Company Description

I-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.

Job Description

•    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
 

Qualifications

•    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

Additional Information

All your information will be kept confidential according to EEO guidelines.