Offer Deep Industry Experience
Tunnell is comprised of exceptionally qualified life sciences consultants who not only know the industry inside and out, but who also truly understand your business and what it takes to be successful. Below is just a representative sampling of our industry consultants.
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 I/O. 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.
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.
Susan has over 20 years of life sciences, quality assurance and regulatory compliance experience in the fields of both human and veterinary pharmaceuticals, vaccines, medical devices and biotechnology products. She has developed, implemented and improved quality management systems, laboratories, production processes and supportive enterprise computer systems within R&D and commercial businesses. She is a strategic leader, project / program manager as well as a quality and compliance risk manager.
Prior to joining Tunnell she was a Principal Consultant at PA Consulting Group, where she established processes and procedures for clinical data systems used for capturing and categorizing data for targeted use. She provided training, coaching and reinforcement of the change management framework and principles. Previously she was Global Quality and Compliance Program Director – SAP and Manufacturing Systems at Pfizer (formerly Wyeth Pharmaceuticals). She holds ASQ certifications as a Pharmaceutical GMP Professional (CPGP), Quality Auditor (CQA), Quality Manager/Organizational Excellence (CQM/OE) and Six Sigma Green Belt (SSGB). She is currently pursuing her Masters in Jurisprudence (MSJ) in the field of Pharmaceutical and Medical Device Law at Seton Hall Law School.
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.
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.
Mike Rutledge Ph.D.
Michael Rutledge Ph. D., 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.
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.
Michael E Thomas
Michael Thomas brings over 25 years’ experience to the life sciences industry. He is a highly skilled senior management consultant with global experience and expertise in areas such as applied statistics, Lean Six Sigma, project management and supply chain management.
Prior to joining Tunnell, Mike spent his career with Teva Pharmaceuticals, Merck & Co. Inc., Johnson & Johnson and General Foods Corporation. He has considerable experience supporting Operations, Quality, Research & Development, Technical Services and Supply Chain. Mike specializes in process optimization, process and product robustness, Design of Experiments and Lean Six Sigma.
He is a Certified Master Black Belt, a Certified Quality Engineer, Certified Project Manager, a senior member of American Society for Quality and an adjunct professor.
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.