Tunnell Consultants 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.

Consultants Page

Consultants

Katalin Abraham
BACKGROUND AND EXPERTISE

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.

 

Contact Kati at katalin.abraham@tunnellconsulting.com

EDUCATION
  • BS, Medical Technology, University of Pennsylvania
  • Medical Virology Graduate Work, St. Thomas Hospital Medical School, London
Ramon Abreu
BACKGROUND AND EXPERTISE

Ramon Abreu has nearly 40 years of experience in the pharmaceutical industry, including extensive experience in product development, technology transfer, process validation and manufacturing operations. A member of the Tunnell team for more than 15 years, he provides consulting, technical and managerial support for development, technology transfer, validation, product launch, manufacturing processes and operations and quality assurance. In addition, he is adept at designing and managing projects as well as building consensus and partnering with cross-functional peer groups and management business partners to achieve operational improvement.

 

Prior to joining Tunnell, he worked in a broad range of manufacturing and science roles. He was a facility manager at Andrx Pharmaceuticals. Prior to that he was a plant manager at Pralex Corporation, a senior pharmaceutical scientist at Schering-Plough Products, and a manufacturing supervisor at Baker Norton Pharmaceuticals and SmithKline and French Laboratories (now GlaxoSmithKline).

 

Contact Ramon at ramon.abreu@tunnellconsulting.com

EDUCATION
  • B.S., Social Sciences, University of Puerto Rico
  • Associate Degree, Chemistry, University of Puerto Rico
Greg Anthos
BACKGROUND AND EXPERTISE

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 greg.anthos@tunnellconsulting.com.

EDUCATION
  • MBA, James Madison University
  • B.S., Industrial Engineering and Operations Research, Virginia Tech
Xachariah Kibbie
BACKGROUND AND EXPERTISE

Xach brings to Tunnell over 17 years of project and program management experience in the fields of clinical development, tech transfer, engineering, validation (computer, process, and equipment), product launch, consent decree programs  for biologics, device and combination products.    His areas of expertise include distribution, contract manufacturing of clinical and commercial products and management.  He is an experienced business transformation leader with a demonstrated track record in risk management, operational excellence, product strategy and stakeholder communication.

 

Prior to joining Tunnell, Xach was Senior Program Manager for Shire HGT where he specialized in the planning of multiple product launches from clinical to launch, business continuity/risk management program development and operational excellence. He managed high profile product launches and facilitated commercial, supply chain, regulatory and technical operation strategies.  At Shire, Xach won two awards for recognition for the development and facilitation of Merger and Acquisition programs based on Risk and OE methodologies, as well as the successful program management for Shire’s most lucrative product launch; a methodology adapted for every other product due to its success.   Previously, Xach was Senior Program Manager for Genzyme / Aventis Sanofi where he specialized in the program management and business transformation of a consent decree organization for engineering, tech transfer, manufacturing and equipment, utility and process validation functions, recognized by the verifiers as the bench mark of all consent decree programs.   Earlier positions included Tech Transfer project management at Pfizer Biotech (managing the launch against Pfizer’s competition for Pfizer’s most lucrative drug) and Manufacturing/Validation Engineering Project Manager at Formatech (Finish/Fill and Drug Development CMO); Validation Project Management (Utilities, Computer Systems, Process, and Equipment) at TKT, OI, and Lonza.

 

Contact Xach at xachariah.kibbie@tunnellconsulting.com.

EDUCATION
  • Graduate Studies:  Business, Pharmaceutical Processing, Computer Science, MIT PMP PDU’s
  • B.A., Lesley University, Cambridge, MA
  • A.A., Indian River State College, Ft. Pierce, FL
Glenn Lawrence
BACKGROUND AND EXPERTISE

Glenn Lawrence has 38 years of global experience in the pharmaceutical industry managing and executing process engineering activities for the design, construction, validation and startup of manufacturing facilities. His technical expertise includes vaccine processing, therapeutic protein processing, chemical processing, solid oral dose, sterile supply facilities and clean utilities. He has extensive knowledge in the design and execution of modular process equipment, single use bio-processing equipment, sterile processing, CIP and SIP and clean rooms. In addition, he is experienced in process safety management, potent compound containment and bio safety hazard control. He is also highly qualified in technology transfers, Six Sigma and Lean Manufacturing, regulatory and product licensure and quality and validation.

 

Prior to joining Tunnell, he spent 37 years with Merck & Co., where he held a variety of critical roles, including: Director, Engineering, Global Process Safety; Director, Engineering, Global Bio and Vaccine Process Engineering; and Director, Engineering, API/Chemical Process Engineering. He is a licensed Professional Engineer (P.E.), an ISPE “Certified Pharmaceutical Industry Professional” (CPIP) and a Six Sigma Green Belt.

 

Contact Glenn at glenn.lawrence@tunnellconsulting.com.

EDUCATION
  • B.S., Chemical Engineering, Michigan Technical University
Frédéric Lefebvre
BACKGROUND AND EXPERTISE

Frédéric brings to Tunnell over 15 years’ experience in the pharmaceutical industry, developing and implementing account strategies while also managing global and regional industrial pharmaceutical clients.

 

Prior to joining Tunnell, Fred was Global Account Director, Life Sciences with M+W Group, and engineering & construction organization where he strategically had responsibility for developing business and supporting major international pharmaceutical companies. Previously he was Account Manager at Catalent Pharma Solutions, CMO, where he was responsible for the development of manufacturing contracts and R&D services in Switzerland, France, Belgium, Israel and Eastern European countries. He also worked at Capsugel (a division of Pfizer), capsules and equipment producer, as Multinational Account Manager for Europe, Middle East and Africa.

Fred is fluent in French and English and skilled in Spanish.

 

He can be reached at frederic.lefebvre@tunnellconsulting.com

EDUCATION
  • Baccalaureat, Degree in Business and Marketing
Walter Matzmorr
BACKGROUND AND EXPERTISE

Walter brings to his role more than 28 years’ experience in plasma protein and biopharmaceuticals, process development, manufacturing and engineering. His expertise also includes aseptic processing, filling and lyophilization, good manufacturing practices (GMP), and process facility optimization and start up. He also has extensive experience in the biopharmaceutical industry and in-depth experience dealing with regulatory agencies in the US and Europe.

 

Prior to joining Tunnell, Walter was an independent consultant to companies in the US, Canada and Germany. Previously, he served as Vice President, Ireland Operations/Vice President Engineering and Process Development for Sangart, where he was responsible for process development, scale up and technology transfer. He has also held a variety of critical operations positions at a number of biotechnology companies, including Auxilium Pharmaceuticals, where he successfully transformed a development site into a GMP biotech manufacturing facility; DSM Biologics, where he designed a new large-scale cell culture facility; and Aventis Behring, where he served as Vice President, Operations and Head of Global Engineering.

 

Contact Dr. Matzmorr at walter.matzmorr@tunnellconsulting.com

EDUCATION
  • Dr.-Ing., Chemical Engineering, Universität Dortmund
  • M.S., Engineering, Technische Universität Dortmund
Susan Mozgai
BACKGROUND AND EXPERTISE

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.

 

Contact Susan at susan.mozgai@tunnellconsulting.com.

EDUCATION
  • B.S., Microbiology, Pennsylvania State University
  • MSJ, Pharmaceutical and Medical Device Law, Seton Hall Law School
Scott Myers
BACKGROUND AND EXPERTISE

Scott has more than 20 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 scott.myers@tunnellconsulting.com

EDUCATION
  • Graduate studies, University of Colorado, School of Pharmacy
  • BS, Pharmacy, Philadelphia College of Pharmacy and Science
Julia C O'Neill
BACKGROUND AND EXPERTISE

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.

 

Contact Julia at julia.o’neill@tunnellconsulting.com.

EDUCATION
  • MS, Statistics, University of Wisconsin
  • BS, Chemical Engineering, University of Maine
Alfred Riles
BACKGROUND AND EXPERTISE

Al Riles brings to Tunnell more than 35 years of experience in creating and implementing global HR processes. His expertise includes leadership training, organizational development, change management, employee relations and global recruiting and staffing – all firmly anchored in business-case analysis.

 

Prior to joining Tunnell, Al held a variety of positions at the Johnson & Johnson family of companies where he led and managed detailed process mapping at the global level for the training process that impacted 120,000 employees. As Worldwide Vice President, Human Resources, Johnson & Johnson-Merck, he directed all aspects of HR policies for employees in the U.S. and Europe and trained J&J executives on four continents. Previously, he served in a number of key positions in Human Resources for McNeil Consumer Healthcare, addressing succession planning, performance management, organizational development strategies and other critical HR issues.

 

Contact Al at al.riles@tunnellconsulting.com.

EDUCATION
  • M.A., Lehigh University
  • B.A., University of Portland
Mike Rutledge Ph.D.
BACKGROUND AND EXPERTISE

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.

 

Contact Mike at michael.rutledge@tunnellconsulting.com

EDUCATION
  • Ph.D., Pharmaceutical Chemistry, University of Florida
  • B.S., Pharmacy, University of Florida
  • B.S., Chemistry, University of Florida
Clifford J Sachs
BACKGROUND AND EXPERTISE

Cliff brings to Tunnell over 30 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 clifford.sachs@tunnellconsulting.com.

EDUCATION
  • MBA, Pharmaceutical Studies, Fairleigh Dickinson University
  • BS, Chemistry, State University of New York
Michael E Thomas
BACKGROUND AND EXPERTISE

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.

 

Contact Mike at mike.thomas@tunnellconsulting.com.

EDUCATION
  • MBA, Management, Lehigh University
  • MS, Statistics, Rutgers University
  • BA, Mathematics, Georgian Court University
Kip Wolf
BACKGROUND AND EXPERTISE

Kip Wolf brings to Tunnell more than 25 years of experience in 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. He has held various highly visible management positions at some of the world’s top life sciences companies.

 

Prior to joining Tunnell, Kip was a Consent Decree Champion at McNeil Consumer Healthcare (Johnson and Johnson), where he facilitated the integration of process and system changes for sustainability and operational readiness for certification preparedness. Previously he was Director, Business Operations and Portfolio Management at Merck & Co. and Associate Director, Process Excellence at Wyeth Pharmaceuticals (now Pfizer). He is a certified Project Management Professional (PMP) and a Program Management Professional (PgMP).

 

Contact Kip at kip.wolf@tunnellconsulting.com.

EDUCATION
  • MBA, Management, Eastern University
  • Graduate Studies, Drug Development, Temple University
  • BA, Management of Information Systems, Eastern University
Ellen Venezia
BACKGROUND AND EXPERTISE

Ellen is an accomplished account manager and business developer whose career, backed by decades of performing technical engineering design, has focused solely in the life sciences industry.

 

Prior to joining Tunnell she was the Sr. Account Manager in Business Development for Amec Foster Wheeler where she was responsible for the development of US and global life sciences client accounts. While at Amec Foster Wheeler, she managed relationships for many of the world’s largest international Pharmaceutical and Biopharmaceutical companies. Previously, she performed process engineering design services as well as business development for Middough and PS&S after completing many years of process design for Fluor Corporation and CE&IC in the North Eastern US.

 

Ellen can be reached at ellen.venezia@tunnellconsulting.com.

EDUCATION
  • BS, Chemical Engineering, Rutgers University