Program Integration Associate II

KBI Biopharma; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Program Integration Associate II to coordinate planning, integration, and execution-readiness across process development and CMC programs.

The role applies technical and operational knowledge to support facility fit assessments, BOM forecasting, GMP-regulated activities, and external vendor coordination. Reporting to the Director, Program Integration, you will manage multiple projects with limited supervision, communicate risks and milestones, and help ensure

Qualifications

• Bachelor’s degree with 2–5 years of relevant experience.
• Knowledge of GMP/GLP and regulated documentation environments.
• Ability to coordinate multiple projects and stakeholders.

Responsibilities

• Coordinate facility fit and cadence assessments by compiling inputs and aligning stakeholders.
• Develop, maintain, and analyze BOM forecasts to support material planning and communicate updates.
• Coordinate cross-functional deliverables for regulatory submissions and program execution.
• Coordinate viral clearance lab readiness and study execution activities, including scheduling and documentation.
• Develop and maintain program dashboards, trackers, and metrics to communicate status, risks, milestones.

Skills

Cross-functional coordination

Strong written and verbalcommunication

Documentation management

Education

Bachelor of Science in Chemical Engineering or related field

Master's degree (preferred)

Job description

Position Summary: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 prioritiesPosition Responsibilities:Coordinate facility fit and cadence assessments by compiling technical and operational inputs, identifying scheduling constraints or resource gaps, and facilitating alignment with functional stakeholdersDevelop, maintain, and analyze development-stage BOM forecasts to support material planning, identify forecasting gaps, and communicate updates to program stakeholdersCoordinate cross-functional deliverables supporting regulatory submissions and program execution activities, ensuring alignment of timelines, priorities, and deliverablesCoordinate viral clearance laboratory readiness and study execution activities, including virus spiking, chromatography and viral filtration operations, laboratory scheduling, sample logistics, inventory management, and study documentationDevelop and maintain program dashboards, trackers, and metrics used to communicate program status, risks, milestones, and planning activitiesCoordinate development, review, and maintenance of CMC documentation supporting viral clearance, cell banking, process development, and regulatory submission activitiesManage 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 reviewsMinimum 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.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.