Edwin Roman

About Edwin Roman

Summary of QualificationsOver 20 years of experience in the Chemical, Pharmaceutical and Biotechnology industry in PR and US. Experience in manufacturing and analytical laboratory processes for Sterile & Aseptic, Liquids/Solutions and Solid Dosage Forms. Proven track record for implementing lean manufacturing and continuous improvement strategies that enhanced productivity and profitability. Highly focus onto provide leadership, management and technical skills. Ability to work in multi-function environment and adapt to changes. Highly responsible and self-motivated, teamwork believer and results oriented. Knowledge in cGMPs, cGLPs OSHA, DEA, and FDA regulations. Highly flexible towards business needs.Achievements• Successful \"start-up\" for an API Biotechnology mfg process as a Manufacturing Manager• Recruit, train and develop talent for the transfer of new a manufacturing technology• Introduce and structured a new system for ideas management and Lean Manufacturing (OPEX)• Key cultural transformation agent for the continues improvements by implementing SQPID• Develop and implement strategies to increase run rates for manufacturing of API batches• Implement the “On-the-floor” batch record review team with a 24-hour record review • Introduce and implement (ESMR) the Environmental and Safety Program for a production team • Key contributor on Downstream-Protein Purification improvements to Achieve Corporate Best Plant Award• Increase 10% yields in 3 months by re-evaluating training program of a specific aseptic operation resulting in 200K more units per month• Implement 5S for a specific operation unit resulting in more space and avoidance 10% of scrap material• Reduce safety incidents by 80% by modifying SOP\'s and improving training materials for a specific unit operation• Establish a production structure of 24/7 to respond business demand for a specific brand name product

Experience

1. Head of Manufacturing, Operations Director

   Veranova

   Jan 2026 — Present · NJ, US

   Directed operations and process engineering in API manufacturing at Veranova, ensuring best-in-class manufacturing practices. • Championed the implementation of a Continuous Improvement culture to enhance operational efficiency. • Focused on staff development as a key goal, fostering a skilled and motivated workforce.

Education

• Universidad de Puerto Rico

  BS, Industrial Chemistry

  1991 — 1996

• Massachusetts Institute of Technology

  Downstream Processing , Protein Purification Large Scale

  2006 — 2006

• University of Maryland Global Campus

  Master of Science - MS, Biotechnology

  2018 — 2022

Skills

• Fda Gmp
• Lims
• Aseptic Technique
• Computer System Validation
• Quality System
• V&V
• Process Simulation
• People Development
• 21 Cfr Part 11
• Analytical Chemistry
• Analitical
• Biopharmaceuticals
• Manufacturing
• Elisa
• Capa
• Quality Control
• Gmp
• High Organizational Skills
• Formulation
• Validation
• Process Improvement
• Fermentation
• Pharmaceutical Industry
• Sop
• Fda
• Contract Manufacturing
• Microbiology
• R&D
• Downstream Processing
• Iso 13485
• Uv/Vis
• Chromatography
• Cell Culture
• Change Control
• Biotechnology
• Protein Purification
• Trackwise
• Regulatory Requirements
• Sterilization
• Regulatory Affairs