Assay Development, Biotech and Pharmaceutical, Business Ethics, Conferences, Drug Products, GMP (Good Manufacturing Practices), Gene Therapy, GxP, JavaOS (Java Operating System), Manufacturing, Manufacturing/Industrial Processes, Medical Products, Operations Processes, Process Development, Product Development, Product Support, Product Testing, Quality Assurance Methodology, Regulations, Reporting Skills, Research & Development (R&D), Risk Analysis, Scientific Publications, Standard Operating Procedures (SOP), Status Reports, Team Player, Technical Publications, Test Plan/Schedule, Testing, Time Management, Writing Skills
Scientist II
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.
Purpose
The Scientist will take a lead in developing and transferring assays for the GMP release of drug substances and drug products as well as product characterization activities. The Scientist will work closely with research group to develop first-in-class drugs and will be a representative of AD in supporting product development, understanding of product behaviour throughout the manufacturing process, project timeline, and requirement for product release. The Scientist will work collaboratively with colleagues across different departments of AGT and will be responsible for drafting JOS, CQA-RA, and protocols and reports for comparability study. This role will be at our South San Francisco R&D facility.
Essential Job Responsibilities
- Develop and transfer assays for the GMP release of gene therapy products; write assay development report and SOP.
- Work collaboratively cross teams and author protocol and report for comparability study report of justification of spec (JOS), setting, and report of critical quality attributes risk assessment (CQA-RA).
- Collaborate with research group to develop first-in-class drugs.
- Lead product characterization activities for gene therapy products.
- Troubleshoot problems that occur during product development, release testing, process development, scale-up, or in Manufacturing.
- Evaluate product testing results and support product formulation and processes.
- Report project status, development plans, timelines to supervisor and technical teams.
- Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations.
- Attend training sessions and conferences in order to maintain and increase skills and knowledge of GXPs, safety awareness, and scientific knowledge.
- Follow relevant Operating Procedures.
A
Astellas Pharma Inc
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.
2,500 to 4,999 employees
Biotechnology/Pharmaceuticals
https://www.astellas.com/us/