Biologics and bioconjugate therapeutics (such as monoclonal antibody, bispecifics, antibody-drug conjugate) rapidly emerge as the most effective way in the treatment of autoimmune disease, cancer, diabetes and various rare diseases. 9 out of top 10 best-selling drugs by revenue in 2024 are biologics, compared to 0 out of 10 in 2003 and 3 out of 10 in 2012.
WuXi XDC is a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global ADC and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs.
Responsibilities:
Engineer in-vitro functional stable cell lines to support therapeutic antibody and bioconjugate product development using viral (e.g., lentivirus, AAV) and non-viral methods (e.g., CRISPR-Cas9).
Develop and optimize cell lines through high-throughput screening, isolation, and validation of target-expressing cell populations.
Lead and mentor junior scientists to advance cross-functional project goals and foster team collaboration.
Design and implement cell-based functional assays to assess therapeutic mechanism of action (MOA), potency, and critical quality attributes (CQAs) for in-process and final product release testing.
Ensure regulatory compliance by following instrument calibration, personnel training, and end-to-end documentation (drafting, review, archival).
Support biologics regulatory submissions (e.g., INDs, BLAs) at WuXi XDC, including direct engagement with global agencies (US FDA, China NMPA) as required.
Basic Qualifications:
PhD or MS in Biochemistry/Biotechnology, Cell Biology, Immunology, or related field.
0-5 years for PhD or 5-10 years for MS of industrial experience in cell line development
Strong technical innovation and trouble-shooting skills in cell biology, molecular biology and biochemical research.
In-depth knowledge of molecular biological techniques, cell signaling transduction, and / or immune regulation knowledge.
Excellent spoken and written communication skills in English is a must.
Experience with use of electronic lab notebook and regulatory filings is preferred.