Open to opportunities

Anna Spann

@annaspann

Senior analytical quality leader enabling GMP-compliant clinical cell therapy testing through oversight, training, and deviation management.

United States

Message

What I'm looking for

I’m looking to lead multi-site analytical QC quality oversight for clinical-stage cell therapy, partnering across QA, Technical Operations, and CDMOs to ensure on-time release, inspection readiness, and continuous improvement.

I lead analytical Quality Control oversight for outsourced testing operations across a multi-site U.S. CDMO network supporting clinical-stage cell therapy programs, ensuring readiness for manufacturing, release, stability, and development milestones. I travel 30–40% to partner sites for hands-on technical oversight, analyst training, troubleshooting, and support during method transfers and time-sensitive clinical manufacturing runs.

As a primary QC liaison, I resolve complex analytical, compliance, scheduling, and execution issues while aligning Technical Operations, QA, Supply Chain, and Manufacturing teams. I’ve managed deviation investigations, CAPA execution, and technical assessments to maintain GMP compliance, support inspection readiness, and ensure manufacturing continuity and batch release, including representing potency assay subject matter expert during 2 FDA inspections.

Experience

Work history, roles, and key accomplishments

Current

Senior Scientist, Quality

Current

Galapagos NV

Oct 2024 - Present (1 year 8 months)

Led analytical Quality Control oversight for outsourced testing across a multi-site U.S. CDMO network supporting clinical-stage cell therapy programs, ensuring readiness for manufacturing, release, and stability milestones. Provided hands-on technical oversight during 30–40% travel to partner sites, including method transfers, assay implementation, and real-time resolution of QC issues to maintain

GMP Compliance Outsourced Testing Oversight Method Transfer Potency Assay Support CAPA QC Liaison

Scientist, Quality Control

Bristol Myers Squibb

Apr 2021 - Oct 2024 (3 years 6 months)

Served as a subject matter expert for 8+ analytical methods supporting GMP release and in-process testing across global cell therapy operations. Trained 50+ analysts globally and developed scalable training systems (SOPs, technical curricula, and SCORM modules) to harmonize QC execution and documentation practices.

Analytical Method SME Training program development GDocP Instruction Documentation Harmonization

Senior Bioassay Analyst

KBI Biopharma

May 2020 - Apr 2021 (11 months)

Performed GMP-compliant analytical testing for clinical-stage client programs in a regulated CDMO environment, including cell-based potency and cytotoxicity bioassays. Resolved assay performance issues and authored/revised SOPs and test methods to improve robustness, efficiency, and GMP alignment.

Assay Troubleshooting Batch Disposition Support Data Quality

Senior Research Associate

Bellicum Pharmaceuticals

Oct 2018 - May 2020 (1 year 7 months)

Supported analytical development and Quality Control for clinical-stage CAR-T programs, including executing analytical method transfers to enable phase-appropriate GMP testing readiness. Performed potency and functional bioassays (including AlphaLISA-based testing) and authored/revised SOPs and technical documentation in partnership with Quality Assurance.

CAR T Analytics Analytical Transfer GMP Documentation Assay Lifecycle Management

Senior Manufacturing Associate

MilliporeSigma

Jan 2014 - Mar 2017 (3 years 2 months)

Manufactured GMP oligonucleotide products in a regulated production environment, adhering to batch records, SOPs, and quality system requirements. Performed aseptic fill-finish and supported equipment installation/qualification and process readiness while training personnel on GMP documentation and safety practices.

GMP Manufacturing Aseptic Fill Finish Batch Contamination Control Manufacturing Equipment Qualification