Project Leader/Scientist II

Position Summary

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.

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.

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.

KBI Biopharma, Inc.

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.

If you are hired, you understand that either KBI Biopharma, Inc. or I can terminate our employment at any time and for any reason, with or without cause and without prior notice. You understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. You attest with your signature below that you have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. You authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information you have provided is untrue, or if you have concealed material information, you understand that this will constitute cause for the denial of employment or immediate dismissal.