Tracy Harris
- Role
- Associate Director, Cmc Regulatory Affairs at GSK
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Tracy Harris
Strategic and accomplished Regulatory Affairs leader with 15+ years of progressive…
Experience
Associate Director, Cmc Regulatory Affairs
Oct 2020 — Present
Drove innovative drug substance regulatory strategies to deliver an accelerated MAA & BLA for two COVID-19 biologic therapeutics with external partners -Headed CMC regulatory strategy for a Phase I monoclonal antibody -Established framework to deliver 100+ global health authority commitments in less than 1 year -Mentored new CMC RA employees and supervised a project manager -Recruited and interviewed key talent for CMC regulatory roles -Served as Japan Subject Matter Expert (SME) for Biopharmaceuticals -Managed migration of registered details from legacy system into Veeva -Earned 13 GSK Global Employee Recognition Awards
Education
Misericordia University
Bachelor of Science (B.S.)
Temple University Graduate School
Master of Science (MS)
Skills
- Fda
- Root Cause Analysis
- Biopharmaceuticals
- Biochemistry
- Trackwise
- Change Control
- Aseptic Processing
- Downstream Processing
- Capa
- Project Management
- Protein Purification
- Gmp
- Lean Six Sigma
- Cell Culture
- Quality Assurance
- Deviation Management
- Mammalian Cell Culture
- Chromatography
- Manufacturing Operations
- Purification
- Regulatory Affairs
- Pharmaceutical Process Development
- Gcp
- Clinical Trials
- Protein Chemistry
- 21 Cfr Part 11
- Sop
- Drug Discovery
- Laboratory
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