Scientist I, Analytical Development (HPLC)
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 Scientist will be responsible for developing assays for the GMP release of drug substances and drug products and will lead in product characterization activities. In addition, the Scientist will be a point person for the understanding of product behaviour throughout the manufacturing process. This will involve collaboration with colleagues across different departments of AGT.
Responsibilities:
- 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 SOP, tech transfer and development reports.
- Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
- Attend training sessions and conferences to maintain and increase skills and knowledge of cGMP’s, safety awareness and scientific knowledge.
- Follow relevant Operating Procedures.