Project Leader/Scientist II - Analytical Development

KBI Biopharma•Durham, NC

6d•$110,000 - $138,000

About The Position

The Analytical Development organization at KBI Biopharma supports early- and late-stage development programs through analytical method development, optimization, and technical leadership. The Project Leader oversees day-to-day method development activities while defining analytical strategies, coordinating cross-functional efforts, and managing internal and client-facing deliverables. This role is a technical and client-facing lead for assigned programs, ensuring high-quality data generation, clear communication, and adherence to company procedures and applicable quality standards for development-stage work. The Project Leader also mentors and supports scientific staff and contributes to a collaborative, solutions-driven development environment.

Requirements

Ph.D. with at least 2 years of directly related experience, or M.S. with at least 7 years of related experience, or B.S. with at least 10 years of related experience.
Prior experience must include direct people-management or team-leadership responsibilities.
Demonstrated analytical method development experience across biologics development techniques, including ELISA and other ligand-binding assays, liquid chromatography methods such as HPLC/UPLC, SDS-PAGE and related gel-based techniques, and capillary electrophoresis methods such as CE-SDS and icIEF.
Experience supporting methods through development, optimization, troubleshooting, and advancement across program phases.
Strong written and verbal communication skills, including the ability to clearly convey technical concepts to internal teams and external stakeholders.
Proven leadership skills, with the ability to manage, mentor, and develop scientific staff and foster collaboration across multidisciplinary teams.
Strong organization and ability to work effectively in a fast-paced, multi-program environment, balance competing priorities, adapt to changing priorities, and take on additional responsibilities as needed.

Nice To Haves

Client-facing experience, including direct sponsor interaction, participation in technical meetings, and presentation of data and recommendations.

Responsibilities

Lead and coordinate day-to-day execution of development-stage programs and cross-functional efforts across analytical development, process development, and project management.
Serve as a primary scientific contact for clients and communicate program status, risks, and strategy to clients and internal leadership.
Provide technical leadership and hands-on support for analytical method development, optimization, troubleshooting, and lifecycle advancement, including method establishment, fit-for-purpose assessments, and readiness for qualification or validation.
Oversee and review development documentation and deliverables, including study plans, method development reports, technical summaries, ELNs, and client-facing reports.
Maintain current knowledge of analytical techniques and scientific principles relevant to biologics development; provide mentorship and subject-matter expertise in analytical disciplines.
Manage, mentor, and develop Scientists, Associates, and supporting staff through onboarding, role clarification, performance feedback, and career development.
Support laboratory operations, including organization, supply and reagent management, and documentation practices.
Assess workload, resource needs, and staffing requirements; participate in workforce planning, role description preparation, candidate interviews, and hiring recommendations.
Ensure compliance with safety, quality, and company requirements, model safe laboratory practices, and hold team members accountable to applicable standards.