Steve has 14 years of industry experience in CMC product development of cell therapies and virus vaccines in analytical development and strategy, quality control, and CMC regulatory affairs at small biotech and big pharma companies.
Skills include:
- Highly collaborative and adept at working in matrix environments with multiple internal and external stakeholders.
- Expertise in leading drug product and in-process analytical development programs from development through qualification and transfer to QC.
- Quality Control leadership with proven ability to establish compliant control strategies, draft SOPs, perform quality document audits, review quality issues and investigations, and drive product release timelines.
- Extensive global CDMO management experience and SME on technology transfer of analytical control programs.
- Regulatory CMC strategy including extensive experience authoring high-quality CMC content for INTERACT, AMT Designation requests, pIND briefing books, IND, IMPD, QoS, DMF, and agency responses.
- Stability study program management and drug product comparability study design.
- Excellent cross-functional communication and training skills.
