Key Responsibilities:
- Oversee the development of a successful viral vector process, including process characterization, the performance of upstream processes, and the transfer of technology to manufacturing sites;
- Oversee process development and scale-up activities while establishing scale-down models;
- Oversee process development and scale-up activities while establishing scale-down models;
- Encourage innovation to improve the productivity and quality of viral vectors;
- Significant strategic and technical contributions to teams working on cross-functional development projects;
- Control a portfolio of multiple projects in development;
- Author related regulatory filing documentation;
- Present findings and/or outcomes at national and international conferences to top management, external stakeholders, and business leaders;
- Create the Upstream department's budget and timetable.
Qualifications:
- A PhD with at least 6 years of relevant experience in biotechnology, cell biology, biochemistry, chemical engineering, or a related field, or a Bachelor's degree with at least 14 years of experience;
- A track record of meeting aggressive timelines and the flexibility to adjust to rapid changes in project objectives;
- It is necessary to have extensive knowledge of both the theory and practice of developing cell culture processes, as well as experience working in the biotech/pharmaceutical sector in a cell culture function;
- It is highly desirable to have a molecular understanding of viral vector production, particularly AAV biology;
- AAV manufacturing knowledge and strong cell culture competence;
- Being able to oversee several projects concurrently, playing a significant role in cross-functional project and innovation teams;
