Dr. Kutzer brings more than 25 years of experience in the pharmaceutical and biotech industries, managing successful contract development and manufacturing organizations. He previously served as President and Chief Executive Officer of Alcami Corporation, a leading provider of development, analytical testing, and manufacturing services to the pharmaceutical and biotech industries. Prior to this, he served as President, Divisional CEO and Chief Operating Officer of the Pharma Biotech & Customer Manufacturing division of Lonza Group AG, a multinational manufacturing company serving the pharmaceutical and biotechnology sectors, where he had full oversight of the division, which generated over $1.6 billion in annual sales.
Dr. Kutzer also served as a member of the Executive Management Board of Lonza Group AG; President of Lonza Biologics Inc; Chairman of the Board of Directors of Lonza Singapore Inc; Chairman of the Board of Directors of Teva-Lonza TL Biopharmaceuticals AG; Chairman of the Board of Directors of Lonza Biologics plc.; and President and Chairman of Lonza Inc. He previously served as an Executive Director on the board of directors for the Drug, Chemical & Associated Technologies Association (DCAT). Dr. Kutzer earned a master’s degree in Chemical and Process Engineering and a Ph.D. in Engineering Sciences from the Technical University of Munich, Germany.
Michelle Calhoun brings more than 20 years of experience in the biopharma industry with deep expertise in leading global sales and marketing teams who have achieved $1B+ annual revenue targets. Her executive leadership in global CDMO sales, market development, business development and strategic planning will help with further building a strong commercial foundation for Scorpius. She most recently held the position of Vice President, Commercial Operations for Curia. Prior to that she headed up Business Development, Sales and Marketing for the last 12 years for Abbvie CMO and held various prior roles within Procurement and R&D.
She earned her Bachelor of Science degree in Chemistry from Central Michigan University along with obtaining Project Management and Certified Purchasing Management certifications.
Gary Welch has 30 years of experience as a bioprocess operations leader, with extensive knowledge in cell line development, process development, analytical and formulation development, manufacturing, and engineering.
Mike Fiske is Vice President of Manufacturing Sciences at Scorpius, which operates a multi-use, cGMP-compliant, contract manufacturing facility designed for the development and manufacture of advanced therapies. He has more than 30 years in the biotechnology industry as a protein chemist, analytical biochemist, process development scientist and cGMP operations manager.
As Vice President, Mike provides leadership for all aspects of ongoing facility operations, including new facility design, construction and validation, technology transfer, process and analytical methods development, cGMP manufacturing as well as characterization and QC release testing of preclinical and clinical grade advanced therapy biologic products. He also helps clients with preparation of regulatory documents and interactions with regulatory agencies.
Mike has an extensive background in cGMP compliance, including manufacturing facility design, construction, and validation. He also has considerable experience in biologics process development, analytical test method development, and validation, as well as cGMP manufacturing and QC release testing of clinical-grade biologics including vaccines, protein therapeutics and cell therapy products. Mike holds a Master of Science in Biochemistry from SUNY Binghamton.
Brian O’Mara is the Senior Director of Manufacturing Science and Technology at Scorpius, which operates a multi-use, cGMP compliant contracting manufacturing facility. As Senior Director, Brian is responsible for the cGMP manufacturing-related activities of biologics, including technology transfer, process characterization, facility fit, and manufacture of clinical grade biologics.
Brian has more than 20 years of industrial biotechnology experience in downstream process development of early- and late stage protein therapeutics from mammalian and microbial expression systems. He also has extensive experience the development of protein conjugates, including antibody drug conjugates (ADCs), bi-specifics, and PEGylated molecules. He has experience in scale-up and technology transfer, CDMO management, process characterization, preparation and oversight of PPQ campaigns, and associated CMC regulatory filings.
Dr. Samir Lakhashe is Director of Immunology & Clinical Analytical Sciences at Scorpius. He has extensive experience working with clients and collaborators to define analytical target profiles (ATP), identify critical quality attributes (CQA), and contribute to bench-to-bedside translation of novel IND therapies. His recent work focused on the development and management of analytical process life cycles for cell therapy products such as mesenchymal stromal cells (MSC), engineered MSC, engineered tumor infiltrating lymphocytes (TIL), and CAR-T cells.
Samir has over 20 years of experience in the development, implementation, and validation of analytical test methods in regulated laboratories. This includes analytical method development, validation, and QC testing in GCP, preclinical GLP, and cGMP clinical manufacturing. His expertise spans a wide variety of disciplines, including immunology, cell biology, virology, molecular virology, and protein chemistry-based analysis.
Samir earned a PhD from the Savitribai Phule Pune University, formerly University of Pune, and did postdoctoral training at the Dana-Farber Cancer Institute at Harvard Medical School, Boston.
Yamiha Pulliza is the Quality Assurance Director at Scorpius, which operates a multi-use, cGMP-compliant, contract manufacturing facility designed for the development and manufacture of advance therapies. She has 19 years of experience in cGMP-compliant manufacturing.
Yamiha is well versed in cGMP validation requirements as well as cleanroom maintenance and monitoring and materials management.
Yamiha honorably served in the United States Army National Guard as a Medical Lab Technician. She is a Veteran of Operation Iraqi Freedom.
Lise is the Director of Program Management at Scorpius and has over 30 years’ experience in Scientific research and the CDMO industries. Under Lise’s guidance, her team manages the full life cycle of a program from development to commercialization, and ensures each client has a positive experience at Scorpius.
She began her career in Tennessee and North Carolina, developing antibodies for lymphomas and performing nephrology and infectious disease research. Lise began her Project Management career at organizations like Veriq and Becton Dickenson, where she managed the successful development and marketing of commercial programs as well characterization of antibodies to develop novel biomarkers for oncological applications.
She transitioned to CDMO Program Management in 2012 with KBI, with responsibilities for all aspects of clinical programs, from process development through manufacture. Lise joined Fujifilm Diosynth in College Station, Texas in 2017 as a Director of Program Management. She was responsible for Portfolio Management in the Biologics section, leading a team of coordinators and Program Managers to manage manufacturing readiness, milestone adherence, and client-company communications on programs.
Lise is a graduate of Utica College of Syracuse University with a BS in Biology.
Chris Barnett has more than 35 years in the biotechnology industry as a molecular biologist, protein chemist, analytical biochemist, physical biochemist, formulations, and process engineering. He serves as Senior Director, Head of Process & Analytical Development at Scorpius, which operates a multi-use, cGMP compliant contracting manufacturing facility designed for the development and manufacture of regenerative medicine and gene therapy.
He has extensive background in R&D program management, process development and technology transfer to manufacturing, in both the industrial and pharmaceutical arena. He also has extensive experience as a technology leader of business units to develop and introduce new products to market and manage technical implementation of those products.
As Senior Director, Chris provides technical and business leadership for all aspects of process development, technical transfer, and analytical methods development for regenerative medicine products for phase 1 and phase 2 clinical testing. Chris is also integral in customer-facing activities during initial client interaction and ongoing projects and programs.