My qualifications center on a depth of forward-thinking experience in the biotechnology industry. I have led global design efforts focused on the manufacture of human therapeutic drugs, both in drug substance and drug product development and manufacturing programs. Many of these projects involved multi-product manufacturing platforms and include small and large-scale production of large molecule products, and new advanced platforms in the ATMP space in Cell and Gene Therapy for both mainstream and CDMO organizations. I have published over 50 peer-reviewed articles on subjects including advanced manufacturing platforms, risk assessment and mitigation, and program management execution to comply with changing global GMP regulations. My qualifications as a recognized SME have also led to the publication of four industry reference books and being part of the Teams developing industry guidance documents such as the ISPE Baseline Guides and Good Practice Guides. I was co-Lead for the development of the 3rd edition of the Biomanufacturing Facilities Baseline Guide, published in November, 2023. I am a Teaching Fellow in the graduate school for Biomanufacturing at NC State’s BTEC.
Providing thought leadership to develop and lead strategic manufacturing initiatives for Clients such as BMS, BioNTech, Moderna, Lonza, and Catalent in the Biomanufacturing Industry. This includes providing strategic planning, feasibility assessment, compliance review, design review, risk assessment and mitigation strategy development, cost and schedule analysis, and program management services to a wide range of companies in the ATMP and Biotech Industries. Providing consulting services for Clients seeking FDA and EU approval of manufacturing facilities, conducting facility risk assessments and CCS development, and delivering technical training in topics related to design, operations, compliance and project management, including FDA and EU Annex 1 guidance is part of the position role. Also developed the business plan, strategic growth plan, and execution strategy for a Biomanufacturing/Life Science Business Unit of a global services firm. Strategic role tasked with the identification of resources, development of internal training tools and project execution planning, budget development, establishment of procedures to comply with global regulatory guidance, and the creation of an execution strategy to establish the foundation for growth in the Life Science industry.
On August 25th, 2023, the long-awaited revision to Annex 1 became effective. The updated Annex 1 introduced a number of significant regulatory changes, including a greater emphasis on quality risk management (QRM), detailed requirements for barrier technology, and a widened regulatory scope to cover sterile products. One of the most significant changes was the requirement for a documented Contamination Control Strategy (CCS) that should be implemented across an entire facility. The CCS should unify disparate contamination controls into a unified framework in alignment with US FDA and PIC/S regulations and guidance documents issued by ISPE, PDA, and ICH. According to Annex 1, the CCS is referred to as a family of documents that unite, evaluate, and record the adequacy of tools used to assure the purity and quality of drug products. The heightened focus on the CCS is centered around not only physical mechanisms to control both intrinsic and extrinsic contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. Development of sound, compliant CCS efforts has been a focus of our work since 2023.
I am an internationally recognized SME, speaker, author, and professional training instructor. My background includes providing university lectures, classroom instruction, and professional development training in the areas of regulatory compliance, facility design and qualification, validation, risk assessment, and project management in the United States and twenty foreign countries. These professional training efforts have included not only numerous sponsored sessions throughout the globe, but custom training for many of the global pharma/bio companies such as Abbott, Astra Zeneca, Glaxo Smith Kline, Merck, Merial, Novartis, Eli Lilly, and IBM. I have also participated in and led training sessions for regulators from the United States, Canada, Thailand, Japan, and Mexico. Courses that have been developed and delivered include:
A career of over 30 years has focused on the development, execution, delivery, and management of operational programs in the Biomanufacturing Industry. Working globally with both operating companies and service providers, it has resulted in key roles leading Teams in the execution of project efforts that ranged in size from $1 million to more than $2 billion in total program costs. These involved some of the largest “blockbuster” drug programs and include both mainstream manufacturing and CDMO organizational support.
Managed Global Subject Matter Experts and resources in four countries tasked with supporting project planning, technical and business feasibility, design, and manufacturing initiatives and programs, and operational program assessment for ten biologics manufacturing sites within the global Sanofi Biologics network. Project portfolio value at €450 million. Included IND support, CMO liaison, technology transfer, risk assessment, master planning and assessment, feasibility assessment, project controls, project delivery, clinical manufacturing support, and product launch support. The product portfolio included 12 new INDs and the launch of Dupixent®, and also involved additional product launches in six different countries.
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