职责描述: • Provide strategy, leadership and direction of internal process design, development, and optimization, scale-up and tech transfer of high-quality AAV production to meet goals and timelines. • Provide strategic leadership and technical direction of external efforts including tech transfer and/or external process development, optimization, and process characterization to define activities in support of timely clinical supply, process validation and commercial manufacture through submission, filing and launch • Manage and drive the AAV vector team, process development team and scale-up team to support internal preclinical activities and GMP manufacturing. • Transfer technology to internal and/or external GMP manufacturing • Serve as a subject matter expert at AAV process development and production. • Manage, mentor, motivate, develop, and retain scientists to support assigned activities; conduct performance reviews and drive goal setting and development planning. • Accountable for the key preclinical and regulatory documents for IND application and patent application within agreed timelines and meeting all regulatory requirements. • Establish and maintain strong relationships with key opinion leaders relevant to drug candidates and therapeutic areas. • Contributes to the identification and evaluation of potential business development opportunities for supporting corporate portfolio and QLD incubator. • Support business development team to evaluation external opportunity. 任职要求: • BS or MS in life science disciplines such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 10 years relevant experience or PhD (preferred) in a life science disciplines such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5 years of relevant experience. • Demonstrated experience in developing commercially viable AAV processes and lead AAV drug development from conceptualization to clinical production and strategy for commercialization • Demonstrated success in managing a team of scientists and engineers with a proven track record of leadership, people management and effective interpersonal skills • Outstanding oral and written communication skills with the ability to interface effectively at all levels within the organization to include pertinent input On scientific, technical and compliance issues • Embrace agility and possess a "can-do" attitude with a focus On team success with the ability to build strong cross-functional relationships. 关于我们: QLD Biotherapeutics Inc, located in Boston, Massachusetts, has over 24,000 SF state-of-the-art labs and facilities. We have the internal R&D focusing On the research and development of the advanced gene and cell therapies. In addition, we provide the funding and lab space to incubate the startups with breakthrough technologies or innovative programs. We’re looking for a highly motivated leader with a strong background in AAV process development to help drive the advanced AAV gene therapy pipelines. The successful candidate will lead a group of scientists.and engineers responsible for the development of process, technology transfer and AAV viral production.
