ADAM M. VELLER
Angier,NC
Summary
Dynamic, productive leader with extensive industry experience in leading teams to achieve operational excellence, Right First Time (RFT) practices and proactive issue resolution. Proven expertise in Process Development, Technical Transfer, cGMP’s, Process Validation and Change Management. Responsible for fostering a cross-functional collaboration-based approach to problem solving and issue resolution. Recognized for implementation of successful Quality systems, developing, and validating Chromatography operations and demonstrating strong leadership and analytical skills.
Overview
7
7
years of professional experience
Work History
Quality Assurance, Validation Manager
Pfizer
Sanford, NC
01.2025 - Current
- Managed the Quality Assurance Validation-Vaccines team, ensuring on-time and compliant deliverables across all areas of responsibility.
- Provided leadership within a team of nine QAV professionals to uphold rigorous RFT, cGMP compliant metrics and documentation standards.
- Acted as Quality Subject Matter Expert for the site Change Management program.
- Achieved successful, on-time deployment for the new Change Management Quality System (i.e., EQMS).
- Achieved IMEX certification to ensure operational excellence.
- Collaborated with other departments including Development, Project Management, and Regulatory Affairs to ensure successful completion of validation activities.
- Served as PCT Lead for QA Validation-Vaccines Process Centric Team board.
Quality Operations New Products Lead
Pfizer
Sanford, NC
07.2022 - 12.2024
- Led a team of eight quality professionals who were responsible for New Product onboarding/ Technical Transfer, Facility Fit, Quality by Design, start-up/cGMP readiness, Quality Risk Management and Right First-Time execution of clinical production.
Chromatography Subject Matter Expert (SME)
Pfizer
Sanford, NC
07.2018 - 07.2021
- Created a cross-network collaboration and a multi-faceted team of colleagues to define, install, produce, and maintain chromatography operations at Pfizer-Sanford.
- Successfully implemented the Chromatography Method Validation Program at Sanford.
- Successfully validated Chromatography methods for a commercial product for at Sanford.
- Successfully implemented the Resin Re-use Program for the Sanford site.
Education
BACHELOR OF SCIENCE - Biology, Chemistry
ILLINOIS STATE UNIVERSITY
01.1992
Skills
- Quality Assurance
- Regulatory Compliance
- Quality Risk Management
- Change management
- Process Validation
- Technical Transfer
- Chromatography Techniques
- Chromatographic Method Development
- Leadership
- Cross-functional Collaboration
- Effective Communication
- Clinical Production Management
- Analytical Thinking
- Operational excellence
- Quality Assurance Process Optimization
- New Product Onboarding
- Right First Time (RFT) Execution
- Validation Protocols
- Project Management
- CGMP Readiness and Compliance
- Teamwork and Collaboration
- Verbal Communication
- Written Communication
- Data Integrity
- Management
- Supervision
Other Positions
- Process Technology Manager
- Research Scientist
- Technology Scientist
- Process Development Manager
- Small Scale Manufacturing Manager
- Gene Therapy Quality Technical Transfer Lead
- Quality Operations New Products Lead
- QA for Technical Transfer and Labs Manager
Core Experience
- Production/Development: Protein Purification/Purification Development at lab, pilot and production scale; Technical Transfer/Scale-up of production processes; production area management; column chromatography applications including significant hands on experience with resins of all types (Ion Exchange, Reverse Phase, Hydrophobic Interaction, Size Exclusion and Affinity chromatography); pilot and production scale column packing techniques and qualification of columns from lab to production scale (HETP and Asymmetry); Co-System Administrator for Unicorn applications, chromatography method development, execution and validation, chromatography data analysis.
- Quality Assurance: Quality support for New Products, Technical Transfer, Facility Fit/Quality by Design, cGMP readiness, RFT approach of early phase Clinical Production activities from IND through Process Qualification (PPQ), Quality review/approval of Process order/Master Data Requests, review /approval of all cGMP Production and Validation documentation, Analytical Method review & approval for QC, Change Management System Quality SME/ System owner, Continuous Process Improvement and Operational Excellence.
Timeline
Quality Assurance, Validation Manager
Pfizer
01.2025 - Current
Quality Operations New Products Lead
Pfizer
07.2022 - 12.2024
Chromatography Subject Matter Expert (SME)
Pfizer
07.2018 - 07.2021
BACHELOR OF SCIENCE - Biology, Chemistry
ILLINOIS STATE UNIVERSITY
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