Scientist I - Formulation Development

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

The primary purposes of the Scientist I, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT’s pipeline.

• →Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
• →Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
• →Author regulatory documents such as IND and briefing documents for meetings with health authorities.; prepare responses to Information Requests from agencies.
• →Join the technical discussion cross-functional/divisional to align and enable efficient drug development work
• →Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately.

• Advanced degree in biology or engineering with 5+ years of relevant experience in the biopharmaceutical industry
• Experience in formulation development for biopharmaceutical products
• Positive, professional attitude with a passion for science
• Business-level proficiency in English

• Experience in authoring IND, BLA or other related regulatory filings, and responding to agency feedback/inquiries
• Experience with process development and technology transfer to GMP facilities for drug product manufacturing process
• Experience in operating basic analytical tools, such as chromatography and electrophoresis
• Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies

• This position is based in Japan or US and will require on-site work.