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 .

REQUIRED QUALIFICATIONS

Advanced degree 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, BLAor 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
Business-level proficiency in English

PREFERRED QUALIFICATIONS

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.
Salary Range : $103,600 - $148,000 (NOTE: Final salary could be more or less, based on experience)

PURPOSE AND SCOPE:

The primary purposes of the Scientist II, 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 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