Process Development
BeiCell Therapeutics is a growing cell therapy company built upon its innovative chemically induced pluripotent stem cell (CiPSC) technology and universal allogeneic cell therapy platform. We are seeking a highly motivated Director/Sr Director to lead our process development team. This role involves providing strategic and scientific leadership in advancing cell therapy products into clinical trials. The ideal candidate will possess over 5 years relevant experience. This is a full-time position based at our corporate headquarters in Beijing.
Responsibilities
Establish and mentor the process development team, providing strategic, scientific and operational direction in the development of scalable bioprocesses for cell therapy products. Lead development, optimization, and technology transfer activities related to cell therapy product processes.
Provide subject matter expertise across the organization in the field of cell banking, culture, harvest, formulation, cryo-preservation and clinical trial material manufacturing
Lead the design and execution of experiments using QbD principles, Design of Experiments (DoE), and process characterization/modeling techniques to develop and understand iPSC processes.
Drive development and innovation of technology platforms.
Tech transfer and scale-up of iPSC processes into non-GMP and GMP manufacture facility and CDMOs. Oversee the progress of CDMO and ensure quality standards are met
Be a part of CMC leadership in charting the future direction and growth of the organization, hiring, resourcing, budget, investment etc.
Interface with key stakeholders such as Research, Manufacturing, Quality, Clinical Development, and Regulatory to develop and execute multiple programs clinical and commercialization strategies.
Support authoring and review regulatory submissions.
Qualifications
Master’s degree or higher in Cell Biology, Immunology, Biochemistry, Bioengineering or a related field, with over 5 years of experience in leading cell therapy process development. Comprehensive understanding of cell therapy product development.
Extensive hands-on experience in establishing cell banks, cell differentiation, cell culture processes, and aseptic formulation processes.
Experience in authoring regulatory submission for IND, IMPD and BLA is desired
Prior experience in immune cell culture technology and process development is highly desirable.
Strong leadership and teamwork skills, with the ability to communicate effectively across departments.
Excellent written and verbal communication skills in both English and Chinese, with proficiency in reading professional literature and documentation and writing.
Working Conditions & Physical Requirements
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Will require working with cells and cell lines of human and/or animal origin.
Will require working with hazardous materials.
Will require occasional evening and weekend work.
100% onsite work at headquarters in Beijing.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, and internal equity.
Beicell offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
