Brad Berkowicz
Drug Product Science & Technology Leader
- Role
- Regulatory Specialist (Cder) at FDA
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Brad Berkowicz
MANFACTURING SCIENCE & TECHNOLOGY LEADER Skilled Leader with extensive technical experience in the development, scale-up, technology transfer, validation, launch, optimization, and regulatory filing of drug product manufacturing processes at US and international sites. Proven strength in managing people and leading cross-functional teams tasked with implementing cost-effective strategic initiatives, compliance programs (including Consent Decree remediation), and commercialization of new or transferred products at internal and external (CMO) manufacturing facilities. Exceptional collaboration and interpersonal skills consistently demonstrated in the management of relationships with external suppliers (CMOs). Career highlights include preparing for and working under a Consent Decree until it was lifted, managing relationships with external manufacturing partners, completing development and initial validation of multiple new products, writing Module 3 components of NDAs and post approval supplementary regulatory filings for US and international markets, and designing and implementing a Continued Process Validation (CPV) program across multiple external manufacturing sites. Core competencies: Leadership | People Management & Development | Regulatory & Quality Compliance | Product Development | Process Validation (PPQ)| Continued Process Validation (CPV)| Technology Transfer| Continuous Improvement | Risk Mitigation | External Manufacturing Partnerships | Manufacturing | Technical Services
Experience
Regulatory Specialist (Cder)
Sep 2024 — Present · Philadelphia, PA, US
Education
Lehigh University
MBA, MBA
1999
Purdue University
BS, Chemical Engineering
1988 — 1993
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