Program Integration Associate II

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 Masters 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.