Brian Jackey
*****.*.******@*****.*** 502-***-****
SUMMARY
Results-driven pharma/biotech operations executive with 30+ years of experience leading manufacturing operations, CMC development, supply chain, and quality for both clinical- and commercial-stage organizations. Experienced CDMO site GM and OSD operations director. Co- founded a clinical-stage biotech organization and played a key role in product acquisitions, licensing, and funding strategies.
CORE COMPETENCIES
• Pharma/Biotech Manufacturing & Executive Leadership
• CDMO Site General Management
• Quality, Supply Chain & CMC Development Leadership
• Broad Expertise in OSD, Steriles, Biologics, and Devices PROFESSIONAL EXPERIENCE
EVP, Operations
Arnasi Group (formerly LiquiGlide, Inc) – Cambridge, MA Jul 2023 – Apr 2025
• Led Regulatory Affairs, QA, Supply Chain, HR, Finance, and CMC teams.
• Achieved FDA and Class I medical device registration for ostomy product (Revel).
• Established new manufacturing facility and initiated construction.
• Reduced cost by $1.9M annually through optimized facility transition. SVP, Technical Operations (Co-Founder)
Aceragen, Inc. – Raleigh, NC Apr 2021 – Jun 2023
• Built and led RA, QA, SC, and CMC Development teams from scratch.
• Resolved complex rhAC biologics manufacturing challenges and led mitigation that lifted the FDA clinical hold.
• Enabled Farber Disease clinical trials with optimized CTM production.
• Led diligence, funding, and licensing negotiations. VP, Manufacturing Operations
Graybug Vision – Baltimore, MD Aug 2020 – Apr 2021
• Oversaw construction and qualification of in-house GMP facility.
• Managed CDMO to support GB-102 for Phase 3 trials.
• Prepared for future commercial-scale production. VP, Global Operations and Quality
US WorldMeds – Louisville, KY Apr 2015 – Aug 2020
• Led SC, QA, CMC development, and commercial manufacturing for 8 products.
• Directed CDMO operations and tech transfers across multiple modalities.
• Negotiated 30+ supply and development contracts.
• Reduced COGs by 40% and closed biologics site saving $10M annually. Sr. Director, NA Operations (Site GM)
Aptalis Pharma – Vandalia, OH Apr 2014 – Apr 2015
• Oversaw two CDMO sites with full operational responsibility.
• Implemented OpEx programs across functions and completed $20M site expansion.
• Drove customer service and P&L performance during ownership transition. Director, Plant Operations (and prior leadership roles) UCB Pharma (formerly Schwarz Pharma) – Seymour, IN 1993 – 2014
• Led all manufacturing at 3B+ dosage OSD plant with 300+ staff.
• Implemented advanced OSD technology platforms.
• Directed 20+ product launches, site expansions, and 25+ audits.
• Increased in-stock rates to >99% across 100+ SKUs. Sr. Process Engineer
Bristol-Myers Squibb – Evansville, IN 1992 – 1993
• Led product site transfers and supported tablet/capsule operations. KEY ACCOMPLISHMENTS
• Medical Device: Enabled launch of Class I device via FDA and site registration.
• CMC Development – Biologics: Scaled rhAC enzyme, lifted FDA hold, and enabled FIH study.
• Commercial Supply: Delivered 100% service levels and reduced COGs by 40%.
• CDMO GM: Exceeded performance during ownership changes.
• Generics Launches: Led 15+ generics launches supporting $1.4B business sale.
• Site Expansion: 4x GMP space, 10x capacity, and headcount growth from 200 to 600.
• OSD Tech Transformation: Modernized processes with advanced automation. EDUCATION
BS, Chemical Engineering – Rose-Hulman Institute of Technology, Terre Haute, IN