Program Integration Associate II

KBI Biopharma • Durham, NC

1d

About The Position

The Program Integration Associate II independently coordinates planning, integration, and execution-readiness activities across process development and CMC programs. The position applies technical and operational knowledge to support facility fit assessments, BOM forecasting, regulatory readiness activities, viral clearance laboratory operations, and external vendor coordination. The Associate II identifies routine risks, coordinates cross-functional deliverables, supports execution of viral clearance studies, and facilitates alignment across stakeholders to ensure successful program execution. Reporting to the Director, Program Integration, this role supports efficient and scalable program execution while independently managing assigned activities and priorities.

Requirements

• Bachelor of Science degree in Chemical Engineering, Biochemical Engineering, Biology, Microbiology, Biochemistry, Biotechnology, or related scientific discipline with 2-5 years of relevant experience; or Master's degree with 0-2 years of relevant experience.
• Working knowledge of biologics development, CMC activities, process development workflows, regulatory submissions, and/or manufacturing operations.
• Familiarity with GMP, GLP, and regulated documentation environments.
• Demonstrated ability to coordinate multiple projects, priorities, and deliverables simultaneously with limited supervision.
• Ability to analyze information, identify risks or gaps, and recommend solutions within established practices.
• Experience coordinating activities across cross-functional teams.
• Strong written and verbal communication skills with the ability to effectively communicate technical and operational information.

Responsibilities

• Coordinate facility fit and cadence assessments by compiling technical and operational inputs, identifying scheduling constraints or resource gaps, and facilitating alignment with functional stakeholders
• Develop, maintain, and analyze development-stage BOM forecasts to support material planning, identify forecasting gaps, and communicate updates to program stakeholders
• Coordinate cross-functional deliverables supporting regulatory submissions and program execution activities, ensuring alignment of timelines, priorities, and deliverables
• Coordinate viral clearance laboratory readiness and study execution activities, including virus spiking, chromatography and viral filtration operations, laboratory scheduling, sample logistics, inventory management, and study documentation
• Develop and maintain program dashboards, trackers, and metrics used to communicate program status, risks, milestones, and planning activities
• Coordinate development, review, and maintenance of CMC documentation supporting viral clearance, cell banking, process development, and regulatory submission activities
• Manage timelines, deliverables, documentation, and communication associated with external viral clearance, MCB, and other development service providers.
• Maintain and improve standardized templates, repositories, and documentation tools supporting Program Integration and CMC planning activities.
• Coordinate documentation readiness activities and support responses related to audits, inspections, and regulatory reviews

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level