Senior Scientist I, Biologics Analytical R&D, CMC Biologics Development

📋 Description

• Act as a subject matter expert in BioARD, lead phase-appropriate analytical development strategies
• Execute the buildout of biotherapeutics extended characterization methods to facilitate in-process
• Make lab-based, data-driven, and phase-appropriate contributions to project team and deliver
• Represent key area function in cross-functional project teams, provide hands-on analytical support
• Collaborate and integrate scientific objectives associated with development of new/improved
• Author, review lab notebook, analytical report, and analytical sections of regulatory filings.

🎯 Requirements

• PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology); BS or
• Direct and hands-on experience in mass spectrometry-based characterization of biologics, including
• Working knowledge of mass spectrometry coupled chromatographic separation techniques and
• Familiarity with biologics CE, icIEF, biophysical assays, or binding and functional assays are plus.
• Good written and oral communication skills, and time management skills.
• Ability to work independently and collaboratively across functions.

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Eligible to participate in our short-term incentive programs.