DOUG CLARK

Doug Clark is a seasoned managerial leader with a diverse background and extensive experience in pharmaceutical, med device, food/beverage, materials, metal, plastics, silicon, and packaging/cold chain industries.

He excels in coaching, challenging the status quo, and leading high-performance teams using Lean principles and employee relations best practices.

With expertise in GxP systems and contract manufacturing, Doug ensures the maintenance of a robust Quality Management System (QMS) that complies with industry regulations.

His specialization includes biopharmaceutical contract manufacturing, quality processes, mammalian cell culture, cGMP requirements, and start-up of new manufacturing plants.

Doug is well-versed in regulatory frameworks such as 21 CFR Part 210 & 211, 820, ISO 13485, ISO 9001:2015, ISO 17025, and AS9100, demonstrating a comprehensive understanding of quality management practices.

He is skilled in managing quality systems, driving continuous improvement, optimizing processes, and overseeing contract manufacturing suppliers to ensure customer satisfaction and product excellence.

Doug's leadership extends to business growth, plant expansion, staffing strategies, and performance management, backed by certifications in Six Sigma and Lean principles.

His technical proficiency encompasses thermoforming, injection molding, clinical packaging, silicone overmolding, single-use technology, and FDA-approved biologics, showcasing a strong background in critical components manufacturing.

In addition, Doug has experience in regenerative drug products, quality testing labs, ISO and FDA audits, sterile products, cleanroom operations, and 3rd party supplier management.

Doug Clark's educational background includes a Bachelor of Science (BS) from Indiana Institute of Technology, specialized studies in batch culture of recombinant tPA-secreting CHO cells, and certifications in Green Belt Six Sigma from Villanova University.

He has held key positions in organizations like Saint-Gobain in quality management and has a technical background in biopharmaceutical companies.