Program Integration Associate II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 80,000 - 100,000; 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 supports facility fit assessments, BOM forecasting, viral clearance studies, and external vendor coordination, reporting to the Director, Program Integration. This position requires coordinating cross-functional deliverables, managing timelines and documentation, and maintaining program dashboards to communicate

Qualifications

• Bachelor of Science degree in Chemical Engineering, Biochemical Engineering, Biology, Microbiology, Biochemistry, Biotechnology, or related discipline with 2-5 years of relevant experience; or Master’s with 0-2 years.
• Familiarity with GMP, GLP, and regulated documentation environments.
• Ability to coordinate multiple projects, priorities and deliverables with limited supervision.

Responsibilities

• Coordinate facility fit and cadence assessments and align with stakeholders.
• Develop, maintain, and analyze BOM forecasts to support material planning.
• Coordinate cross-functional deliverables for regulatory submissions and program execution.
• Coordinate viral clearance lab readiness and study execution activities.
• Develop and maintain program dashboards, trackers, and metrics for status and milestones.
• Coordinate documentation supporting viral clearance, cell banking, and regulatory submissions.
• Manage timelines, deliverables, and communication with external vendors.
• Maintain standardized templates and documentation tools for Program Integration.

Skills

Cross-functional coordination

Written and verbal communication

Project coordination

Stakeholder alignment

Education

Bachelor of Science in Chemical Engineering or related

Master's degree (optional)

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 priorities.

Position 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

Minimum 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 workforce. 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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.