KBI Biopharma

KBI Biopharma

Project Leader/Scientist II

USA - NC - Durham - Emperor Blvd · Mid

Sponsorship not specifiedDetected 104 days ago
Project ManagementGMPScientific WritingLeadershipCommunicationCollaborationPublic Speaking

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About the role

  • 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.
  • 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.

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.
  • 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.
  • Build strong client relationships through regular technical discussions, presentations, and consultation on analytical development strategies.
  • 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.
  • 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 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.

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.
  • Working knowledge of cGMP regulations and analytical development supporting biotechnology-derived products.

Company info

  • I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.