Project LeaderScientist II Analytical Development

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 chromatographybased methods (e.g. HPLC/UPLC)
    • SDS-PAGE and related gel-based techniques
    • Capillary electrophoresisbased 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: $110000 - $138000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidates 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.

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. If I am hired I understand that either KBI Biopharma Inc. or I can terminate my employment at any time and for any reason with or without cause and without prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.

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.

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. If I am hired I understand that either KBI Biopharma Inc. or I can terminate my employment at any time and for any reason with or without cause and without prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.