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.
As an executive with over two decades of experience in the biopharma industry, Michelle Calhoun has demonstrated a proven track record of success in leading global sales and marketing teams that have achieved impressive annual revenue targets of $1B+. Her extensive expertise in global CDMO sales, market development, business development, and strategic planning make her a valuable addition to the Scorpius leadership team, helping to build a robust commercial foundation for the organization.
Career highlights include recently serving as Vice President, Commercial Operations for Curia, where she played an integral role leading inside sales, proposals, communications, e-commerce, and marketing with a successful company rebrand. Prior to that, she spent 12 years at AbbVie CDMO as Head of Business Development, Sales & Marketing, and held various roles within Procurement and R&D.
Her academic achievements include a Bachelor of Science degree in Chemistry from Central Michigan University, as well as Project Management and Certified Purchasing Management certifications. She serves as an interim Chief Commercial Officer and as a Senior Advisor on the Executive Leadership Team at Scorpius BioManufacturing.
Matthew LeClair is the Vice President, Manufacturing Operations at Scorpius BioManufacturing. He is a 30+ year veteran in the biopharmaceutical industry, with extensive experience in all phases of development from R&D through commercial manufacturing. He has expertise in cell culture, manufacturing, technical operations, and site management. Prior to Scorpius, Matthew spent nearly 20 years at Takeda, including as site head at both international and U.S.-based biologics facilities. He then joined Abzena as the SVP and Site Head of Operations for the company’s San Diego CDMO facility.
He honorably served in the United States Navy as an Aviation Electricians Mate 2nd Class. His service experience included roles as Instrument Systems Specialist assigned to Aircraft Intermediate Maintenance Department – Avionics, an Instrument Shop Supervisor, a Collateral Duty Inspector (Quality Assurance), and a Nuclear Emergency Team Leader. Matthew earned his B.S. in Business Administration from Colorado Technical University.
Joe Payne is the Vice President of Quality & Regulatory Affairs at Scorpius BioManufacturing. Joe brings over two decades of biopharma expertise, and has extensive experience at both biopharmaceutical companies and CDMOs, including companies like Teva Pharmaceuticals (Manager, Operations & Risk Assessment), Alcami Corporation (VP, Quality & Regulatory), and Tergus Pharma (VP, Quality & Compliance).
He also provides quality and regulatory consulting services as the owner of JEP Consultant Services, where he leverages his drug product development, operational execution, and executive management experience to guide QC and compliance strategies for a wide range of companies in life sciences.
Joe earned a B.S. in Chemistry from Hampden-Sydney College in Virginia.
Brian O’Mara is the Vice President, Process Sciences at Scorpius, which operates a multi-use, cGMP compliant contracting manufacturing facility. He 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.
See more insights from Brian O’Mara in his blog, “What Does It Take to Be a Biologics CDMO Serving Today’s Mammalian Clinical Manufacturing”, and his “Four Critical Aspects of Clinical Development, Manufacturing, and Analysis” webinar.
Steve joined Scorpius as the Vice President of Business Development; he brings extensive experience in various roles throughout business development. He spent 12 years in the industrial gasses industry with Linde Gas, and then joined W.L. Gore in the Startup Biopharmaceutical division working on a Commercial Business/Market Development role for Bulk Drug Substance Single-Use items. Prior to joining Scorpius, he spent 3 years with Catalent Biologics, focused on Drug Substance Business Development in the US for early-stage clinical programs with clients to bring life-changing therapies to the market.
Steve holds a BS in Chemical Engineering from Pennsylvania State University and an MBA in Marketing from Robert Morris University.
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.
Read more from Chris Barnett in his article, “Evaluating Single-Use Technologies for Biomanufacturing”.
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.
Dr. Samir Lakhashe is Director of Bioanalytical 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.
Hear more from Samir Lakhashe in his article, “Analytics for Biomanufacturing and Clinical Trials of Biomanufactured Products”.
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.