• In depth understanding of bio-chemical and physical properties of therapeutic biologicals including but not limited to proteins, virus-like particle, and bacteria. Have basic knowledge of protein quantification and characterization methods.
• Develop methods to characterize and understand the pharmaceutical properties of drug substances and formulations
• Develop and perform the screening and selection of formulation excipients, adjuvants for formulation development for biological drug candidates
• Design and perform experiments to determine the stability in prototype formulations, to achieve formulations with acceptable shelf-life
• Understanding of basic cycles of Lyophilization of biologics drug substances in industry and the critical parameters to control the yield and stability. Experience of developing lyophilization cycle is a plus.
• Experience of Milling, blending, coating, packaging operation for capsule or tablet product is a plus
• Scale up experience for fill finish a plus
• Mammalian cell culture, bacterial culture, and cell-based assay experience is a plus
• Write reports and summarize the data for presentations and regulatory submissions
• Strong organizational and technical problem-solving abilities
• Experience supporting pharmaceutical product development and transfers to clinical manufacturing is a plus
• Ability of effectively prioritizing tasks and managing multiple projects
• Act as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner
• 0 - 3 years or more of experience in the pharmaceutical formulation or drug product development field
• PhD degree in chemistry, biochemistry, pharmaceutical sciences, or a related field.
• Excellent written and verbal communication skills required.