Senior Scientist, Analytical Sciences, Biologics

Arcellx - Germantown, MD (30+ days ago)


Key Responsibilities:

  • Support early stage, and late stage products in analytical sciences
  • Lead analytical method development, validation, transfer and stability evaluations
  • Vendor management and oversight of workflow as required
  • Trouble-shooting of analytical methods
  • Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
  • Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings
  • Support and ensure a smooth transfer of analytical technologies to contract sites
  • Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.

Key attributes:

  • Broad experience in analytical sciences supporting early stage, late stage biological therapeutic products
  • Direct experience with analytical method development, validation, transfer and stability evaluations
  • Familiarity with additional biophysical techniques used in protein characterization is required (iCIEF, CE-SDS,Size-Exclusion, reverse-phase UPLC).
  • A comprehensive understanding of quality attributes, and protein degradation mechanisms as they relate to drug substance and drug product development and quality.
  • Demonstrated technical proficiency of analytical methodologies for drug substance and drug product
  • Experience in regulatory requirements for pharmaceutical products
  • Experience in managing contract analytical organizations is desired
  • Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.
  • Excellent written and verbal communication skills with ability to multi-task.
  • Demonstrated troubleshooting and problem solving skills

Quality System Requirements:

  • Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing

Qualifications and Experience:

  • Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required
  • 6-10 years direct experience analytical development, preferably in a pharmaceutical/biotech industry.

Job Type: Full-time

Education:

  • Master's (Required)

Work authorization:

  • United States (Required)