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Form of workI-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.
The candidate will lead the study design in the development of stable formulations for biologics to support clinical development and product commercialization
Work hands-on to develop analytical methods and routinely test biologic formulations (HPLC assays, CE-SDS, icIEF, LC/MS, particle characterization, and other biophysical assays etc.) to support biological formulation and combination drug product development
Perform DOE formulation buffer, pH and, excipient screening, forced degradation, and accelerated stress studies to identify and optimize drug substance and drug product clinical formulations
Design and manage various compatibility studies, guide selection of appropriate container closure systems, and provide input for injection device design
Draft SOPs for laboratory and assay procedures; Prepare concise, sound scientific presentations of study results to the management team; maintain study records, author scientific technical reports, and contribute to regulatory filings
Perform method and technology transfer from laboratory to I-Mab QC or external CRO/CDMO to facilitate GMP activities
Participate complex drug product investigations including manufacturing related deviations, OOS, and customer complaints
Provide subject matter expertise across functions and participate project meetings as needed.
Demonstrate scientific leadership with the ability to drive innovation; Maintain current knowledge of latest scientific and technical trends in the field.
Work both independently and across functional teams
PhD. in Analytical Chemistry/Pharmaceutical Sciences or related field with at least 1-2 years, MS with 3-5 years, and BS with 7+ years of relevant industrial experience in analytical method development, Formulation Development and characterization of proteins
hands-on experience and in-depth knowledge in instrumentation and analytical techniques of proteins (SEC, IEX, RP-HPLC, UV, CE, SDS, DSC, MFI, HIAC etc.) applied to biologics
Ability to lead, design, execute, interpret and troubleshoot experiments
Excellent oral, presentation, and written communication skills, ability to communicate effectively with cross functional team members, management, and CROs/CDMOs
The job is based on San Diego, CA
All your information will be kept confidential according to EEO guidelines.
