Analytical Development Lead – Biologics Programs

NCBioImpact; Durham (NC); On-site; USD 110,000 - 138,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Project Leader in Analytical Development to guide method development programs for biologics.

You will lead cross-functional teams, mentor scientists, and ensure data quality and regulatory readiness across development stages. The role emphasizes collaboration with clients, technical strategy, and hands-on support for method establishment, optimization, and lifecycle advancement, from early phase to qualification and validation.

Qualifications

• PhD with 2+ years of related experience, or MS with 7+ years, or BS with 10+ years; direct people management experience preferred.
• Demonstrated analytical method development experience across biologics with ELISA, LC-based methods, and gel-based assays.
• Strong written and verbal communication with client-facing experience is highly valued.

Responsibilities

• Lead development-stage programs across analytical development, process development, and project management.
• Provide hands-on leadership for method development, optimization, and lifecycle advancement.
• Oversee documentation and ensure scientific rigor and regulatory alignment for development activities.
• Mentor scientists and staff, guiding onboarding, performance feedback, and career growth.
• Coordinate cross-functional efforts and communicate program status, risks, and strategy to clients and internal leadership.
• Support laboratory operations and maintain quality systems and safety practices.
• Assist with workforce planning and hiring for new or evolving positions.

Skills

Analytical method development

Cross-functional leadership

Scientific mentoring

Education

PhD or MS or BS with related experience

Tools

ELISA

HPLC/UPLC

SDS-PAGE

CE-SDS/icIEF

Job description

KBI Biopharma, Inc. seeks a Project Leader in Analytical Development to guide method development programs for biologics.

You will lead cross-functional teams, mentor scientists, and ensure data quality and regulatory readiness across development stages. The role emphasizes collaboration with clients, technical strategy, and hands-on support for method establishment, optimization, and lifecycle advancement, from early phase to qualification and validation.