TUNNELL CONSULTING - Key Persons
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 alex.goodwin@tunnellconsulting.com
EDUCATION
M.S., System Design and Management, Massachusetts Institute of Technology
B.S., Civil and Environmental Engineering, The Citadel
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, 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 QA, IT, Supply Chain, Procurement, CMO RFP selection and management, Graphics/Artwork, Packaging/Labeling, Technical Operations and Product Development. He selected and managed over 30 global CDMOs, CMOs and partners. Bill also worked at Tunnell previously as Supply Chain Practice Director for ten years and was part of the leadership team during Tunnell's growth in life sciences.
Bill can be reached at bill.connell@tunnellconsulting.com.
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 charlotte.hoffman@tunnellconsulting.com
EDUCATION
BS, Chemical Engineering, Villanova University
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.
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 edgar.guerzon@tunnellconsulting.com
EDUCATION
BS in Biology, Ramapo College of New Jersey
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 jake.johanni@tunnellconsulting.com
EDUCATION
BS, Chemical Engineering, University of Pittsburgh
Job Titles:
- Senior Vice President, Tunnell Government Services
- Tunnell 's Senior Vice President for Government Services
Tunnell's Senior Vice President for Government Services, Jerry Robinson, has more than 30 years of experience in government contracting, including experience with scientific services, technologies, software and solutions ranging from innovative C4ISR and advanced sustainment systems to counterterrorism, intelligence and integrated security solutions for clients in the defense, intelligence and homeland security communities. To his work with Tunnell's government clients he also brings a strong background in finance and accounting that is invaluable for agencies that must do more with less in an age of tightening budgets.
Formerly Chairman and CEO of SFA, Inc., a subsidiary of then Global Technology Strategies, Inc., a national security company, he has a deep understanding of the needs of government agencies and an extensive track record of working with them successfully. His prior experience also includes serving as Chief Financial Officer of SFA, Inc. In addition, he has held key finance positions at Vega Precision Laboratories, a defense electronics manufacturing company; Halifax Engineering, a government contracting IT and security service company; and Fairchild Industries.
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 jonathan.horn@tunnellconsulting.com
EDUCATION
MBA, Information Systems, New York University, Leonard N. Stern School of Business
BS, Public Policy, Cornell University
Larry brings to Tunnell over 30 years of experience in the financial services industry. As Chief Financial Officer he maximizes financial results and improves operations. He helps the organization craft sound business solutions that serve both our future and the well-being of our client companies. He is responsible for evaluating the impact of long-range planning, evaluation of potential alliances, acquisitions or mergers, pension plans, investments and various benefit plans of the corporation.
Prior to joining Tunnell Larry was Controller/Chief Financial Officer of Marcum LLP (formerly Smart Devine LLC) where he oversaw all financial activities for a small regional accounting, tax and consulting firm. He was the primary contact for banks, lawyers, outside accountants and insurance companies. He successfully managed due diligence processes and was responsible for the due diligence process related to the conversion of the company. Previously he was CFO at Magellan Search and Staffing and Vice President, Finance, Yoh Services, LLC at Day & Zimmerman. Other positions included VP/CFO at CDI Corporation and CFO for the Financial Services Line of Business at KPMG LLP. He is also a CPA.
Job Titles:
- Chief of Staff
- Vice President
- Member of Tunnell 's Board of Directors
Marian has been with Tunnell for over 40 years and has held roles that include Vice President, Business Operations and Employee Retention with Tunnell Government Services, Director of Human Resources, HR Business Partner and Assistant to the President.
She has extensive knowledge of Tunnell's culture and clients. As a co-leader in the strategic planning process, she provides the strategy team with the necessary resources to ensure alignment with the CEO and leadership team. She assists in Tunnell's succession planning process with the goal of preparing the firm for its continued success in the future.
Marian has been a member of Tunnell's Board of Directors as Corporate Secretary for over 20 years. In conjunction with Tunnell's Finance department she oversees the Tunnell-sponsored ESOP and 401k retirement plans.
Maryann is an experienced consultant with over 25 years of experience with a focus on Life Sciences. Maryann has split her time working in both Europe and North America helping clients with business strategy and organizational transformation. Her consulting assignments have provided her with opportunities to work across businesses in Research and Development, Supply Chain, Sales and Marketing as well as in Support Services.
Maryann has held a variety of leadership roles with Gemini Consulting, Capgemini, The Monitor Group and Archstone Consulting. Prior to beginning her consulting career, Maryann spent eight years in public accounting with Arthur Andersen & Co. where she earned her CPA. She has been a member of Tunnell's Board since 2014.
EDUCATION
Graduate Certificate, Women in Politics and Public Policy, University of Massachusetts
MBA, Trinity College, Dublin, Ireland
BS, Business Administration, Boston College
Certified Public Accountant
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.
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.
Job Titles:
- Group Vice President, Business Development Leader, Life Sciences
Over the last 30 years, Bob Johnson has led and advised multinational companies and helped them achieve record sales and profits through the implementation of business development and operational excellence programs. He has worked with global organizations, turn-arounds, startup companies and private equity firms, and for the past 10 years has focused on pharmaceutical, biotech and medical device organizations.
His areas of expertise include sales process improvement, operational strategy, lean manufacturing, performance and compliance improvement, organizational effectiveness, change management and strategic outsourcing. In the course of his career, he has held key roles at a number of leading consulting companies, including Celerant, Sapient and EDS. He has also held a variety of roles with high tech, systems integration and computer consulting companies, including Ampro, Data General and Wang Laboratories.
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.
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 stacey.bain@tunnellconsulting.com
EDUCATION
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