About

Macro Scope BioConsulting is a scientific and strategic consulting firm specializing in pharmaceutical Quality Control (QC), microbiology, and rapid analytical technologies for the pharmaceutical, biotechnology, and life sciences industries.  We partner with pharmaceutical manufacturers, technology suppliers, and service providers to develop innovative solutions that improve product quality, accelerate technology adoption, and advance the future of pharmaceutical quality control.

Our core expertise encompasses pharmaceutical microbiology, including bioburden, sterility testing, environmental monitoring, microbial identification, contamination control, and microbial risk assessment, with particular emphasis on the evaluation, implementation, validation, and optimization of rapid microbiological methods (RMMs). By combining extensive experience with both traditional compendial methods and emerging rapid technologies, we help organizations modernize Quality Control laboratories, reduce time-to-result, improve operational efficiency, and support science- and risk-based decision making while meeting global regulatory expectations.

Beyond technical consulting, Macro Scope BioConsulting serves as a trusted scientific advisor to technology developers and suppliers supporting the pharmaceutical and life science industries.  We help organizations identify unmet customer needs, define market opportunities, and shape product development strategies through Voice of Customer (VoC) research, key opinion leader (KOL) identification and engagement, competitive landscape assessments, and scientific advisory support.  From concept through commercialization, we provide strategic guidance to ensure new products and technologies align with customer requirements, market expectations, and evolving industry regulations.

Our consulting philosophy is grounded in taking a holistic, big-picture approach. Rather than focusing on individual technologies or isolated laboratory challenges, we evaluate the entire pharmaceutical quality ecosystem—including manufacturing workflows, regulatory expectations, operational efficiencies, technology readiness, customer needs, and business objectives. This systems-level perspective enables clients to make informed decisions that deliver long-term scientific, operational, and commercial value.

Macro Scope BioConsulting also provides strategic guidance across pharmaceutical Quality Control programs, supporting analytical and microbiological technology assessments, laboratory modernization, quality systems, testing strategy development, regulatory readiness, and implementation planning. We work collaboratively with clients to identify fit-for-purpose technologies, optimize testing workflows, and develop practical solutions that align scientific innovation with manufacturing and business goals.

Our expertise spans small-molecule pharmaceuticals, biologics, monoclonal antibodies, vaccines, cell and gene therapies, contract development and manufacturing organizations (CDMOs), contract testing laboratories, and manufacturers in the food, beverage, dairy, and home & personal care industries. This diverse experience allows us to apply cross-industry best practices while recognizing the unique technical, operational, regulatory, and commercial challenges facing each client.

At Macro Scope BioConsulting, we are committed to helping organizations transform pharmaceutical quality through scientific expertise, strategic insight, and practical execution. By integrating deep knowledge of pharmaceutical microbiology, Quality Control, rapid microbiological technologies, customer engagement, and commercialization strategy, we empower our clients to confidently navigate evolving regulatory expectations, develop innovative products that solve meaningful customer challenges, and achieve lasting business success.

Lori has over 30 years’ of experience in clinical, environmental, and industrial microbiology.  She is a technical expert on rapid and alternative microbiological methods and is an active member of the Parenteral Drug Association (PDA), the Association for the Advancement of Blood & Biotherapies (AABB), the International Society of Blood Transfusion (ISBT), and the International Society for Cell & Gene Therapy (ISCT).

Lori previously worked at Bionique Testing Laboratories LLC as their Chief Scientific Officer, where she helped advance scientific strategy, strengthen quality systems, evaluate emerging microbiological technologies, and support the adoption of both traditional and rapid sterility testing approaches.  Before joining Bionique, Lori was at bioMérieux as their Sr Director of Scientific Affairs, providing support to the Pharma Quality Control business. While at bioMérieux, Lori identified and implemented improved detection of mold and Cutibacterium acnes for the  BACT/ALERT® 3D Microbial Detection System. She excelled at engaging with customers, understanding their needs, and assisting with technical issues. She authored numerous technical whitepapers, presented at several conferences, and recorded webinars on microbiological solutions for the biopharmaceutical industry. She has presented to both the FDA’s Center for Biological Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) as part of the FDA’s Emerging Technology Program and Compounding Quality Center of Excellence, respectively.

Before joining bioMérieux, Lori worked for 11 years at Celsis, a leading rapid microbiological method supplier utilizing ATP bioluminescence, in a variety of technical roles,  including VP of Scientific Affairs and Reagent Development. While at Celsis, she created and implemented a global technical management program with standardized SOPs, training material, account management, application laboratory support, and customer technical reports. She was the key technical resource for R&D, product management, and marketing, and helped analyze and lead their next-generation rapid method using a concentrating pipettor and hollow-fiber tips with Celsis AMPiScreen reagent technology.

Lori received her PhD from the University of Minnesota in Microbial Ecology studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on phytoremediation of polyaromatic hydrocarbons and the use of earthworm egg capsules as a mechanism to disperse beneficial microorganisms, and at the Los Alamos National Laboratory using molecular tools to study microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.