Scientist I - Formulation Development
Astellas Pharma
Summary
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.
Job description
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
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 401(k) Match
- Company Paid Life Insurance
- Annual Corporate Bonus
- Quarterly Sales Incentive
- Long Term Incentive Plan
- Company Paid Fleet Vehicle
- Referral Bonus Program
Company overview
Astellas Pharma Inc. is a leading Japanese multinational pharmaceutical company headquartered in Tokyo, Japan. Founded in April 2005 through the merger of Yamanouchi Pharmaceutical (established 1923) and Fujisawa Pharmaceutical (established 1894), Astellas has grown into a global life sciences company with operations in more than 70 countries worldwide. The company employs approximately 14,500 people globally and generates annual revenues exceeding $12 billion. Astellas is committed to turning innovative science into value for patients through transformative therapies in key therapeutic areas including oncology, ophthalmology, urology, immunology, and women's health. The company's notable products include Xtandi for prostate cancer, Padcev for bladder cancer, Xospata for acute myeloid leukemia, Veozah for menopausal symptoms, and Izervay for geographic atrophy. With a strong focus on research and development, Astellas invests approximately 17% of its sales revenue into pioneering new healthcare solutions for diseases with high unmet medical needs. The company operates multiple research centers in Japan, the United States, and Europe, and has established strategic partnerships and acquisitions to expand its pipeline and capabilities in areas such as gene therapy and immuno-oncology.