Athenex is developing a new class of innovative T cell therapies that can harness the immune system to recognize and destroy solid tumors more effectively. Through the TCR-T technology platform, Athenex has generated engineered T-cells with higher binding affinity, specificity, expression level and persistence.
A successful candidate will develop and implement a viral vector manufacturing strategy to support the company’s cell and gene therapy programs. He or she will also collaborate with internal and external partners to ensure the development and execution of viral vector analytical methods that meet health authority guidelines and global qualification standards.
· Apply manufacturing concepts, tools and practices while driving to redefine how they are applied in this novel and growing field.
· Develop viral vector processes, preferably lentiviral, for multiple projects.
· Ensure the timely delivery of high-quality products and solutions.
· Support the team in defining and executing the technical strategies. Specifically, design and deliver state of the art viral production processes and identify and implement advanced technologies driving competitive advantages to all aspects of cell and gene therapy manufacturing.
· Support the establishment of good technology transfer practices to drive the efficient transfer of processes to GMP plants.
· Drive the execution of initiatives, technology and activities to strengthen cell and gene therapy technical development through innovation, quality and productivity.
· Identify risks and propel continuous improvements in development and manufacturing processes through technological innovation and alignment with regulatory and commercial vector manufacturing requirements.
· Direct functional compliance with regulatory requirements and quality systems in a GMP environment.
· Review and approve CMC documentation for regulatory filings as well as attend pertinent regulatory meetings as the functional owner.
· Maintain detailed knowledge of global CMC regulatory requirements and the changing environment relevant for cell and gene therapies.
· Work in partnership with quality, process development, logistics and other functions to ensure group activities are aligned with corporate objectives.
· A B.S. in the pertinent life sciences or engineering, with 5+ year's relevant experience. Advanced degrees desirable.
· Experience managing a broad organization as well as external manufacturing providers, partners and or academic collaborations is required.
· Several years of experience in regulatory CMC and/or viral vector gene therapy technical product development (process, formulation, analytical, quality).
· Knowledge and understanding of US and international regulations and ICH guidelines related to CMC cell and gene therapy development.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.