Steve Wong
Medical Affairs professional focuses on driving performance through learning, technology, and the practice of innovation.
- Role
- Director, Medical Program Management, Migraine at AbbVie
- Location
- Lake Forest, IL, US
- LinkedIn followers
- 500 followers
About Steve Wong
ASQ certified Quality Manager with 25+ years GxP experience in Medical Affairs operations, leading global technology transfers, pharmaceutical API and drug product technical support, and small molecules drug discovery. Adaptable and team oriented, experienced in resolving complex manufacturing problems and providing cost saving solutions. Successful in managing cross-countries technology transfer projects, regulatory variations submissions and strategy setting. Experienced in small molecule API manufacturing from development to pilot to commercial scale, Drug product manufacturing,CMO due diligence audit, analytical applications, process validation, compliance gap analysis, and process troubleshooting.Experienced in the Therapeutic Areas of Oncology, Women’s Health, Specialty/Metabolics. Address MOH deficiency questions, Risk assessments and remediation, impurity profile evaluation, statistical analyses, HPLC and other analytical instrumentation, lean/six sigma methodologies, tech transfer, systematic problem solving, multicultural/multinational experience.
Experience
Director, Medical Program Management, Migraine
Jan 2022 — Present · Mettawa, IL, US
Education
The University of Hong Kong
BSc, Chemistry
University of Illinois Chicago
PhD, Medicinal Chemistry
Skills
- Technology Transfer
- Statistics
- Cross-Functional Team Leadership
- Continuous Improvement
- Process Improvement
- Chemistry
- Leadership
- Medicinal Chemistry
- Pharmaceutical Industry
- Gmp
- Quality System
- Multinational
- Drug Product
- Apis
- Capa
- Gxp
- Hplc
- Six Sigma
- Quality Assurance
- Drug Discovery
- Validation
- Change Control
- Sop
- Root Cause Analysis
- Chromatography
- Analytical Chemistry
- Biopharmaceuticals
- Quality Auditing
- CRO
- Quality Control
- Ectd
- Regulatory Affairs
- Manufacturing
- Drug Development
- Regulatory Requirements
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