John Thomas Mold
Asheville
Summary
Quality Associate recognized for exceptional productivity and precision in task completion. Expertise in regulatory compliance, quality management, and process improvement. Strong problem-solving and communication skills facilitate effective collaboration across departments, ensuring adherence to product standards and operational efficiency.
Overview
20
20
years of professional experience
Work History
Quality Associate III
Baxter International Inc
Marion
06.2025 - Current
- Developed and maintained quality documentation and reports for compliance purposes.
- Collaborated with cross-functional teams to address quality issues effectively.
- Performed root cause analysis on non-conforming products and implemented corrective actions.
- Utilized quality management systems to track defects and improve processes.
- Reviewed and updated standard operating procedures to enhance operational efficiency.
- Performed detailed inspections of product to ensure quality standards were met.
- Collaborated with engineering staff to develop solutions for identified problems with product designs or manufacturing processes.
Principal Research Associate; QC
Sana Biotechnology
Rochester
03.2022 - 11.2025
- Lead the environmental monitoring program at the Rochester GMP manufacturing facility and design practical solutions to resolve EM Quality Control issues.
- Participate in establishment of method suitability-for-use or method validation for in-house testing and equipment.
- Help maintain Quality Control labs and participate in write/review of quality control SOPs, method validation protocols, and reports.
- Analyzed data using relevant software tools for project insights.
- Trained junior staff on laboratory techniques and safety protocols.
Compliance Specialist
Regeneron Pharmaceuticals Inc.
Albany
04.2021 - 03.2022
- Lead and manage deviation investigations, CAPAs, and change controls.
- Reviewing and maintain procedures, policies and other instructional documents with a focus on continuous improvement.
- Responsible for generating and tracking performance metrics.
- Maintains knowledge of current good manufacturing practices cGMPs.
- Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
- Travel to contract manufacturers or business partners, as required (25% or less).
- Maintain required training status on Regeneron specific work instructions and SOP's.
- Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Continuous Process Improvement Implementation.
Process Sciences Associate II
Regeneron Pharmaceuticals Inc.
Albany
02.2018 - 04.2021
- Supports the Process Sciences Department through small-scale laboratory experiments and raw material studies related to production processes for biopharmaceuticals.
- Development and execution of cell culture studies using aseptic technique in shake flasks and bench-scale bioreactors.
- Develop and write protocols for small-scale studies.
- Generate, manage, analyze, and maintain critical data in a highly organized manner.
Manufacturing Associate II
Seattle Genetics
Bothell
08.2016 - 02.2018
- Demonstrate extremely high levels of independent proficiency regarding all upstream activities including assembly/cleaning/sterilization of equipment, preparation of media and solutions, and mastery of all bench top equipment.
- Operate primary upstream process equipment, including stainless fermenter, disposable bioreactors, centrifuge and depth filtration units.
Downstream Assistant Research Scientist
Bristol-Myers Squibb
Syracuse
01.2016 - 07.2016
- Conduct experiments for the purposes of commercial manufacturing support for biopharmaceutical purification and bulk drug substance handling processes consisting of chromatography and viral inactivation.
Aviation Structural Mechanic
United States Navy
Virginia Beach
08.2006 - 05.2011
- Responsible for maintenance of aircraft structures, hydraulic systems, landing gear systems, and wheel/tire assemblies.
- Provided leadership, supervision, and training to all junior sailors as shift supervisor.
Education
Bachelor of Science - Molecular Biology and Biotechnology
Rochester Institute of Technology
Rochester12.2015
Associate of Science - Mathematics and Science
Corning Community College
Corning05.2013
Skills
- Microsoft Word
- Excel
- PowerPoint
- Continuous improvement
- Data analysis
- Corrective action design
- Minitab
- Outlook
- Quality documentation
- Root cause analysis
- Quality management systems
- Method validation
- JMP
- GLP/GMP protocol
- Strong attention to detail
- Great organizational skills
- Strong communication skills
- Technical writing skills
- Excellent experimental aptitude
- Troubleshooting aptitude
Awards
- Navy Good Conduct Award
- Joint Service Achievement Award
- Commendation CMC SEAL Team2
Attributes
- Strong communication and technical writing skills
- Excellent experimental/troubleshooting aptitude
Timeline
Quality Associate III
Baxter International Inc
06.2025 - Current
Principal Research Associate; QC
Sana Biotechnology
03.2022 - 11.2025
Compliance Specialist
Regeneron Pharmaceuticals Inc.
04.2021 - 03.2022
Process Sciences Associate II
Regeneron Pharmaceuticals Inc.
02.2018 - 04.2021
Manufacturing Associate II
Seattle Genetics
08.2016 - 02.2018
Downstream Assistant Research Scientist
Bristol-Myers Squibb
01.2016 - 07.2016
Aviation Structural Mechanic
United States Navy
08.2006 - 05.2011
Bachelor of Science - Molecular Biology and Biotechnology
Rochester Institute of Technology
Associate of Science - Mathematics and Science
Corning Community College