Denver, CO 80209

303.717.0852 vanhorn.erik@gmail.com
https://www.linkedin.com/in/erikvanhorn1

Erik Van Horn

S ENIOR L EVEL M ANUFACTURIN G O PERATIONS M ANAGER

PRODUCTION PLANNING LEAN MANUFACTURING PROJECT MANAGEMENT PROCESS IMPROVEMENTS
Identify and accelerate strategic manufacturing measures that strengthen performance,
productivity, and cost containment, with sustained multimillion-dollar results
Quality-driven lean manufacturing and operations leader/strategist with scale-up, commercialization, and compliance
expertise; focused on profitable production, staff leadership, savvy workforce utilization, and production planning
excellence. Success in increasing productivity and profits in startup to enterprise organizations, with extensive change
management expertise. Skilled in managing biopharmaceutical manufacturing processes, site operations / production
planning from design to commercial delivery. Open to relocation.

Rapidly secure and deliver manufacturing and supply chain success, process engineering, and quality systems
development in diverse leadership roles, identify areas of maximum ROI, develop efficiency solutions, and
increasing accountability.

Actively seeking an operations leadership role where impacting year-over-year manufacturing standards,
streamlining efficiencies, and strengthening performance are held at a premium.

A R E A S O F S TR E NG T H

LEAN / Six Sigma / Operational Excellence

Capacity Models / Capacity Planning
Manufacturing Operations Analytics
Multivariate Statistical Analysis
Manufacturing Operations Planning
Lead Top-Performing Technical Teams
Supply Chain and Manufacturing Leadership

Establish Document Controls

Strategic Resource Allocation
Product Development / New Product Introduction
Author Technical/Regulatory Documents
Interact with Regulatory Agencies
Production and Project Scheduling
Biologics Downstream Processing

C A R E E R H IS TO R Y
2014 to Present: Konfab LLC, Denver, CO
Principal Consultant
Consulting with executives and managers at GMP manufacturers to develop integrated strategies in operations, IP, and
regulatory filing. Providing solutions for production and supply chain operations, unleashing productivity gains for client
accounts. Strategic development of quality systems; comprehensive international shipping solutions for biologic products;
turnaround of product loss and customer dissatisfaction.

500% increase of throughput for FDA GMP compliant sterile media manufacturing; capacity planning, process engineering
input, design, specifications, as well as supplier identification, qualification, negotiated supplier agreements, and auditing.

Achieved zero defect rate by delivering procurement standards and changes in facilities, equipment, procedures, and
processes. Implement safety systems including OSHA compliance and introduction of lean manufacturing. Authored
transfer documentation to establish CMO in target market countries.

Engineered a fast turnaround revision of quality systems under medical drug device GMP and prepare for external audits
and regulatory filings under FDA cGMP, QSR, ISO 9000, and ISO 14385.

Scalable Business Process: Develop Quality Management Systems (QMS) including design, change and management
controls and provide documentation, training, and support for each clients leadership and workforce.

50% reduction in cycles times by designing an efficient quality assurance product release process.

Lean Six Sigma (LSSGB) certificate program in progress, Villanova University.

2002 to 2014: Amgen, Inc., Longmont, CO
Senior Manager, Supply Chain 2012 to 2014
Repeatedly promoted to greater leadership roles as operations and supply chain expert in planning, organization, and
workforce utilization, as well as efficiency and productivity operations in manufacturing; led team efforts for site tactical
planning, production scheduling, project coordination, capacity analysis, and lean manufacturing daily meetings.

30% improvement in direct labor allocation efficiency for 600 headcount manufacturing site. Recognized by executive

Erik Van Horn Page 2

management with a Corporate Excellence Award.

Generated detailed KPI (Key Process Indicators) planning, tracking, budget planning, workforce training, and performance
review standards. Presented updates and forecasts for S&OP.
Met all delivery targets and minimized downtime: Developed production plans and shutdowns for two manufacturing
plants with multiple licensed/clinical products.
Planned operations for $75MM capital investment in two new downstream processing lines.
Coached and developed team of schedulers and project managers; recruited/directed senior level project and
management consultants. Delivered business and manufacturing process training.
Collaborated daily with inspectors during regulatory audits with FDA and foreign regulators; wrote FDA 483 responses.
Provided technical support for capital projects, including negotiation with program managers and developed maintenance
and support of manufacturing dashboard that interfaced to OSIsoft PI System, LIMS, MES, and ERP.

Senior Specialist, Manufacturing - 2009 to 2012

Directed complete rework of facility, process lines, and licensing for two new processes; led process owner, manufacturing
engineer and technical support group in change controls, manufacturing organization training deliverables, and plant LEAN
operations. Site meeting discussions and planning included SOP and MBR (Master Batch Record) writing, engineering support
and validation, and change controls delivery.

Led cGMP compliance and safety including systems under PSM (Process Safety Management) regulation; directed
specialist group developing SOPs and MBRs, change records, all ERP setup, and the technical support group.

Modernized manufacturing controls and techniques using lean concepts: VSM (Value Stream Mapping), Kaizen, 5S, and
daily accountability. Led ERP system conversion and MES implementation.

Authored CMC FDA filing sections including viral safety evaluation; executed/supported validation IQ/OQ/PQ/PV for
downstream and support processes.

Directed product quality risk assessments using FMEA, Kepner-Tregoe, and Hazop, collaborating with global technology
and management teams. Drove Defense in Depth projects. Completed FAT, design reviews and quantitative risk analysis.

Reduced downtime during viral contamination response and plant restart. Authored supporting technical assessments.

Oversaw tech transfer workstream between local and offshore sites. Managed DCS-MES integration, multiple Kaizen and
VSM sessions, and developed/delivered automated manufacturing dashboard supporting executive decision-making.

Led comprehensive improvements to drug substance aseptic filling, root cause analysis (RCA), eliminated contaminations,
and improved compliance that resulted in successful follow-up of FDA inspections.
Associate Manager, Manufacturing 2004 to 2008
Led manufacturing operations in commercial downstream processing including recruitment, development, and evaluation of
personnel and line management. Implemented safety practices, LEAN, and operational excellence. Successfully established
multivariate statistical batch review processing using SIMCA and PI.

Promoted to manage supervisors and develop LEAN manufacturing principles with a multitude of direct manufacturing
and support system projects, documentation updates, and reviews.

Led non-conformance investigations providing root cause analysis, deviation protocols, and CAPA records.
EARLY CAREER
Amgen, Inc., Longmont, CO - Supervisor II
Vitro Biopharma / Vitro Diagnostics, Inc., Aurora, CO - Technology Director / Production Manager/Scientist

E D U C A T I O N / P R O F E S S IO N A L T R A IN I NG
University of Colorado, Boulder

B.S. in Chemical Engineering

Amgen Leadership Development Training: Project Management, Change Management, Six Sigma, Lean Champion
FDA Regulatory Education for Industry training
Investigator RCA
TECHNOLOGY PROFICIENCIES
Modeling: Excel based operations dashboards and capacity models based on Excel, SchedulePro, and Virtecs
Software: Trackwise | Intelligen Super Pro / Schedule Pro | SAP | SM-LIMS | Cognos | Simca | Unicorn | DeltaV
Intellution|Schneider Electric Citect | Ladder | OSI PI Data Historian | MS Project | Primavera | R | SAS | Minitab