Senior Associate Scientist – Biologics Formulation

Senior Associate Scientist – Biologics Formulation

Requirements

• B.S. (with 3-6 years experience) or M.S (with 0-5 years experience) in Chemistry, Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Biomedical Engineering or related field with experience in formulation development or manufacturing of drug products for biologics.

Responsibilities

• Design, conduct and interpret data from pre-formulation screening and formulation development experiments.
• Plan work based on specific objectives.
• Prioritize tasks; keep management/team informed of progress and adjust work accordingly.
• Display an understanding of project goals.
• Design and conduct studies to characterize molecular and biophysical properties of peptides, proteins, monoclonal antibodies and other large molecules.
• Design and development of parenteral biologic formulations (solutions, lyophilized products, and other dosage forms).
• Manufacture and supply formulations/drug product to non-pivotal and pivotal clinical studies.
• Collaborate with and support formulation team and project teams for successful completion of formulation development, stability studies and manufacture of clinical supplies.
• Record experiments and data appropriately and author technical reports.
• Keep abreast of relevant new technologies & regulatory expectations/requirements.
• Ensure work activities are aligned with relevant Quality, Regulatory and EHS requirements.

Preferred Qualifications

• Basic understanding of parenteral formulation development for biologics.
• Knowledge or working experience in protein chemistry, degradation pathways, and general approaches for stabilization.
• Ability to independently contribute from the bench.
• Ability to design and execute formulation optimization and data analysis/interpretation.
• Good oral and written communication skills.
• Must be highly motivated. Able to take directions and work simultaneously on multiple projects is essential.