perform rapid, comprehensive characterization of candidate biologic drug products to determine the physicochemical properties of the drug product and evaluate them for further drug development programs including: PK AUC, circular dichroism, Fluorescence spectroscopy, Differential scanning calorimetry, ITC, UV/Vis spectroscopy, FTIR, static light scattering and HPLC.
• Assist in the development and scale-up of biologics drug product processes from bench top to pilot scale and technology transfers.
• Provide support to formulate small and large scale lots of liquid, frozen or lyophilized drug substance/product samples.
• Assist in development of formulation studies and design protocols.
• Project management of other research associates in support of the larger drug development project. Write technical reports and applicable SOPs.
• Responsible for preparing data summary presentations, compiling data and authorizing technical reports. Percentage of time

Skills & Requirements:

• Requires a minimum of 5 to 8 year of relevant experience with a Bachelor degree or a minimum of 3 to 5 years with a Master degree.
• Experience in formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
• Direct experience and expertise in protein drug substance synthesis, characterization, evaluations and formulation development.
• Direct experience and expertise in biologics, and/or vaccine drug product development
• Direct experience and expertise in lyophilization cycle design, operations, and evaluation for freeze-drying drug products.
• Direct experience in project management.
• Experience in designing and initiating research projects.
• Working knowledge of aseptic manufacturing and fill/finish process related to liquid and solid formulation products.
• Working knowledge of container closure for liquid and solid formulation products.
• Hands on experience with bio/analytical and physicochemical characterizations of proteins. Prior research experience in the areas of protein synthesis, structure, stability, aggregation, and solubility is highly desirable.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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