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(Associate) Scientist, Analytical & Formulation Development

Status: Active
CompanyIMAB Biopharma
LocationSan Diego, CA
Expiration2023-05-01
How to Apply

For consideration of any open positions, please send your resume to:
HRDEPT@i-mabbiopharma.com

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 LinkedInTwitter and WeChat.

 

The (Associate) Scientist, Analytical & Formulation Development will support the US CMC Team

Location: San Diego, California

 

Responsibilities:

 

  • The candidate will support 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
  • Support to design various compatibility studies, guide selection of appropriate container closure systems, and provide input for injection device design.
  • 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.
  • Maintain current knowledge of latest scientific and technical trends in the field.

 

Qualifications:

 

  • BS with 1-2 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 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 role is based in San Diego, CA

 

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