John Zaremba

About John Zaremba

I am a global biopharma manufacturing and engineering executive with deep expertise in biologics, advanced therapies, and sterile drug product operations across clinical and commercial environments. My career has focused on building and scaling manufacturing capabilities, integrating engineering and technical operations, and enabling reliable, compliant supply of complex therapies across international networks.I have led engineering, manufacturing sciences, and technical operations organizations supporting monoclonal antibodies, viral vectors, vaccines, combination products, cell and gene therapies, pharmaceuticals, consumer healthcare, and contract manufacturing. My experience spans facility design and start-up, technology transfer, validation, and lifecycle management, with a consistent emphasis on operational readiness, system reliability, and global standardization. I partner closely with quality, regulatory, supply chain, and commercial leadership to align technical strategy with business growth, accelerate product launches, and sustain performance across sites and contract manufacturers.Throughout my roles, I have directed major capital programs, established global technical functions, and harmonized practices across organizations to improve right-first-time production, compliance, and scalability. I am known for developing high-performing teams, strengthening safety and quality culture, and translating complex technical challenges into practical operational solutions that support long-term manufacturing resilience.Key Skills: Global Biologics Manufacturing | Advanced Therapies | Engineering Leadership | Technology Transfer | GMP Sterile Drug Product | Facility Design and Start-Up | Manufacturing Sciences and Technical Operations | Validation and Qualification | Capital Projects | Global Operations Strategy | Operational Excellence | Continuous Improvement | Regulatory Compliance | Quality Systems | Supply Chain Integration | Cross-Functional Leadership | Organizational Development | Process Optimization | Combination Products | Cell and Gene Therapy

Experience

1. Vice President of Engineering

   FUJIFILM Biotechnologies

   Jun 2025 — Present · College Station, TX, US

   Directed engineering operations supporting biologics and advanced therapy manufacturing, overseeing automation, process engineering, utilities, validation, capital projects, and site services. Collaborated with cross-functional leadership to ensure operational readiness, system reliability, compliance, and harmonization across a global manufacturing network. Directed design, construction, and qualification of a state-of-the-art drug product manufacturing facility, supporting vial, syringe, and cartridge filling with integrated cold chain, accelerating time-to-market for advanced therapies.

Education

• University of Michigan

  Bachelor of Engineering - BE, Chemical Engineering

Skills

• Commercialization
• Process Validation
• Biotechnology
• Process Engineering
• Pharmaceutical Industry
• Fda
• Formulation
• Chemical Engineering
• Change Control
• Process Safety
• Process Development
• R&D
• Supply Chain Management
• Design of Experiments
• Manufacturing
• Operations Management
• Drug Delivery
• V&V
• Process Simulation
• Medical Devices
• Pharmaceuticals
• Six Sigma
• Aseptic Processing
• Verification and Validation (V&V)
• Technology Transfer
• Process Improvement
• Executive Coaching
• Continuous Improvement
• Lean Manufacturing
• Nutraceuticals
• Quality Assurance