Analytical Scientist - Protein Analytics & Formulation SME

KBI Biopharma, Inc.; Durham (NC); On-site; USD 84,000 - 115,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an Analytical Scientist to join the Analytical and Formulation Sciences team in Durham, NC.

This role targets a PhD-level scientist with deep protein analytics experience to drive innovation and analytical testing for client programs from early development through late-stage and commercialization for biotherapeutics. The position emphasizes method development, qualification/validation, formulation strategies, and collaboration with cross-functional teams to ensure

Qualifications

• PhD or MS with required years of experience as listed in the posting.
• Expertise in protein analytics and analytical method development.
• Familiar with CGMP and GDP practices; strong data presentation skills.

Responsibilities

• Execute and interpret experiments contributing to project goals.
• Serve as SME for analytical methods and troubleshooting.
• Design analytical experiments for formulation, method development, qualification/validation and stability programs.
• Develop strategies to support product development and regulatory submissions.
• Generate high-quality documentation for publication and regulatory review.
• Collaborate with cross-functional teams including process development, manufacturing, QA and program management.
• Mentor junior scientists and review data and reports.

Skills

HPLC/UPLC

Capillary Electrophoresis

UV/Fluorescence

Biophysical characterization

Protein analytics

Education

PhD in Biophysics/Biochemistry/Analytical Chemistry/Biochemical Engineering

MS with 5 years related experience

BS with 7 years related experience

Tools

SDS-CGE/ icIEF

CGMP knowledge

Data analysis software

Job description

KBI Biopharma, Inc. is seeking an Analytical Scientist to join the Analytical and Formulation Sciences team in Durham, NC.

This role targets a PhD-level scientist with deep protein analytics experience to drive innovation and analytical testing for client programs from early development through late-stage and commercialization for biotherapeutics. The position emphasizes method development, qualification/validation, formulation strategies, and collaboration with cross-functional teams to ensure