Senior Scientist, Vaccines Formulation Development

Proclinical is currently recruiting for a Senior Scientist of Vaccines Formulation Development with a leading biotechnology company located in Gaithersburg, MD. As the Senior Scientist, you will be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development from initial candidate identification through commercialization.

Job Responsibilities:

• Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
• Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
• Assay method development and validation including: AUC, CD, Fluorescence spectroscopy, DSC, ITC, UV/Vis spectroscopy, FTIR, SLS and HPLC.
• Develop SOP documentation for new processes and equipment.
• Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers.
• Review all formulation developed methods and protocols.
• Support in activities and documentation for technology transfer to CMC facilities.
• Lead scientific discussion and investigations for all drug substances and drug products being developed.
• Project management of research associates in support of the larger drug development project.
• Support Regulatory Affairs in IND and BLA submission.

Skills and Requirements:

• PhD in relevant field or a minimum of 10 years relevant experience with a Master's degree required.
• Experience in vaccines 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 leadership and grant management.
• Significant experience in designing and initiating research projects.
• Knowledge of aseptic manufacturing and fill/finish process related to liquid and solid formulation products.
• Knowledge and experience in GLP and GMP requirements.
• Demonstrated expertise with bio/analytical and physicochemical characterizations of proteins, including 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 Max Robinson at (+1) 617-903-7746 or m.robinson@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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