Petar Kecman

About Petar Kecman

Accomplished Biopharmaceutical Leader with proven success in managing complex operations, delivering innovative solutions, and executing critically strategic programs while maintaining a high level of compliance in an FDA regulated environment. I have a strong ability to maintain an effective balance between the big picture, strategic thinking, and transformation, while focusing on the details necessary for delivering program execution. Accomplishments include: Project Manager for capital programs budgeted >$40M. Executed full-scope of programs successfully meeting all critical success factors:• Safety: man-hours through full execution with no lost-time incidents• Schedule: On-Time delivery to meet yearly site budget targets• Budget: Delivered on-budget through staffing management and daily execution management to ensure problems were efficiently resolved to avoid delays• Quality: High-Level of right-first-time execution to deliver against FDA commitments Technical Automation Lead on >$150M of capital projects to increase site capacity by removing bottlenecks, streamlining the process, and adding new equipment to the plant alongside on-going commercial operations. Led design improvements to ensure operational success of area go-live for commercial operations that included:• CIP cycle development savings to reduce load on CIP skids by 20%• Modified maintenance procedures per risk assessment to focus on critical devices enabling site to save >1 man-month in yearly maintenance time on equipment• Reduced Harvest Capture and Clarification cycle time by 10%• Media batch/transfer modifications to reduce overall cycle time by 25%. Reduced backlog of overdue quality items (change control action items, deviations, CAPAs, work orders, training) within the AE department by >90% within 3 months

Experience

1. Associate Director - Operations Product Leader

   Brammer Bio

   Apr 2018 — Present · Cambridge, MA, US

   Lead operational / production readiness for late stage clinical and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets.

Education

• Tufts University

  Master of Science (MS), Engineering Management

  2012 — 2014

• Boston University

  Bachelor of Science (BS), Biomedical/Medical Engineering

  2004 — 2008

Skills

• Cgmp
• Technical Writing
• Process Engineering
• Instrumentation
• Root Cause Analysis
• Continuous Improvement
• Cross-Functional Team Leadership
• Quality System
• Quality Systems
• V&V
• Validation
• Process Simulation
• Troubleshooting
• Product Development
• Fmea
• Testing
• Process Development
• Gmp
• Change Control
• Design of Experiments
• Manufacturing
• Engineering
• Microsoft Office
• Automation
• Fda
• Biomedical Engineering
• Medical Devices
• Capa
• 21 Cfr Part 11