KBI Biopharma · 1 day ago
Project Leader/Scientist II
Durham, NC
Full-time
Onsite
Mid, Senior Level
$101K/yr - $138K/yr
7+ years expKBI Biopharma is a global leader in biopharmaceutical development and manufacturing, dedicated to advancing science and accelerating breakthroughs. The Project Leader will oversee analytical development activities, define strategies, and manage deliverables while providing technical leadership and mentorship to scientific staff.
BiopharmaBiotechnologyHealth CareManufacturing
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
Qualification
Required
+ 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
+ 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 chromatography–based methods (e.g., HPLC/UPLC)
+ SDS-PAGE and related gel-based techniques
+ Capillary electrophoresis–based methods (e.g., CE-SDS, icIEF)
+ Experience supporting methods through development, optimization, troubleshooting, and advancement across program phases is required
+ Strong written and verbal communication skills with the ability to clearly convey technical concepts to internal teams and external stakeholders
+ 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
Preferred
+ Client-facing experience is highly preferred, including direct interaction with sponsors, participation in technical meetings, and presentation of data and recommendations
Benefits
Annual bonus structure for all employees
Medical, dental, and vision coverage
Paid PTO and holidays
401K matching with 100% vesting in 60 days
Employee recognition programs
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Marykay Marchigiani
Chief Financial Officer
Peter Carbone
Chief Operating Officer
Recent News
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2025-11-14
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