KBI Biopharma
Program Integration Associate II
USA - NC - Durham - Emperor Blvd · Mid
Sponsorship not specifiedDetected 79 days ago
ForecastingLogisticsInventory ManagementCadenceGMPCommunication
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Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- The Program Integration Associate II independently coordinates planning, integration, and execution-readiness activities across process development and CMC programs.
Responsibilities
- Develop, maintain, and analyze development-stage BOM forecasts to support material planning, identify forecasting gaps, and communicate updates to program stakeholders
- Develop and maintain program dashboards, trackers, and metrics used to communicate program status, risks, milestones, and planning 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
- 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.
Company info
- 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.
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