David Circle
Windsor,USA
Summary
Biomanufacturing leader with 10+ years of experience in cGMP-regulated environments, specializing in downstream processing, technology transfer, process optimization, and team development. Proven expertise in chromatography, filtration, deviation investigations, and regulatory compliance. Skilled at managing large-scale biologics production, training personnel, supporting audits, and implementing continuous improvement initiatives in both clinical and commercial manufacturing.
Overview
16
16
years of professional experience
Work History
Technical Trainer – Downstream Manufacturing
Novo Nordisk
09.2023 - Current
- Train biomanufacturing personnel in GMP-compliant downstream operations.
- Develop SOPs, technical training modules, and curricula to standardize processes.
- Support deviation investigations, CAPAs, and regulatory compliance initiatives.
- Collaborate with cross-functional teams to align manufacturing execution with quality standards.
Senior Downstream Specialist
Grifols
02.2022 - 09.2023
- Managed large-scale downstream processes, including filtration and chromatography.
- Directed technology transfers and finite scheduling for GMP operations.
- Provided on-the-floor technical support during deviations and audits.
Master Manufacturing Associate – Downstream
Boehringer Ingelheim
07.2019 - 02.2022
- Supervised shift teams across downstream operations, ensuring GMP compliance.
- Conducted real-time troubleshooting and maintained inspection readiness.
- Supported audit events and regulatory inspections.
Lead Production Technician
AstraZeneca / MedImmune
01.2013 - 04.2019
- Led purification operations and mentored junior technicians during scale-up campaigns.
- Coordinated equipment validation, commissioning, and cleaning protocols (CIP/SIP).
- Utilized automation systems (Rockwell RS3, Unicorn) for real-time process control.
- Contributed to startup operations for new facility.
Purification Technician
AstraZeneca / MedImmune
06.2009 - 01.2013
- Executed chromatography and tangential flow filtration in clinical manufacturing.
- Prepared buffers, performed sampling, and documented batch records under GMP standards.
Education
Bachelor of Science - Biochemistry
Virginia Polytechnic Institute and State University
Blacksburg, VAAssociate of Science - Emergency Health Science
College of Health Sciences (now Radford University)
Roanoke, VASkills
- Biomanufacturing Leadership
- Downstream Process Operations (Chromatography, Filtration)
- GMP Compliance & Audit Readiness
- Technology Transfer & Scale-Up
- Team Training & Development
- Resource Planning & Finite Scheduling
- Automation Systems (DeltaV, Unicorn, Rockwell RS3)
- Continuous Improvement / Lean Methodologies
- Manufacturing Systems: DeltaV, Rockwell RS3, Unicorn, BioMES, Finite Scheduling Tools
- Enterprise Software: SAP, ChemStation, TrackWise, LIMS
- Equipment Expertise: AKTA chromatography systems, Axi-Chrom columns, TFF, CIP/SIP skids
- Documentation & Compliance: SOPs, MBRs, CAPAs, Audit Support
Timeline
Technical Trainer – Downstream Manufacturing
Novo Nordisk
09.2023 - Current
Senior Downstream Specialist
Grifols
02.2022 - 09.2023
Master Manufacturing Associate – Downstream
Boehringer Ingelheim
07.2019 - 02.2022
Lead Production Technician
AstraZeneca / MedImmune
01.2013 - 04.2019
Purification Technician
AstraZeneca / MedImmune
06.2009 - 01.2013
Associate of Science - Emergency Health Science
College of Health Sciences (now Radford University)
Bachelor of Science - Biochemistry
Virginia Polytechnic Institute and State University