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James Ergun
Director Pharmaceutical Development and Manufacturing
Professional Background
James Ergun is an accomplished expert in product and process development, particularly in the realm of manufacturing pharmaceutical products. With a wealth of experience spanning multiple roles in project management, he has consistently demonstrated a profound ability to lead initiatives from conceptualization through to realization, contributing significantly to the realms of scale-up, product transfer, and process validation. His extensive technical knowledge encompasses oral dosage forms, including tablets and capsules, making him a key figure in the pharmaceutical field.
James’s journey has taken him through various prestigious positions, where he has honed his skills in equipment specification and qualification, as well as NDA (New Drug Application) preparation. His expertise is not only technical; he possesses a remarkable aptitude for nurturing teams and fostering collaboration among diverse groups, consistently driving projects to successful completion.
As a Product Development Consultant in his current self-employed capacity, he continues to lend his expertise to organizations seeking to innovate and streamline their processes. Prior to this, he made significant contributions as the Director of Process Development at Adamas Pharmaceuticals, where he implemented strategies that enhanced operational efficiencies and regulatory compliance.
Throughout his career, James has also served as a Pharmaceutical Consultant and held pivotal roles as Director of Product Development at Chem Pharm and Engineering Fellow at Johnson & Johnson. At ALZA Corporation, he was the Sr. Manager of Process Engineering and an Engineering Fellow, where he led various strategic initiatives in process engineering.
Education and Achievements
James holds a Master of Science (M.S.) degree in Chemical Engineering from San Jose State University and a Bachelor of Science (B.S.) degree in Biochemistry from the University of San Francisco. His educational background has provided him with a solid foundation in the principles of engineering and biochemistry, both of which are critical in the field of pharmaceutical development. The combination of his advanced education and hands-on experience across various roles in the industry has positioned him as a knowledgeable resource and a leader in the pharmaceutical sector.
In addition to his formal education, James’s career is marked by a series of achievements that underscore his dedication to pharmaceutical innovation. He has successfully led numerous projects to fruition, ensuring that new drugs are introduced to the market swiftly and efficiently, while maintaining stringent adherence to regulatory standards. His technical challenges have not only inspired him but have also played a crucial role in enhancing the capabilities of the companies he has worked with, optimizing their processes and leading to substantial growth opportunities in the competitive pharmaceutical landscape.
His proficiency in creating processes, protocols, and policies has been instrumental in supporting businesses during rapid growth phases and new drug introductions. This capability speaks to his ability to adapt and innovate in a fast-paced environment, ensuring that all stakeholders are aligned with project goals and timelines.
Achievements
James Ergun has an impressive track record of accomplishments throughout his career in product development and manufacturing. Some of his notable achievements include:
- Successful NDA Preparation: Developed and managed multiple New Drug Application submissions, significantly reducing time to market for pharmaceutical products.
- Leadership in Product Transfer: Spearheaded the seamless transfer of products across various production sites, ensuring operational continuity and efficiency.
- Process Validation Excellence: Led cross-functional teams in validating new manufacturing processes, which facilitated compliance with regulatory standards and improved product quality.
- Enhanced Manufacturing Protocols: Designed and instituted robust protocols for manufacturing processes that have minimized risks while maximizing output.
- Mentorship and Team Development: Successfully guided teams in both technical and interpersonal skills, enhancing overall performance and efficiency within the organizations he served.
- Collaboration with Regulatory Bodies: Effectively collaborated with FDA and other regulatory bodies, ensuring alignment with evolving compliance requirements while achieving project milestones on time.
Overall, James's career reflects his commitment to excellence in pharmaceutical development and his unwavering dedication to overcoming technical challenges. His leadership and specialized skills not only contribute to individual project success but also elevate the capabilities of the organizations he partners with.
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