Analytical Development Scientist

Xsome Biotech, Inc.; Raleigh (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Xsome Biotech, Inc. in Raleigh, NC is seeking an Analytical Development Scientist to lead analytical development activities for exosome/particle characterization and support GMP manufacturing.

You will develop standard analytical methods for biologics, coordinate method transfer and qualification, and perform experiments with protein assays, FACS, NTA, SDS-PAGE, and Western Blot, contributing to IND regulatory readiness.

Qualifications

• MS in scientific field; higher degree preferred.
• 2+ years analytical development experience.
• Experience developing phase-appropriate analytics for release/characterization of biologics.
• Hands-on with analytical techniques: protein assays, FACS, spectrophotometer, NTA, SDS-PAGE, Western Blot.
• Strong understanding of IND regulatory requirements.

Responsibilities

• Responsible for analytical development activities for exosome/particles.
• Develop standard analytical methods to characterize biologics, coordinate method transfer and qualification.
• Assist with troubleshooting, identification, and resolution of technical issues related to investigation reports.
• Support process development and GMP manufacturing.
• Perform experiments and data analysis and interpretation.
• Work collaboratively and effectively as part of a team.

Skills

Analytical method development

Statistical design

Data analysis

Team collaboration

Education

MS in scientific field

Tools

FACS

Spectrophotometer

NTA

SDS-PAGE

Western Blot

Job description

Analytical Development Scientist
Raleigh, NC, United State

Job Description for Analytical Development Scientist

Key responsibility:

Responsible for analytical development activities for exosome/particles

Develop standard analytical methods to characterize biologics, coordinate analytical method transfer and qualification

Assist with troubleshooting, identification, and resolution of technical issues associated with investigation reports

Support process development and GMP manufacturing

Perform experiments and data analysis and interpretation

Work collaboratively and effectively as part of team

Qualifications:

M.S. in scientific with a higher advanced degree preferred

2+ year analytical development experience

Demonstrated experience in development of phase-appropriate analytics for release and characterization of biological products

Hands-on experience in developing various analytical techniques, protein assays, FACS, spectrophotometer, NTA, SDS-PAGE, Western Blot

Deep understanding of statistical experimental design and data analysis. Sound understanding of regulatory requirement related to INDs