JSR Micro, Inc.

Artificial Intelligence

• Reporting directly to KBI’s Chief Strategy Officer.
• Co-develop an AI draft scoring prototype.
• Test prompting strategies and model evaluation.
• Analyze deviation metadata and trends.
• Build prototype deviation heatmaps.
• Assist in building automated reporting logic.
• Create Power BI dashboards or Python scripts.
• Prepare explanation materials and summaries.

Biomanufacturing Quality Data – Applied AI Intern

Technical Project Manager

• Lead end-to-end delivery of cybersecurity initiatives such as risk remediation and compliance initiatives
• Manage ServiceNow projects, including platform implementations and process optimization
• Serve as Scrum Master for Agile teams, facilitating sprint planning, daily standups, and retrospectives
• Act as the primary point of contact between technical teams, business stakeholders, and leadership
• Ensure cybersecurity projects adhere to regulatory and compliance frameworks
• Develop and manage project budgets, forecasts, and resource plans

IT Project Manager

Compliance

• Provide global oversight for SAP system validation across all SAP modules (e.g. SAP S/4HANA, MM (IM), EWM, QM, PP, GRC, and Solution Manager, etc.) and support integrations.
• Lead validation direction and approval of SAP lifecycle deliverables including URS, FRS/FS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ, CSV Plans, Validation Summaries, and Release Documentation.
• Manage and provide oversight of managed validation services for SAP implementation, upgrade, and enhancement projects.
• Provide SAP validation review and approval for SAP-related change controls, CAPAs, and deviations, ensuring all impacts are properly assessed, documented, and resolved.
• Support SAP data integrity initiatives , including validation and compliance of SAP controls, audit trails, electronic signatures, segregation of duties (SoD), access controls, and data lifecycle governance.
• Provide SAP compliance expertise and input for global Policies, SOPs, and Templates for SAP enterprise systems.
• Serve as a key SAP validation SME supporting audits, regulatory inspections, and internal quality reviews.

SAP Principal IT Validation, Compliance

Program Manager

• Dual role managing both Drug substance at KBI and Drug product Fill and Finish services with KBI
• Ensures the appropriate development and control of BDS development
• Provides leadership in managing the KBI-PMO business and establishing client relationships
• Manages project timelines through all phases of development
• Develops, manages, and updates project plans
• Communicates project status, progress, timelines, and changes to all relevant personnel
• Schedules, facilitates, and documents program related client team meetings
• Leads cross-functional teams without direct authority
• Analyzes risk, establishes contingency plans, and identifies trigger events
• Oversees Drug product program portfolio of increased complexity
• Manages the technical and strategic development of the program
• Responsible for staff compliance to PMO project delivery processes and business monitoring tools
• Hosts clients or represent KBI at client site including Executive Steering Committee meetings

Global Director – Program Management

Project Manager

• Lead end-to-end planning and execution of SAP S/4HANA changes, including design, configuration, testing, validation, and cutover
• Define project scope, objectives, and success criteria in collaboration with business and IT stakeholders
• Drive Agile and hybrid delivery frameworks, including sprint planning, backlog grooming, retrospectives, and velocity tracking using Jira and Confluence
• Coordinate cross-functional teams (Finance, Supply Chain, Manufacturing, Quality, and IT) to ensure alignment of business processes and system capabilities
• Oversee Computer System Validation (CSV) and documentation activities in accordance with 21 CFR Part 11 and GAMP 5 principles
• Manage project budgets, forecasts, timelines, and vendor deliverables to ensure on-time, in-scope, and compliant delivery
• Provide oversight of technology vendor resourcing
• Facilitate discussions regarding data integration and governance
• Early risk identification and management; maintain robust risk, issue, and change management processes in compliance with PMO governance and CSV requirements
• Facilitate executive-level reporting, steering committee meetings, and stakeholder communications
• Lead definition, tracking, and management of SAP success measures
• Drive continuous improvement and adoption of Agile methodology across SAP programs
• Serve as the SAP IT organizational change management lead
• Serve as a key liaison between IT, QA, Validation, and Business Process Owners to ensure regulatory readiness and audit compliance
• Champion SAP technology best practices