- Develop and transfer assays for the GMP release of gene therapy products.
- Lead product characterization activities for gene therapy products.
- Troubleshoot problems that occur during 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.
- Write tech transfer and development reports.
- Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
- Attend training sessions and conferences in order to maintain and increase skills and knowledge of cGMP's, safety awareness and scientific knowledge.
- Follow relevant Operating Procedures.
- This position reports to the Lead, Analytical Development.
- This position is an individual contributor role.
- This position requires onsite work.
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Scientist II, Analytical Development - California, United States - Astellas
Description
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 .
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website:
The Role:
The Scientist II 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. In addition, the Scientist II will be a point person for the understanding of product behavior throughout the manufacturing process. This will involve collaboration with colleagues across different departments of AGT. This role will be at our South San Francisco R&D facility.
Responsibilities:
Organizational Context:
