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About the Role
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.
Responsibilities
- 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.
Requirements
- 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
Skills
- Formulation development
- Analytical development
- rAAV formulation
- Stability studies
- Delivery device compatibility
- Regulatory document authoring (IND, BLA)
- Health authority interactions
- Cross-functional collaboration
- Analytical tools and methods
- Chromatography
- Electrophoresis
- Process development
- Technology transfer
- GMP facilities
- Vendor management
Location
- Japan
- US
Work Type
- On-site
Experience Level
- 5+ years of relevant experience in the biopharmaceutical industry
Education Level
- Advanced degree in biology or engineering
Salary/Compensations
- $91,000 - $130,000
Benefits
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company-paid fleet vehicle for eligible positions
- Referral bonus program
About the Company
- 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