Program Integration Associate II

KBI Biopharma; North Carolina; On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma is seeking a Program Integration Associate II to independently coordinate planning, integration, and execution-readiness activities across process development and CMC programs. The role supports facility fit assessments, BOM forecasting, regulatory readiness, viral clearance lab operations, and external vendor coordination.

Reporting to the Director, Program Integration, the Associate II will identify routine risks, align stakeholders, manage timelines, and develop program

Qualifications

• BS degree in a chemical/biological science with 2–5 years of relevant experience, or MS with 0–2 years.
• 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 with limited supervision.
• Strong written and verbal communication skills for technical and operational information.

Responsibilities

• Coordinate facility fit and cadence assessments with stakeholders.
• Develop and analyze BOM forecasts to support material planning.
• Coordinate cross-functional deliverables for regulatory submissions and execution activities.
• Coordinate viral clearance lab readiness and study execution activities.
• Develop and maintain program dashboards, trackers, and metrics.
• Coordinate development and maintenance of CMC documentation for viral clearance and regulatory submissions.
• Manage timelines, deliverables, and communications with external vendors.
• Maintain standardized templates, repositories, and documentation tools.
• Coordinate readiness activities for audits, inspections, and regulatory reviews.

Skills

GMP/GLP experience

Cross-functional coordination

Documentation management

Risk analysis and mitigation

Regulatory submissions support

Education

Bachelor of Science in Chemical Engineering or related science

Master’s degree with 0-2 years of experience

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 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.