Project Leader/Scientist II

KBI Biopharma•Durham, NC

About The Position

The Analytical Development (AD) unit executes analytical activities supporting the development of biologic drug substances and drug products from early development through late-phase support manufacturing. The team provides analytical leadership for non-GMP and early-phase GMP programs, partnering closely with Process Development, Formulation Development, Manufacturing, Regulatory, and clients to accelerate development timelines while maintaining scientific rigor and quality. The Project Leader/Scientist II – AD serves as the technical and project lead for development-stage analytical programs, providing scientific leadership, coordinating cross-functional activities, managing client communications, and driving execution of analytical deliverables. This role is heavily focused on PD Support activities, including analytical strategy, method development oversight, investigational studies, troubleshooting, and supporting rapid program progression from development through early clinical manufacturing. The Project Leader is responsible for ensuring all work is conducted in accordance with company procedures, applicable regulatory requirements, and current Good Manufacturing Practices (cGMP) when appropriate.

Requirements

Ph.D. with 3+ years of directly related industry experience, M.S. with 7+ years, or B.S. with 10+ years in analytical development supporting biologics.
Demonstrated experience leading cross-functional analytical development programs and interacting directly with clients.
Strong technical knowledge of biologics analytical development, characterization, method development, and early-phase product support.
Excellent scientific writing, communication, organization, and project management skills.
Ability to lead multiple fast-paced development programs while maintaining high-quality deliverables and client satisfaction.
Previous people management or demonstrated scientific leadership experience.
Working knowledge of cGMP regulations and analytical development supporting biotechnology-derived products.

Nice To Haves

Previous experience leading scientific teams or direct people management is strongly encouraged.

Responsibilities

Lead analytical support for development-stage biologics programs, which may include method development, method establishment, method qualification, analytical testing and data trending, investigational studies, formulation support, characterization testing, and non-GMP/early-phase analytical activities.
Serve as the primary analytical project leader for assigned development programs by coordinating cross-functional activities, managing priorities, facilitating internal and client meetings, and ensuring timely delivery of project milestones.
Develop analytical strategies to support early-phase program development, comparability assessments, process development, formulation development, and manufacturing decisions.
Review analytical documentation including study plans, protocols, reports, method development documentation, method qualification packages, and client technical documents to ensure scientific quality and execution readiness.
Provide technical leadership for complex analytical investigations, data interpretation, troubleshooting, and risk assessments.
Build strong client relationships through regular technical discussions, presentations, and consultation on analytical development strategies.
Produce high-quality technical reports and client deliverables suitable for regulatory submissions and development decision-making.
Maintain current knowledge of latest analytical technologies, regulatory expectations, and industry best practices relevant to biologics development.
Support laboratory operations and promote a culture of quality, collaboration, continuous improvement, and safety.
Mentor junior scientists and project leaders.