Formulation Development Scientist I – Gene Therapy

Astellas Pharma; South San Francisco (CA); On-site; USD 91,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) match and company contribution

Annual Corporate Bonus

Long Term Incentive Plan

Company-paid fleet vehicle

Job summary

Astellas Pharma Inc. is seeking a Scientist I in Formulation Development to design and evaluate formulations for rAAV drug products under development, supporting AGT's pipeline. This role requires collaboration with multiple teams to ensure stability and regulatory readiness.

The candidate will work on stability studies, device compatibility, and preparation of regulatory submissions, with emphasis on quality and scientific rigor. Based in US or Japan with on-site work expectations.

Qualifications

• Advanced degree in biology or engineering.
• 5+ years of relevant biopharmaceutical experience.
• Business-level proficiency in English.

Responsibilities

• Evaluate and understand properties of new rAAV and propose formulations with stability for clinical use.
• Conduct in-use stability and device compatibility studies for administration at clinical sites.
• Author IND and briefing documents; prepare responses to agency information requests.
• Join cross-functional discussions to align and enable efficient drug development work.
• Evaluate analytical tools and methods to develop rAAV formulation.

Skills

Biology

Engineering

English proficiency

Drug formulation

Education

Advanced degree in biology or engineering

Tools

Chromatography

Electrophoresis

Job description

Astellas Pharma Inc. is seeking a Scientist I in Formulation Development to design and evaluate formulations for rAAV drug products under development, supporting AGT's pipeline. This role requires collaboration with multiple teams to ensure stability and regulatory readiness.

The candidate will work on stability studies, device compatibility, and preparation of regulatory submissions, with emphasis on quality and scientific rigor. Based in US or Japan with on-site work expectations.