Brian Orman
Seasoned Quality & Mfg leader commercial, clinical biotech products at operational & green field sites. Strong compliance history. Platform exp in MAbs, plasma, rProteins, bacterial / viral vaccines, and transgenics.
- Role
- Sr Director, Head of Product Quality Lifecycle Mgmt, Transgenic Quality at Alexion Pharmaceuticals, Inc.
- Location
- Athens, GA, US
- LinkedIn followers
- 500 followers
About Brian Orman
27 years of Biopharmaceutical Leadership in Product Quality, Quality Operations, Manufacturing, Technical Development, and Project Management with seven Fortune 500 companies in FDA regulated environment. Key international experience (Europe and Asia) in transitional change management, green field start-ups, regulatory inspections, and new product launch. Chemical Engineer with M.B.A.
Experience
Sr Director, Head of Product Quality Lifecycle Mgmt, Transgenic Quality
Jan 2017 — Present
Global Head of Product Quality Lifecycle Mgmt team - provide CMC Product Quality stewardship for commercial rare disease products to ensure science and risk based management of regulatory expectations. Site Quality Head of Transgenic Operations network - responsible for ensuring quality assurance, quality control, and quality / regulatory compliance for all transgenic commercial and clinical products.Quality lead, Country Quality / Commercial Distribution expansion into Argentina / LATAM and Central and Eastern European (CEE) regions including due diligence / audits of partners and establishing relevant quality agreements.Quality Integration Lead for late stage clinical asset - developed and drove integration plan consisting of key risks / mitigations, critical supplier interaction activities, and quality management system deliverables to ensure uninterrupted clinical supply to patients.Quality lead, Global Clinical Supply organization advocating for prioritization and cross functional support between Global Operations Quality and R&D Quality teams.
Education
West Virginia University
MBA, Business Administration and Management, General
1998 — 2000
Virginia Polytechnic Institute and State University
Bachelor's degree, Chemical Engineering
1992 — 1997
Skills
- Chemical Engineering
- Computer System Validation
- Chromatography
- Vaccines
- Filtration
- Corrective and Preventive Action (Capa)
- Management
- Life Sciences
- Technology Transfer
- Cleaning Validation
- Validation
- Project Management
- Biotechnology
- Process Engineering
- Protein Purification
- Standard Operating Procedure (Sop)
- Quality Control
- Gmp
- Quality Assurance
- Lifesciences
- Purification
- Gxp
- Aseptic Processing
- Clinical Trials
- Pharmaceutical Industry
- Sop
- Fda
- Cross-Functional Team Leadership
- Cip
- U.s. Food and Drug Administration (Fda)
- 21 Cfr Part 11
- Biopharmaceuticals
- Cell Culture
- Cgmp
- Aseptic Technique
- Quality System
- V&V
- Manufacturing
- Change Control
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