James M. Glover

About James M. Glover

I’m a seasoned pharmaceutical professional that has demonstrated excellent leadership and management in Biologics and Oral Dosage form manufacturing throughout my career. I’m an expert in manufacturing processes and change management in a regulated environment, driving a high degree of competency and excellence in the organizations that I lead. I’ve worn many hats in my career – operator, scientist, supervisor, department manager (manufacturing and QA), project manager, and director, Vice President. As a result, I have a unique ability to manage multi-disciplinary processes/projects and to navigate complex challenges. But the actual experience boils down to the following- I’ve been managing and leading people throughout my career- I have an innate ability to adapt my leadership style to bring out the best in others- I’m the one that organizations have relied on to lead change and improve performance- I’ve improved performance in every organization that I’ve managed - I don’t care who gets the credit. I just want to win- I know what it takes to win- I know the importance of making a commitment and delivering it on time- I love challenges – and creating opportunities from them Specialties:• Operational Excellence / Continuous Improvement• Transforming sites from R&D into Commercial• GMP/ Aseptic Processing and Filling (Vials, Syringes)• CMC, Regulatory Inspections and ANDA/IND filings• Process Validation• Protein Purification (upstream and downstream processing)Playing competitive sports in my earlier years has shaped my work ethic and leadership style. It taught me the importance of- Hard work- Self-discipline- Teamwork and leadership- Always doing your personal best. I have carried this sense of purpose, determination and passion for winning throughout my professional career.

Experience

1. Chief Operating Officer

   Bionova Scientific

   Jan 2023 — Present · US

Education

• UC Santa Barbara

  Biology/Biological Sciences, General

  1989 — 1992

Skills

• U.s. Title 21 Cfr Part 11 Regulation
• Manufacturing
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Budgets
• Quality System
• U.s. Food and Drug Administration (Fda)
• Validation
• Gxp
• Aseptic Processing
• Quality Control
• Gmp
• Management
• Capa
• Corrective and Preventive Action (Capa)
• Leadership
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Change Control