Summary
Overview
Work History
Education
Skills
Timeline
Technical Expertise
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David Jones

Summary

Results-driven pharmaceutical leader with over 25 years of experience in aseptic manufacturing, sterility assurance, and environmental monitoring. Proven track record of leading cross-functional teams, driving regulatory compliance, and implementing innovative technologies across multiple parenteral sites. Recognized for strategic leadership, technical expertise, and consistent support during regulatory inspections.

Overview

14
14
years of professional experience

Work History

Associate Director – Environmental Monitoring & FUME

Indy Parenteral
01.2018 - Current
  • Led Environmental Monitoring (EM) execution across all Indy Parenteral facilities.
  • Directed equipment qualification and developed procedural/training tools to improve floor execution and reduce deviations.
  • Manage the Environmental Monitoring Evaluation Reports system for batch release.
  • Worked closely with suppliers to secure consumable availability and support seamless production flow.
  • Oversaw LTC South site utilities sampling and processing (Water, Gas, Clean Steam).
  • Supported EM operations at RTP, Concord, Lebanon, and LKC sites.
  • Qualified 7 filling lines during new facility start-ups.
  • Conducted Gemba walks for cGMP assessments
  • Acted as Subject Matter Expert during regulatory inspections, front-room interactions and facility tours.
  • Lead mock audits to coach employees on compliance, fostering a strong regulatory culture.
  • Participated in over 40 regulatory inspections, providing expert guidance and support for multiple different agencies and countries.

Associate Director – Sterility Assurance

Indy Parenteral
01.2016 - 01.2018
  • Managed Grade A deviation investigations and change controls.
  • Reviewed Environmental Monitoring Evaluation Reports for batch release.
  • Mentored new sterility assurance investigators and microbiologists.
  • Led creation and approval of process/facility risk assessments and FEMA documentation.
  • Championed quality risk management and mitigation strategies.

Operations Associate (Process Team Leader)

Indy Parenteral
01.2012 - 01.2016
  • Led daily syringe filling operations with cross-functional teams (Engineering, TS/MS, Quality, Automation, Maintenance).
  • Managed clinical trial drug supply manufacturing for Trulicity, Emgality, Taltz, and others.
  • Directed facility and PFS1 start-up activities including EMPQ, Integrated Line PQs, and process validation batches.
  • Executed aseptic process simulations and inspection facility qualifications.
  • Implemented syringe tub reject visualization and inspection accountability technologies.
  • Designed and deployed the globally adopted Syringe Post-Fill Partial Inspection process.

Education

Bachelor of Science - Microbiology

Ball State University
Muncie, IN
05-1995

Skills

  • Team collaboration and leadership
  • Employee development coaching/ mentoring to drive individual and team performance
  • Strategic leadership in environmental monitoring across multiple sites
  • Risk management and mitigation strategy
  • Data analysis/interpretation, Data integrity
  • Regulatory interaction and inspection readiness
  • Compliance regulatory standards (ISO, cGMP, 21 CFR Part 11)
  • Supplier management

Timeline

Associate Director – Environmental Monitoring & FUME

Indy Parenteral
01.2018 - Current

Associate Director – Sterility Assurance

Indy Parenteral
01.2016 - 01.2018

Operations Associate (Process Team Leader)

Indy Parenteral
01.2012 - 01.2016

Bachelor of Science - Microbiology

Ball State University

Technical Expertise

  • Electronic data management systems (i.e MODA)
  • Aseptic techniques
  • Sampling and Monitoring
  • Contamination control
  • Isolator RAB's technologies
  • Pharmaceutical manufacturing processes (Vial, Syringe and Cartridge).

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David Jones