Assay 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. Beicell Therapeutics is looking for a highly-skilled Assay Development Scientist to develop analytical methods for iPSC cell therapy products. The ideal candidate will have at least 3 years relevant work experience in assay development. This is a full-time position located at our corporate headquarters in Beijing.
Responsibilities:
Develop, qualify, and transfer analytical methods for iPSC cell therapy products.
Support QC department in final product release and stability studies. Provide technical support for deviation investigations, test method optimization
Support process development teams for in-process testing and process understanding.
Partner with Research, QC and QA in establishing product characterization package and release specification.
Draft, revise, and review relevant technical documents, including but not limited to SOPs, analytical methods, qualification reports, development reports, method transfer plans, and transfer reports.
Accurately and promptly record scientific data, maintaining detailed experimental records in compliance with applicable cGMP, safety, and environmental requirements.
Validate, calibrate, and maintain laboratory instruments and equipment.
Qualifications:
Master’s degree or higher in Immunology, Oncology, Synthetic Biology, Cell Biology, or a related field, with at least 3 years of relevant work experience. Experience in pharmaceutical and biotechnology companies, especially in cell and gene therapy, is preferred.
Proficiency in QPCR, ELISA, and flow cytometry, and experience in data analysis software. Experience in cell line development is a plus.
Ability to analyze experimental data, summarize and report results, and provide feasible solutions to challenges encountered in projects. Responsible for writing technical reports.
Good English reading and writing skills, along with strong interpersonal communication abilities.
Preferred candidates will have experience with regulatory knowledge related to gene and cell therapy drugs, preparation of clinical trial submission materials, familiarity with cGMP requirements, and experience in method development within relevant fields.
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.
