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About Us
Our consultants have over 30 years of experience each working in engineering roles supporting manufacturing operations for global organizations.
Phil McDuff
Phil is an experienced executive in the BioPharmaceutical industry. With over 30 years of experience, he has led major construction projects, facility start-ups, manufacturing operations, automation deployment, environmental sustainability, and Environmental, Health, and Safety. He has held Engineering and EHS leadership positions at GSK, Biogen, Roche Vitamins Inc., and Sloss Industries Corporation. Phil has expertise in Process Engineering for Biologics Drug Substance, Sterile Drug Product, Small Molecules, Oligonucleotides, and Vaccines. He has experience managing a capital portfolio with over $1.5 billion annual cashflow and was the project director for one of the largest biologics Drug Substance manufacturing facilities in the world, valued at over $1.7 billion. He has been a contributor to ISPE and BPOG guidance for Closed-System operations, which has been instrumental in the advancement of biologics manufacturing. Phil earned his Bachelor of Science in Chemical Engineering from Auburn University and served as a Sergeant in the United States Army Reserve. He currently resides in Clayton, North Carolina.
Gregory Navolio
Greg is an experienced leader with over 30 years of BioPharmaceutical Industry experience, notably with Abbott Labs, Biogen, AstraZeneca, MiliporeSigma, and GSK. He has expertise in areas such as Metrology/Calibration, Engineering, Maintenance, Process Engineering, Utilities, and Automation. Greg has led the design, startup, and qualification of eight GMP manufacturing and laboratory buildings, including two of the largest cell culture manufacturing facilities in the world. He holds a Bachelor of Science degree in Electrical Engineering from the State University of New York and lives in Frederick, Maryland.
Steve Hudd
Steve is an experienced chemical/process engineer with over 40 years experience. Most of his career was working at Biogen, where he led process management for large-scale manufacturing facilities, managed outsourced manufacturing, and developed global infrastructure for engineering projects. He supported Biogen’s Global Manufacturing Operations, including the strategic application of manufacturing technologies and support for external operations. His expertise spans mAbs, Small Molecule, Gene Therapy, Sterile Drug Products, Oligonucleotides, and assembly pack operations. Steve has extensive experience in Process Safety, having performed multiple HAZOPs and PHAs for new and existing operations. Before joining Biogen, he supported large capital projects in various regions, including the EU, Africa, and the US. Steve holds a Bachelor of Science degree in Chemical Engineering from the University of Birmingham, UK, and lives in Cary, North Carolina.
Strategic Concepts Consulting LLC is a premier consulting firm focused on guiding businesses to realize their potential through strategic planning, innovative solutions, and disciplined execution. Our experienced team combines engineering expertise with strong leadership to drive growth and sustainability.
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