Nadene Crain
Principal Engineer cGMPnow
Nadene Crain has 18 years of experience in large capital project execution, project management, technical engineering leadership, process engineering, construction, and qualification management in the pharmaceutical and biopharmaceutical manufacturing industries.
As a Principal Process Engineer, she is a Subject Matter Expert (SME) in process equipment, ATMP GMP Manufacturing, Monoclonal Antibodies, ADCs & Bioconjugation. Her extensive background includes serving as a technical lead and engineering manager for clinical and commercial ADC facility design, HPAPI manufacturing, scale-up, and commercialization.
Nadene holds a B.S. in Mechanical Engineering from Colorado State University and is an active member of the American Society of Mechanical Engineers (ASME) and the International Society of Pharmaceutical Engineers (ISPE).
Seminars
- Laying out practical lessons from translating ADC process into contained, commercial cGMP facility design
- Contextualizing how ADC CQAs drive room classification, layout, zoning, and material/personnel flows
- Exploring approaches to protect operators and contain highly potent payloads and intermediates
- Leveraging single‑use and closed‑system solutions for ADC conjugation, purification, and buffer/media management
