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Astellas Pharma

Global pharma advancing oncology, gene therapy

Scientist 1: AAV Formulation Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeTsukuba, Ibaraki, Japan

About the Job

Requirements

  • An advanced degree in biology or engineering and at least 5 years of relevant experience in the biopharmaceutical industry are required.
  • Experience in formulation development for biopharmaceutical products is required.
  • Business-level proficiency in English is required.

Responsibilities

  • Evaluate and understand the properties of new recombinant adeno-associated virus (rAAV) products and propose formulations with sufficient storage stability and suitability for clinical use.
  • Conduct in-use stability and delivery-device compatibility studies to ensure drug-product quality during administration at clinical sites.
  • Author regulatory documents, including Investigational New Drug (IND) applications and briefing documents for health-authority meetings, and prepare responses to agency information requests.
  • Participate in cross-functional and cross-divisional technical discussions to align and enable efficient drug-development work.
  • Evaluate and understand analytical tools and methods to develop appropriate rAAV formulations.

Desired Qualifications

  • Experience authoring IND, Biologics License Application (BLA), or other related regulatory filings, and responding to agency feedback or inquiries.
  • Experience with process development and technology transfer to Good Manufacturing Practice (GMP) facilities for drug-product manufacturing processes.
  • Experience operating basic analytical tools, such as chromatography and electrophoresis.
  • Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies.

About the Company

Astellas Pharma

Global pharma advancing oncology, gene therapy

Astellas develops medicines for diseases with high unmet medical needs, focusing on oncology, urology, nephrology, and ophthalmology. It uses precision medicine and next-generation modalities such as targeted protein degradation, cell and gene therapies, and immuno-oncology to treat complex diseases. Its Focus Area Approach lets it rapidly reallocate resources to promising breakthroughs, and it collaborates openly through innovation hubs and venture investments. Its goal is to translate science into life-changing therapies and expand global patient access while pursuing ESG commitments and a net-zero supply chain.

Company size
10,001+
Company stage
IPO
Headquarters
Tokyo, Japan
Founded
1894

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