Project Leader/Scientist II - Analytical Development

KBI Biopharma•Durham, NC

About The Position

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 oversees day-to-day method development activities while defining analytical strategies, coordinating cross-functional efforts, and managing internal and client-facing deliverables. This role is a technical and client-facing lead for assigned programs, ensuring high-quality data, clear communication, and adherence to company procedures and applicable quality standards appropriate for development-stage work. The Project Leader also mentors and supports scientific staff and contributes to a collaborative, solutions-driven development environment.

Requirements

Ph.D. with at least 2 years of directly related experience, or M.S. with at least 7 years of related experience, or B.S. with at least 10 years of related experience.
Prior experience must include direct people-management or team-leadership responsibilities.
Demonstrated analytical method development experience across techniques used in biologics development, including ELISA and other ligand-binding assays, liquid chromatography-based methods such as HPLC/UPLC, SDS-PAGE and related gel-based techniques, and capillary electrophoresis-based methods such as CE-SDS and icIEF.
Experience supporting methods through development, optimization, troubleshooting, and advancement across program phases.
Strong written and verbal communication skills, with the ability to convey technical concepts clearly to internal teams and external stakeholders.
Proven leadership ability to manage, mentor, and develop scientific staff and foster collaboration across multidisciplinary teams.
Highly organized and able to work effectively in a fast-paced, multi-program environment, balance competing priorities, and maintain a professional and positive demeanor.
Ability to adapt productively to changing priorities and handle additional responsibilities as needed.

Nice To Haves

Client-facing experience, including direct interaction with sponsors, participation in technical meetings, and presentation of data and recommendations.

Responsibilities

Provide technical and people leadership for development-stage programs, overseeing and coordinating intra-team and cross-functional work across analytical development, process development, and project management.
Serve as a primary scientific point of contact for clients and communicate program status, risks, and strategy to internal leadership.
Lead and provide hands-on support for analytical method development, optimization, and lifecycle advancement across programs, from early- to late-phase activities as appropriate; establish and develop methods, assess fit for purpose, and prepare methods for qualification or validation as programs advance.
Oversee and review technical documentation and deliverables, including study plans, method development reports, technical summaries, ELNs, and client-facing reports, ensuring scientific rigor, clarity, and alignment with development-stage regulatory expectations.
Maintain current knowledge of state-of-the-art analytical techniques and scientific principles relevant to biologics development.
Provide technical mentorship and act as an internal subject-matter expert in 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 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 enable efficient work in compliance with internal procedures and quality systems.
Assess workload, resource needs, and staffing requirements for current and upcoming programs.
Participate in workforce planning, preparation of role descriptions, candidate interviews, and hiring recommendations.
Ensure adherence to safety, quality, and compliance requirements, model safe laboratory practices, and hold team members accountable to the same standards.