Nick DeMinico

Nick DeMinico

  • I am driven by a passion for collaborative projects that deliver positive outcomes and potentially impact lives in the biopharmaceutical industry. I thrive in environments that foster continuous learning and development, allowing me to hone my skills across diverse processes, cultures, and technical areas. I find fulfillment in mentoring associates and sharing knowledge to empower and build confidence within teams. Witnessing improvements and positive change as a result of my contributions brings me great satisfaction.

  • With over 30 years of experience in the biopharmaceutical industry, I possess a well-rounded skillset encompassing both technical and compliance expertise. My career began in a technical role across all production areas of monoclonal antibody manufacturing. This role instilled a strong foundation in Good Manufacturing Practices (GMP) principles, which I applied to support the successful commercialization of three clinical products. I have extensive experience in establishing processes and systems for reactor operations ranging from 5K to 20K scale during several site start-ups. Furthermore, I have a proven track record of facilitating successful technical transfers to offsite locations, including key Contract Development and Manufacturing Organizations (CDMOs).

    Leveraging my technical knowledge, I transitioned into a Senior Process Technician role, actively participating in complex equipment validations and developing procedures to support clinical and commercial GMP operations. I played a pivotal role in drafting and executing protocols for conducting commercial process validations and supporting characterization studies for BLA (Biologics License Application) submissions.

    After a successful 8-year tenure in production and validation, I shifted my focus to manufacturing compliance. As a liaison between manufacturing and quality, I supported diverse cell culture processes, including the first-of-its-kind "perfusion" reactor at 5K scale. My contributions were instrumental in ensuring the successful technical transfer of lifesaving monoclonal antibodies and proteins, documented according to GMP standards and reviewed by global regulators. Notably, I served as the Lead Compliance for a major vaccine launch, overseeing seamless technical transfers between manufacturing facilities.

    Capitalizing on my expertise, I transitioned into Global Compliance and Quality Project roles for various industry leaders. My responsibilities shifted to conducting audits and assessments, while also contributing to the development of company standards and quality management procedures, including guidances and work instructions. I frequently provided support for pre-approval inspections, remediation of quality systems, and key inspections. In this role, I functioned as a "coach" and document reviewer, ensuring clear and concise presentations for inspectors. Additionally, I pioneered the creation of "storyboards" to facilitate understanding by site subject matter experts during inspections and interactions with regulators.

    • Auditing: I possess a proven ability to lead preparation and conduct audits across various pharmaceutical sectors, including medical devices, combination products

    • Inspection Readiness: I have a proven ability to lead preparation and inspection readiness efforts across various pharmaceutical sectors regulatory jurisdictions (FDA, ANVISA, UK, EU), including medical devices, combination products, pharmaceuticals (non-sterile, biologicals, cell gene therapy), and over-the counter (OTC) products, food and feed, nutraceuticals, and cosmetic manufacturing.

    • Sterile Processing: I offer expertise in all aspects of sterile processing, including execution, shop floor quality practices, and coaching for personnel.

    • SOP/Protocol Development: I have a strong track record of developing clear, concise, and effective Standard Operating Procedures (SOPs) and protocols.

    • GMP Training & Presentations: I am a skilled facilitator, adept at delivering engaging and informative GMP training sessions and presentations.

    • GMP Facilities SME: I am a Subject Matter Expert (SME) in GMP compliance and quality for facilities, providing valuable guidance and support.

    • OTC & Medical Device Expertise: I possess a strong understanding of OTC (Over-The-Counter) regulations and relevant experience with previous medical device certifications.

    • Major Pharmaceutical Site Compliance Lead: During my tenure as Compliance Lead for a major pharmaceutical site, I spearheaded successful outcomes in several key areas. I led the site through multiple regulatory inspections, implemented quality system improvements to streamline product changeovers and cleaning procedures, and optimized raw material sourcing strategies. These initiatives resulted in significant cost savings, increased compliance, and enhanced operational efficiencies. Additionally, I established a sustainable SAP module and supporting procedures.

    • Quality Lead for Facility Start-ups and Transfers: I played a key leadership role in quality for various facility start-ups and transfers, including:

      • The transfer of three monoclonal products from one company to another, with a successful scale-up from 1K to 20K bioreactor processes.

      • Reviewing equipment commissioning documentation, encompassing risk assessments and Factory Acceptance Test/Site Acceptance Test (FAT/SAT) outputs.

    • Global Compliance Partner for Vaccine Manufacturer: I served as a global compliance partner for a major vaccine manufacturer. In this role, I was responsible for approving compliance standard implementation and pre-approval inspections.

  • English

 AFFILIATIONS

CLIENT FEEDBACK

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP