Astellas Pharma · 4 days ago
Scientist II (Formulation Development)
South San Francisco, CA
Full-time
Onsite
Mid, Senior Level
$104K/yr - $163K/yr
8+ years expAstellas Pharma is a pharmaceutical company dedicated to developing innovative therapies for patients. The Scientist II role focuses on designing, evaluating, and developing formulations and manufacturing processes for rAAV drug products, supporting the company's growing pipeline.
BiotechnologyHealth CareMedical
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 healthcare agencies.; prepare responses to Information Requests from agencies
For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data
Evaluate new medical devices or container-closures for local injection products
Lead 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
Participate the program meetings to achieve key milestones in a timely manner
Regularly present data and conclusions in sub-team meetings
Occasionally presents technology summaries to management and program teams
Qualification
Required
Master's degree (MS) in Biology or Engineering with 8+ years of relevant experience in the biopharmaceutical industry
Experience in formulation development for biopharmaceutical products
Experience in authoring IND, BLA or other related regulatory filings, and responding to agency feedback/inquiries
Proven and successful history of taking direction and working independently in a fast-paced environment
Positive, professional attitude with a passion for science
Outstanding collaboration and problem-solving skills; team player with excellent communication and organizational abilities
Preferred
Experience with process development and technology transfer to GMP facilities for drug product manufacturing process
Experience with preparation activities for PPQ of drug product manufacturing processes
Experience in the development of packaging process and transportation validation for drug products
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
Experience with handling rAAV gene therapy vectors or other viral particles
Bilingual: ability to communicate in English and Japanese
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 fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase