David Halverson is the General Manager of Scorpion. He has over 30 years of experience in the contract research and CDMO industry, including many of the largest CROs in the industry. David started his career with Hazleton (Covance), working as a Study Director in the drug metabolism and pharmacokinetics division for 11 years.
He moved on to PPD, where he spent five years running a GLP/GMP LCMS laboratory and started a program management/technical field sales team. From there, he joined Quintiles and was the Head of North American Business Development (four years) before moving to Cambridge, England to head up the European Sales Team for Huntingdon Life Sciences. After working in Huntingdon for four years, David worked as the President of Protea for three years, working in the Large Molecule MS and Diagnostic space to help to develop an MS imaging-based diagnostic for melanoma. After Protea, David moved to Concept Life Sciences where he was the Head of North American Business Development for three years.
After receiving a commission as an officer in the US Army, David honorably served for 13 years as an officer in the Armor Corp and is a Veteran of Desert Shield/Storm and Operation Joint Guard.
Mike Fiske is Vice President of Manufacturing Sciences at Scorpion, 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.
Nick Raja is responsible for driving analytical development at Scorpion, developing custom assays to meet client’s needs, providing scientific insights, overseeing the execution of assays, and providing quality data in a timely manner. His team develops and performs many assays, including cell-based, potency and reporter, and neutralizing assays. He has developed many immune cell killing assays and provides molecular and genome editing services and oversees the clinical GMP lot release and stability protocols following regulatory compliance guidelines.
Nick has over 20 years of experience in the biotech, pharmaceutical and CRO space, working on antivirals, vaccine development, assay development, clinical immunology, rare diseases, gene therapy, cancer biology, and immunology. He has broad knowledge of molecular biology, cell biology, protein biology, clinical immunology, and regulatory needs.
Nick trained at Cleveland Clinic and Brown University and authored a number of peer reviewed scientific publications. He received his Ph.D. in Microbiology at Madurai Kamaraj University.
Dr. Samir Lakhashe is Director of Bioanalysis at Scorpion. 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.
Noel Martinez is the Senior Manager of Quality Assurance at Scorpion. He organizes work systems, and sustains and leads teams in Quality Assurance, Regulatory Affairs, Auditing, Manufacturing and Technology Transfer.
Noel has over 42 years of experience in pharmaceutical research/development, manufacturing, FDA compliance and engineering, including 22 years in Project Management. He has served as Director of Quality Assurance and Regulatory Affairs for large pharmaceutical and start-up companies. He has also led several projects from their start through to FDA approval. Noel has FDA cGMP Auditing experience and ISO certification experience.
Kenna Harris is Head of Sales & Marketing at Scorpion and has spent over 19 years working in the contract research environment, with an emphasis on proteomics and oncology. She began her career as a program manager and spent five years leading a team to develop and characterize monoclonal and polyclonal antibodies. After this, she moved into business development with Taconic, specializing in the creation and breeding of GEM models.
Kenna later moved to Cell Signaling Technology as a proteomics specialist then subsequently to a similar role at SomaLogic. She then joined Mitra Biotech to help organizations create effective translational studies for oncology and developed a team at Concept Life Sciences specializing in the sale of chemistry and immunology services. Kenna is a graduate of UC Davis, with a BS in Biology, focusing on Neurobiology, Physiology and Behavior.
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, Process Development at Scorpion, 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.
Bryan Alyea is Head of Facilities and Operations at Scorpion, which operates a multi-use, cGMP-compliant, contract manufacturing facility designed for the development and manufacture of advanced therapies. He has more than 20 years’ experience in the cGMP cleanroom operation and design industry as a facility engineer.
As Head of Facilities and Operations, Bryan provides valuable knowledge of the facility operations including specialized water for injection and clean steam systems. Bryan is well versed in cGMP validations requirements, environmental and building monitoring, inventory control and information technology for regulated industries
Bryan honorably served in the United States Army in an infantry role. He is a Veteran of the Persian Gulf Wars; Desert Shield/Desert Storm and Liberation of Kuwait with the XVIII Airborne Corps.