Tunnell Consultants Offer Deep Industry Experience
Melissa has extensive experience in clinical development from pre-clinical/translational medicine to Phase 1-3 drug development and has been instrumental in facilitating virtual biotech models for early-stage clients. Her consulting services include protocol development and trial design, regulatory services (FDA, EMA and NMPA for pIND/IND submission), translational medicine, pharmacovigilance/safety, clinical operations, data management, and more. Utilizing a virtual biotech model, she has collaborated with early-stage clients to bring novel/first-in-human (FIH) assets to patients globally.
Melissa’s therapeutic experience includes Hematology/Oncology (blood and solid tumors) with modalities such as Small Molecules, Cell Therapies (CAR-T), Gene Therapies (AAV and Lenti), Immuno-Oncology, and Precision Medicine. She has also worked with leading experts in NASH/Liver Fibrosis and CNS therapies.
Contact Melissa at email@example.com
- BBA in Finance and Studies in Life Science Education from MSU
Greg brings to Tunnell over 30 years of experience in the life sciences industry, including over a decade of consulting experience in all business functions. He is adept at strategy development and execution, change management, operations management and program / project management. He is a seasoned operations leader with significant experience in engineering, organizational transformation and supply chain.
Prior to joining Tunnell, he spent 30 years at Merck & Co., most recently as Executive Director, Business Consulting, where he was a program leader in charge of transforming a 2,000 person global regulatory affairs function in order to provide a more competitive advantage for Merck. Previously he was Sr. Director, Merck Sigma Program and Training and MMD Operational Excellence Director where he developed a worldwide Lean Six Sigma Training program that was adopted by over 5,000 employees. He is a Lean Six Sigma Master Black Belt as well as Change Agent II and Process Improvement Master.
Contact Greg at firstname.lastname@example.org.
- MBA, James Madison University
- B.S., Industrial Engineering and Operations Research, Virginia Tech
Stacey Bain, Ph.D.
Stacey is a clinical drug development professional with over 23 years of domestic and global experience in both the biotechnology/pharmaceutical company and CRO settings. Her expertise involves the development and implementation of strategies, processes and procedures for initiating and executing Phase 1 through Phase 3 clinical trials (including early-stage, novel and First-In-Human studies) to maximize efficiency, control costs and minimize timelines through planning and problem solving (complex or simple). Her background includes extensive experience with the evaluation, selection and oversight of third-party vendors. This experience assures a strong foundation of quality and data integrity. She has experience with contributions to multiple types of regulatory submissions (e.g., Briefing Documents, INDs, SPA, Annual Reports, DSURs, EMA Scientific Advice, NDAs, IRs).
Stacey has established highly functional clinical operations teams that planned, initiated and successfully executed clinical trials for clients with novel, First-In-Human characteristics with the potential to become game changing treatments for patients. She has held key senior positions in both the biotechnology/ pharmaceutical and CRO settings as Vice President Clinical Product Development at BioNumerik Pharmaceuticals, Senior Director, Medical Science and Consulting Services at InClin, Vice President Clinical Operations and Consulting Services at Acer Therapeutics, and Vice President of Global Oncology Operations and Consulting Services, WuXi Oncology-Clinical (a subsidiary of WuXi AppTec).
Stacey can be contacted at email@example.com
- Ph.D., Medical Sciences (Pharmacology and Toxicology Department), Texas
- A&M College of Medicine (Texas A&M HSC)
- B.S., Biomedical Science, Texas A&M University
Bill Connell brings over 30 years of experience to Tunnell with both consulting and pharmaceutical operations experience in Life Sciences in the areas of supply chain strategy and optimization, operational excellence and technology solutions such as ERP and product serialization and e-pedigree. His leadership skills and specialized insights have consistently delivered positive results, operational improvements and improved client profitability and performance.
Prior to joining Tunnell in 2019, Bill was President and Managing Director of WD Connell Consulting where he worked with leading pharmaceutical and biotechnology companies on strategy, supply chain optimization, technology solutions and operational excellence. He was also VP, Consulting at Maxiom Group Consulting (which was acquired by Collaborative Consulting LLC), Sr. VP of Global Operations at Iroko Pharmaceuticals/Iroko Cardio LLC where he oversaw the QA, IT, Supply Chain, Tech Ops and Product Development operations, managing over 30 global CMOs and partners. Bill also worked at Tunnell previously as Supply Chain Practice Director and was part of the leadership team during Tunnell’s growth in Life Sciences.
Bill can be reached at firstname.lastname@example.org.
- Lean Six Sigma training, University of Michigan
- MBA, Indiana University of Pennsylvania
- BS, University of Maine
Lisa is a seasoned executive with over 35 years’ experience in bio-manufacturing and cGMP operations, quality, and supply chain for bulk drug and final drug product in all stages of clinical and commercial production. She also has extensive knowledge of operations leadership, lean process improvements, external supplier management, CDMO contract negotiations, business development, sales and marketing and alliance leadership. Lisa previously worked at Tunnell in a Business Development and delivery role.
Before rejoining Tunnell, Lisa was COO at Ridgeback Biotherapeutics, where she was responsible for driving the outsourced manufacturing and supply of ebangaTM for the strategic national stockpile. This included timely responses and delivery on the FDA’s PMCs and PMRs related to the BLA. Previously, she was Vice President, Change Management and Operational Performance at Catalent Cell and Gene Therapy. This position was during the COVID-19 pandemic and the majority of her efforts were related to managing supply chain concerns and inventory. Prior to that Lisa enjoyed over 30 years of diverse experience in operational leadership, process development, analytical support and business development with BioProcess Technology Consultants, Astra Zeneca/MedImmune, Human Genome Sciences (now GSK), Lonza (Portsmouth, NH) and Genetics Institute (now Pfizer).
Lisa can be reached at email@example.com.
- BS, Medical Technology, University of Lowell
- MBA, Northeastern University
Charlotte (Eberle) Hoffman
Charlotte has more than 5 years’ experience as a consultant. Since joining Tunnell in 2018, she has focused her career on the areas of quality and compliance, project and program management, and operational improvements. Charlotte provides services to pharmaceutical and biotechnology clients including, but not limited to, building quality management systems, preparing for client and regulatory inspections, supporting new facility startup and commercialization, and improving overall efficiency through lean processes and continuous improvement.
Charlotte was most recently recognized as a 2021 “One to Watch” by the Consulting Magazine.
She can be reached at firstname.lastname@example.org
- BS, Chemical Engineering, Villanova University
Alex works with our Project Managers and Delivery Executives to execute the strategy and client projects for our Life Sciences business unit. Most recently, as a Facilities & Engineering Fellow at Amgen, Inc., Alex integrated the cross-functional equipment and consumable staging facilities, reducing long-term storage needs by 15% while establishing a standardized and sustainable equipment management scheme. Previously, as Operations & Logistics Manager for the US Navy ROTC at MIT he managed global training logistics for over 100 students in support of active operations on US warships as well as taught Naval Science college courses in Navigation and Naval Operations. Previously, as an Electrical Systems Engineer for the US Navy, Alex led over 30 personnel in the operation and maintenance of site-wide electrical systems and achieved 100% functionality and operational redundancy throughout 7 months of continuous operational deployment. He supervised a 12-person engineering team for propulsion, electrical power, and supporting systems over 800 hours of operation while maintaining consistent system functionality and oversaw engineering system training for over 180 personnel & reduced legacy training shortfalls by more than 50%.
Alex can be reached at email@example.com
- M.S., System Design and Management, Massachusetts Institute of Technology
- B.S., Civil and Environmental Engineering, The Citadel
J. Edgar Guerzon
Edgar is a biopharmaceutical professional with 36+ years’ experience within the Manufacturing and Quality Assurance industries. Most recently he was a biotech and pharmaceutical consultant with Pharma Tech Services in San Juan, PR where he was an independent consultant with major consulting firms for Biotech/Pharmaceutical & Medical Devices. He provided services including FDA Remediation, Compliance, GMP Validation, Project Management & Lean Six Sigma. He authored and executed Validation Protocols (IQ/OQ/PQ), SOPs and reports, Global Policies and Global Procedures and Validation documents (IQ/OQ/PQ, Validation Plan and Comparability protocols) and reports for PAT (Process Analytical Technology). Previously he was Director, Quality Site Head at BluCaribe where he was responsible for the implementation, maintenance and continuous improvement of the Site Quality Systems to ensure the manufacturing of high-quality products, on time, at competitive prices.
Edgar can be reached at firstname.lastname@example.org
- BS in Biology, Ramapo College of New Jersey
Nichole will work with assigned Life Sciences Project Managers and Delivery Executives in executing the strategy and client projects for the Life Sciences business unit.
Most recently she has been a Research Scientist at University of Pennsylvania where she worked on the Chronic Renal Insufficiency Cohort (CRIC) Study. She used data entry to send samples for outpatient testing. She stored and pulled samples and ran testing on them. She has also been a Data Science Student at Springboard and has 550+ hours of hands-on curriculum, with 1:1 industry expert mentor oversight, and completion of 2 in-depth capstone projects. She mastered skills in Python, SQL, data analysis, data visualization, hypothesis testing, and machine learning. Previously, as a Lab Assistant at Quest Diagnostics, she prepared whole blood samples for tuberculosis tests, prepared chemicals for testing, performed maintenance and restocked machinery and used machinery for specimen manipulation.
Nichole can be reached at Nichole.email@example.com
- BS, Ecology and Evolution, University of Pittsburgh
Jonathan brings over 30 years of management consulting expertise to Tunnell, with significant experience assessing, designing, and managing enterprise transformation initiatives, especially to help establish and grow emerging companies. He has significant experience in multiple healthcare sectors, including life sciences and federal health and has published and been quoted in multiple periodicals, and has been a speaker at industry, vendor, and user group conferences and webinars. Jonathan completed LEADERSHIP Philadelphia’s Core Program, which mobilizes private, public sector, and non-profit leaders to enhance their civic knowledge and awareness, enrich leadership skills, and gain non-profit board training and placement. He has since served on the Board of Directors (past Co-Chair) of The Enterprise Center in Philadelphia, whose mission is to cultivate and invest in minority entrepreneurs to inspire working together for economic growth in communities. Jonathan is also passionate about staff mentoring and people development.
Prior to joining Tunnell, he served as a Partner at Infosys Consulting, and a Partner/Principal at Deloitte Consulting. He has held numerous client-facing and internal leadership roles, and his client service activities include: assessing the capabilities needed to grow emerging companies; performing the project/program ROI / business case analyses, project/program evaluation and design, and complex project/program management required to institute those capabilities; enterprise and technology transformation; and operations improvement.
Jonathan can be reached at firstname.lastname@example.org
MBA, Information Systems, New York University, Leonard N. Stern School of Business
BS, Public Policy, Cornell University
Jake is a recent graduate of University of Pittsburgh with a degree in Chemical Engineering. While a Process Engineering Intern at Enpress LLC, in Eastlake, OH, he assisted in designing and implementing cost saving solutions in the production of composite pressure vessels and carbon filtration blocks. He also collaborated with the quality engineering team to create quality specification for R&D carbon blocks. While a student Jake developed and presented a research paper on the production of biofuels in wastewater treatment facilities. Jake will work with our experienced consultants to identify problems and implement solutions while partnering with client leaders and engaging client organizations to significantly transform their business.
Jake can be reached at email@example.com
- BS, Chemical Engineering, University of Pittsburgh
Scott brings a wealth of experience to Tunnell with over 30 years spent in Quality, Operations, functional managerial and wide business leadership in the emerging pharmaceutical, biotech and cell and gene therapy sectors. He is adept at identifying and controlling risks associated with the development and commercialization of new products and is known for his expertise in the interpretation and execution of domestic and international cGMP requirements. Focused on making his clients successful, he has mastered the art of relationship building and ensuring high quality results from both himself and the teams he onboards and indirect teams he mentors and coaches.
Before joining Tunnell, Scott held roles of increasing levels of responsibility at Boehringer Ingelheim, most recently as Executive Director, Compliance and Quality Oversight, where he was the leader for Compliance and Environmental, Health & Safety (EHS) teams and was the program leader for the consent decree program. Previously, he was Executive Director, Launch, where his team ensured high quality, timely and cost effective product launches for the US and Global markets. His experiences in Quality Assurance, Quality Control and Manufacturing and his wide industry network brings numerous benefits to his clients’ business with a positive impact on their culture, leadership development and standardization of processes.
Contact Scott at firstname.lastname@example.org
- Graduate studies, University of Colorado, School of Pharmacy
- BS, Pharmacy, Philadelphia College of Pharmacy and Science
Oyesola will work with assigned Life Sciences Project Managers and Delivery Executives in executing the strategy and client projects for the Life Sciences business unit. Recently, as a Research Associate at First Thought, Oyesola developed a working knowledge of healthcare coverage in competitive landscapes and strategized plans to grow revenue opportunities. She implemented investigative skills to understand the current marketplace and the standards of treatment in the healthcare sector. As a Health Solutions Management Intern at Allscripts she collaborated with their team in Bangalore, India to enhance client usability of ProEHR while gaining exposure to the Agile software development framework. She conducted research pertaining to health care facilities with chronic health management programs and guided clients through process remapping NDC codes to customer medication in ProEHR. As a Lab Assistant in the Neurosurgery Department at Penn Medicine, Oyesola performed cell culturing and media change on rat cortical cells to maturation as well as performed cell imaging on fabricated nanoparticles using florescence microscopy.
Oyesola can be reached at Oyesola.email@example.com
- BA, Biology (concentration in Neurobiology), University of Pennsylvania
Michael Rutledge Ph.D.
Mike Rutledge has extensive experience in quality assurance, quality control, technology transfer, manufacturing scale-up, validation, analytical method development and regulatory filings. His compliance experience includes the evaluation, recommendation and implementation of QA / QC systems for pharmaceutical, diagnostics and bio-analytical operations. He also has extensive experience in the development of APIs, small molecule drugs and biological drugs.
Prior to joining Tunnell, Michael served as Vice President of Pharmaceutical Research & Development for Baker Norton Pharmaceutical Corporation. Previously, he was Director of Pharmaceutical Research & Development for Forest Laboratories, where he directed a staff of professionals whose functions included R&D preformulations, formulations, analytical, clinical supplies, dissolution, stability, organic synthesis process validation and technical transfer for INDs, NDAs and ANDAs. He has also worked as a senior director of technical affairs for Dey Laboratories and in a variety of R&D roles for Rorer Pharmaceuticals. In addition, he has been an assistant professor of pharmaceutics at the University of New Mexico College of Pharmacy and at the University of Tennessee College of Pharmacy.
Contact Mike at firstname.lastname@example.org
- Ph.D., Pharmaceutical Chemistry, University of Florida
- B.S., Pharmacy, University of Florida
- B.S., Chemistry, University of Florida
Clifford J. Sachs
Cliff brings to Tunnell over 35 years of expertise in the fields of Quality Assurance/Quality Systems, CMC Regulatory Documentation and Analytical Research and Development. He is experienced in quality oversight of GMP activities and development of quality management systems, SOPs and documentation standards to assure compliance with US, Canadian and EU GMP regulations for clinical supplies.
Before joining Tunnell Cliff spent 26 years at Bristol-Myers Squibb and attained the level of Associate Director for Quality Assurance/Quality Systems. He provided strategic and tactical guidance to a team of 25 and partnered with senior management to maximize compliance of GMP Operations. He was responsible for the review of analytical data and manufacturing records for internal and contract operations, for managing research specifications and for the management and implementation of enterprise-wide Quality Management Systems. More recently he specialized in Consent Decree and FDA Compliance Remediation at Validant Strategic Consulting.
Cliff can be reached at email@example.com.
- MBA, Pharmaceutical Studies, Fairleigh Dickinson University
- BS, Chemistry, State University of New York