Tunnell Consultants Offer Deep Industry Experience
Kati is a seasoned regulatory affairs professional with over 30 years’ experience in the Life Sciences and a strong multifunctional regulatory, quality and technical background. Her regulatory experience spans pre-IND through BLA submissions to life cycle management, forging pathways for new technology products, sustaining product supply and developing a viable regulatory compliance infrastructure for clinical sample testing laboratories. She has extensive experience in cross-functional teams to develop, negotiate and implement regulatory strategy in alignment with the regulations and business goals, with significant experience and successful interaction, both formal and informal, with the FDA and other regulatory authorities.
Prior to joining Tunnell, Kati worked in the biopharmaceutical industry both in biotech and in big biopharma. At VaxInnate Corporation, she was VP, Regulatory Affairs with responsibilities for development and execution of regulatory strategy for the products at all stages of development as well as for managing QA and support for the company’s contracts and partnerships. At Merck & Co, Inc., Kati held roles with increasing responsibility in the vaccine analytical laboratories, QC, CMC regulatory, regulatory compliance management for vaccine clinical testing and regulatory affairs international for immuno-oncology. While at GSK, she worked in North American Regulatory Affairs, supporting licensed and in development flu vaccines, including adjuvanted, cell culture-based and pandemic indication products, and she filed the first adjuvanted pandemic indication avian flu vaccine in the US. Kati’s first position in industry was in R&D at Centocor (now Janssen Biotech). Kati started her career at Children’s Hospital of Philadelphia where she worked in infectious diseases and cancer research.
Contact Kati at email@example.com
- BS, Medical Technology, University of Pennsylvania
- Medical Virology Graduate Work, St. Thomas Hospital Medical School, London
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
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 email@example.com.
- Lean Six Sigma training, University of Michigan
- MBA, Indiana University of Pennsylvania
- BS, University of Maine
Before joining Tunnell Charlotte was a consultant in the Disputes, Forensics and Legal Technology – Global Construction Practice at Navigant Consulting where she earned the distinction of being the most utilized consultant from the Associate Director level and below. Her responsibilities included conducting large data asset analyses including damage quantifications, schedule delay/acceleration analyses, contract, and accounting record audits and risk and compliance assessments. While providing Regulatory Support to a large biotechnology plant she performed in-depth forensic and regulatory analysis of opposing sides’ alleged claims in manpower, escalation, loss of productivity and inflated bond and insurance rates. Findings were used in litigation support presentations. Previously Charlotte was a Research Fellow at Villanova University.
She can be reached at Charlotte.Eberle@tunnellconsulting.com
- BS, Chemical Engineering, Villanova University
Scott has more than 25 years of experience in the areas of technical, managerial and business leadership in the global pharmaceutical industry. He has a proven and successful track record of delivering cost effective, timely results in highly complex and fast-paced environments serving global markets. He is adept at identifying and controlling risks associated with development and commercialization of pharmaceuticals. Scott is known for his expertise in the interpretation and execution of domestic and international cGMP requirements.
Prior to joining Tunnell, he was Executive Director, Compliance and Quality Oversight at Ben Venue Laboratories, Inc. Scott was responsible for setting the company’s strategy for the interpretation, auditing and execution of those requirements. He led the Compliance and Environmental, Health & Safety (EHS) teams and managed the site-wide Consent Decree Remediation Program. Previously he was Executive Director, Launch at Boehringer Ingelheim Roxane, Inc., where he ensured high quality, timely and cost effective introductions of innovator and multi-source products meeting the requirements of FDA, EMA and ROW authorities.
Contact Scott at firstname.lastname@example.org
- Graduate studies, University of Colorado, School of Pharmacy
- BS, Pharmacy, Philadelphia College of Pharmacy and Science
Julia C. O'Neill
Julia is a CMC Statistician with over 30 years of experience bridging statistics and chemical engineering, applied to a broad range of challenges in vaccines, biologics, pharmaceutical and chemical development and manufacturing.
Prior to joining Tunnell, Julia was Director, Engineering, Global Technical Operations at Merck and Co. where she was responsible for development and deployment of process robustness strategy for manufacturing . Her team designed and installed Continued Process Verification for vaccines and biologics, and supported CPV for all human health products. Previous positions include Senior Scientific Fellow – Statistics in Regulatory & Analytical Sciences at Merck; Director, Engineering, Vaccines and Biologics Technical Operations at Merck; and Powder Coatings Process Development Leader at Rohm and Haas Co. Julia is a Master Black Belt and expert in resolving challenging problems using statistical, engineering and Six Sigma methods.
- MS, Statistics, University of Wisconsin
- BS, Chemical Engineering, University of Maine
N. Zachary Rausch
Zach is a 2019 graduate of University of Maryland, College Park where he earned a BS in Bioengineering. While at UMD, Zach received the Phi Kappa Psi Men of Excellence Scholarship Award. At Human Performance Research Laboratory he was a Principal Investigator and utilized an Air Perturbation Device to test possible diurnal respiratory effects on adults. As a student in Bioproduction and Biotechnology he executed bacterial cell inoculation, cell banking and stirred-tach batch production at lab and pilot scale (1-10L). He was the Team Co-Leader on a Capstone Design Project where he partnered with clinical mentors from Children’s National Hospital and the Bioengineering Department at UMD to design and devise a new device and method.
Zach can be reached at email@example.com
- B.S., Bioengineering, University of Maryland, College Park
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
Anna M. Ward
Ana comes to Tunnell from Veri Nano in Boston, MA where she was a Business Development Associate. She assisted the cofounders with the pre-launch and scaling of a nanotechnology-based skincare startup based out of Harvard Medical School and MIT. She assisted in the development and implementation of business strategy and communicated marketing research to the R&D team.
Simultaneously, she was also a Research Analyst Intern at InvestmentBank.com, Healthcare Division, where she assisted the managing editor with a capital raise and buy-side mandates and analyzed and reported on industry transactions, cost structure benchmarks and external drivers. She was also a consultant at National Science Foundation, I-Corps Fellowship Program and a Digital Marketing Member at Nomad Dairy.
Ana can be reached at firstname.lastname@example.org
- M.S. in Biotechnology and MBA with a specialization in Healthcare Management, Brandeis University
- B.S. in Plant Sciences, University of Florida
Kip brings to Tunnell more than 25 years of experience as a management consultant, during which he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Kip has temporarily worked inside the life sciences industry on two occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and, at Merck, in the research and development division. In January 2015 Kip joined Tunnell Consulting where he brings his product development program management experience to bear to improve the probability of successful regulatory filing and product launch. He also leads the data integrity practice at Tunnell and consults, teaches, speaks and publishes regularly on topics of data integrity and quality systems.
His technical experience includes the fields of quality assurance and regulatory affairs, GMP and IT compliance, technical operations and product supply. His areas of expertise include business transformation, new business development, organizational change leadership and program / project management. Kip holds and maintains various credentials, including the Project Management Professional (PMP) credential and the Program Management Professional (PgMP) credential. He has also completed graduate studies in Drug Development at Temple University, and holds multiple business degrees from Eastern University: an MBA in Management and an undergraduate degree in Management of Information Systems.
Contact Kip at email@example.com.
- MBA, Management, Eastern University
- Graduate Studies, Drug Development, Temple University
- BA, Management of Information Systems, Eastern University