Broad-based Knowledge Focused on Process Optimization and Operations Efficiency 

I am Cheryl Smith, Principal Consultant at bioTsys Consulting. I look forward to helping you overcome bogged down processes, lack of adequate resources and limited operational leadership acumen. bioTsys Consulting provides facilities, manufacturing, operations, and technical writing consultation services to companies in biotech, life sciences and medical device/diagnostics industries. 

Consultation involvement ranges from providing temporary management for companies which need to establish an operational foundation to companies which have outgrown their current processes and policies due to successful growth and need optimized solutions. You will receive assistance and tangible deliverables centered around streamlining processes, reduction of cost of goods, eliminating process gaps and unambiguous technical documentation.

I bring a unique blend of lab and facility operations strategic planning and over 15 years of experience in process optimization to increase efficiency utilizing innovative solutions. My approach is based on industry standards (CLIA, ISO13485, 5S, Six Sigma, cGMP) as well as depth of experience in product manufacturing, assay development and optimization, data processing and analysis, lab startup, facility expansion, documentation creation and management, customer training and regulatory compliance. I have extensive experience managing cross-functional team projects and scheduling tasks to ensure maximization of resources and stakeholder involvement.

bioTsys Consulting services integrate well into existing client teams and is ultimately invested in the success of your company by providing scalable solutions.

I have 15+ years of experience in operations, facility and asset management, manufacturing, product development and commercialization, regulatory and EH&S compliance as well as front of house administrative tasks. I have maintained  daily operations in start-ups and large global companies, implemented systems, optimized processes, managed documentation and manufacturing activities. I have successfully led team projects ranging from lab planning, manufacturing optimization to company acquisition integrations. My educational background in Molecular Biology allows me to understand how technology relates to operations and strategically plan mutually beneficial solutions.

I began my  career in the lab and was quickly promoted to management and operations director because of my work ethic and creative problem solving. Soon after, I recognized a need for multi-faceted consultants with broad based knowledge of industry standards (CLIA, ISO13485, 5S, Six Sigma, cGMP) combined with the directness and focus to bridge the gap between identifying and implementing valuable process optimization. I have always been interested in leading projects that will have a significant impact on the company whether associated with cost savings, identification of process failures or revision of outdated documentation.  I enjoy dissecting systems into basic procedures and then optimizing to be more efficient which fueled my decision to become a consultant.

The bioTsys Consulting logo highlights what proficiency customers can expect from my services:

• DNA (foundation) - Molecular Biology education and working in the lab established and honed my research and documentation skills.

• Gear (action) – Utilizing a hands-on approach coupled with the unique ability to balance feedback from lab personnel and management, I provide innovative and valuable implementation plans.

• Lightbulb (troubleshooting) – Throughout my career, I was tasked with managing the most difficult projects with great success.

• ƞ (efficiency) – Leveraging my experience in the lab as well as operations gives me the unique ability to quickly assess gaps, develop plans and implement necessary changes to increase productivity.