Project Leader/Scientist II - Analytical Development

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

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary:

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 will oversee day-to-day execution of method development activities while defining analytical strategies, coordinating cross-functional efforts, and managing internal and client-facing deliverables.

This role serves as a key technical and client-facing lead for assigned programs, ensuring high-quality data generation, clear communication, and adherence to company procedures and applicable quality standards appropriate for development-stage work. The Project Leader will also mentor and support scientific staff and contribute to a collaborative, solutions-driven development environment.

Responsibilities:

• Serve as technical and people leader for development-stage programs, providing oversight and coordination of intra-team and cross-functional efforts across analytical development, process development, and project management. Act as a primary scientific point of contact for clients and provide clear, timely communication on program status, risks, and strategy to internal leadership.
• Provide technical leadership and hands‑on support for analytical method development, optimization, and lifecycle advancement across development programs, including early-phase through late-phase activities, as appropriate. This includes method establishment, development, fit‑for‑purpose assessments, and readiness for qualification or validation as programs advance.
• Oversee and review technical documentation and deliverables associated with development activities, including study plans, method development reports, technical summaries, ELNs, and client‑facing reports, ensuring scientific rigor, clarity, and alignment with regulatory expectations for development-stage programs.
• Maintain a broad and current understanding of state-of-the-art analytical techniques and scientific principles relevant to biologics development. Provide technical mentorship and serve as an internal subject‑matter expert within key analytical disciplines, supporting troubleshooting, method strategy, and innovation.
• Manage, mentor, and develop Scientists, Associates, and supporting staff, including onboarding, role clarity, performance feedback, and career development. Communicate expectations clearly and ensure team members understand departmental procedures, quality standards, and development timelines.
• Support laboratory operations, including organization, supply and reagent management, and documentation practices, to ensure efficient execution of development activities in compliance with internal procedures and quality systems.
• Periodically assess workload, resource needs, and staffing requirements to support current and upcoming development programs. Participate in workforce planning, preparation of role descriptions, candidate interviews, and hiring recommendations for new or evolving positions.
• Ensure adherence to safety, quality, and compliance requirements, modeling safe laboratory practices and holding team members accountable to the same standards.

Requirements:

• Education and Experience
  • Ph.D. with 2+ years of directly related experience; or M.S. with 7+ years of related experience; or B.S. with 10+ years of related experience Prior experience must include direct people management or team leadership responsibilities.
• Technical Expertise
  • Demonstrated analytical method development experience across a broad range of techniques commonly used in biologics development, including but not limited to
    • ELISA and other ligand-binding assays Liquid chromatography–based methods (e.g., HPLC/UPLC)
    • SDS-PAGE and related gel-based techniques
    • Capillary electrophoresis–based methods (e.g., CE-SDS, icIEF)
  • Experience supporting methods through development, optimization, troubleshooting, and advancement across program phases is required.
• Client and Communication Skills
  • Strong written and verbal communication skills with the ability to clearly convey technical concepts to internal teams and external stakeholders.
  • Client‑facing experience is highly preferred, including direct interaction with sponsors, participation in technical meetings, and presentation of data and recommendations.
• Leadership and Work Style
  • Proven leadership capabilities with the ability to manage, mentor, and develop scientific staff while fostering collaboration across multidisciplinary teams.
  • Highly organized and able to operate effectively in a fast‑paced, multi-program environment, balancing competing priorities while maintaining a professional and positive demeanor. Demonstrated ability to adapt productively to changing priorities and handle additional responsibilities as needed.

Salary Range:

$110,000 - $138,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.