Scientist I - Formulation Development

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

Benefits offered by this job

Medical insurance

PTO and holidays

401(k) match

Bonus program

Long term incentive

Fleet vehicle

Job summary

Astellas Pharma Inc. is seeking a Scientist I in Formulation Development to design, evaluate, and develop formulations and manufacturing processes for rAAV drug products. The role supports AGT’s pipeline with stability-focused formulation work for clinical use.

The candidate will collaborate with cross-functional teams, study device compatibility, and contribute to regulatory documents while advancing early-stage formulation science in a dynamic, global biopharma setting.

Qualifications

• Advanced degree in biology or engineering with 5+ years of relevant biopharmaceutical experience.
• Experience in formulation development for biopharmaceutical products.
• Experience authoring IND/BLA or related regulatory filings preferred.

Responsibilities

• Evaluate and understand properties of new rAAV and propose formulations with stability for storage and clinical use.
• Conduct in-use stability and device compatibility studies for administration at clinical sites.
• Author regulatory documents such as IND briefing documents and 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

Formulation development

Biopharmaceutical experience

Education

Advanced degree (biology or engineering)

Job description

Job Description

Scientist I (Formulation Development)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

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 .

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.
• C onduct 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

Required Qualifications

• 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

Preferred Qualifications:

• 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
• This position is based in Japan or US and will require on-site work.

Salary Range : $91,000 - $130,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

• 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
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company-paid fleet vehicle for eligible positions

Our organization is committed to diversity, equal opportunity, and affirmative action. We are an equal opportunity employer. All applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other protected characteristic.