Industry leaders who are dedicated to the future of bioanalysis.
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TitleCo-Founder and Chief Scientific Officer
DegreesPh.D. Analytical Chemistry - University of Rhode Island B.S. Chemistry - Washington State University
BiographyDr. Shane Needham received his B.S. degree in chemistry from Washington State University and his Ph.D. in chemistry from the University of Rhode Island. Dr. Needham is Co-Founder and Laboratory Director of Alturas Analytics, Inc. Dr. Needham manages all scientific aspects of the LC-MS/MS bioanalytical contract laboratory at Alturas Analytics, Inc. Currently, Dr. Needham’s work is focused on the development and validation of assays for the determination of therapeutic agents and biomarkers from biological matrices. His laboratory has been a leader in the area of dried blood spot (DBS) analysis, microflow LC-MS/MS and GC-MS/MS to support DMPK research. Dr. Needham has over 100 publications and external presentations in the area of LC/MS. He has over 25 years of LC/MS and analytical lab experience in the drug discovery through drug development stage in the pharmaceutical industry. He previously worked for Pfizer in Groton, CT where he developed and validated GLP and non-GLP LC-MS/MS methods for the trace analysis of drugs and metabolites in biological fluids. He also performed in vivo and in vitro structure elucidation studies of drugs and metabolites using HPLC/MS/MS and HPLC/MSn instrumentation. Dr. Needham has LC/MS experience working with triple quadrupole, single quadrupole, ion trap, time-of-flight and quadrupole time-of-flight instrumentation. His area of academic research included the development of optimized stationary phases to improve the assay of pharmaceuticals by HPLC/MS. Dr. Needham has been the chair and organizer of several workshops at national conferences including program chair of the 2013 CPSA-USA conference. Dr. Needham also teaches LC/MS courses at international conferences including, CPSA, Pittcon and AAPS conferences. Dr. Needham is also a reviewer for several peer reviewed journals including, Bioanalysis, Journal of Chromatography, Analytical Chemistry and Journal of Chromatographic Science. Dr. Needham also serves on the editorial board for the publication, American Pharmaceutical Review. Dr. Needham is a member of the American Chemical Society, American Society for Mass Spectrometry, American Association of Pharmaceutical Scientists and the International Society of the Study of Xenobiotics.
TitlePresident
DegreesB.S. - Washington State University
BiographyRobin graduated with a B.S. in biology and genetics from Washington State University. After helping to start two successful environmental testing laboratories, Robin became a cofounder of Alturas Analytics, Inc. in 2000. As president, Robin manages the business operations side of Alturas Analytics as well as performing all duties required of Test Facility Management. Robin is responsible for assuring Alturas’ full regulatory compliance as well as its financial welfare. In 2007, Robin was appointed to the Idaho Innovation Council by the governor of Idaho. In 2010, she was one of the finalists for Idaho Woman of the Year. In 2013, Robin was appointed by Idaho Governor C.L. (Butch) Otter to the Idaho Economic Advisory Council where she continues to serve as Region II Representative on the seven-member council, which advises the governor and Department of Commerce on economic development policy and block grant awards. Robin is also a member of the Higher Education Research Council, providing her knowledge to serve the Idaho State Board of Education. She is a board member of the University of Idaho Research Foundation and the Board Secretary/Treasurer of Gritman Medical Center in Moscow, ID.
TitleDirector of Business Development
DegreesB.S. - Florida Atlantic University
BiographyMs. Hoffman has a history of over 25 years in the bioanalytical CRO and applied life sciences industries from both the scientific and business perspectives. The primary objective as the Director of Business Development at Alturas Analytics, Inc. is to develop new and maintain existing client relationships and to guide controlled growth of the company’s business by diversification of the client base and service offerings to meet 2020 goals. Ms. Hoffman came to Alturas Analytics, Inc. from the specialized field of accelerator mass spectrometry services as Director of Marketing and Sales at Eckert & Ziegler Vitalea Science. She served as primary interface between Vitalea’s scientific team and Sponsors with the goal of developing loyalties that encourage repeat business. Prior to joining Vitalea Ann was the strategic account manager at Tandem Labs responsible for the company’s largest accounts worldwide. She was Tandem’s first Business Development Director and was instrumental in growing the company from start-up to a major Bioanalytical CRO with a reputation for quality and personalized service. Ann has been involved in product launches of early commercial ion trap systems at Torion Technologies, Thermo Fischer Scientific (formerly Finnigan Corporation) and time-of-flight mass spectrometers at Applied Biosystems (formerly Perseptive Biosystems) directed to early adopters of new technologies. She started mass spectrometry user groups in the greater Salt Lake City, Denver, and Seattle areas bringing scientists together across a broad spectrum of applications to engage in open exchange of ideas. She is a member of the American Society for Mass Spectrometry, American Association of Pharmaceutical Scientists and CACO Pharmaceutical and Bioscience Society.
TitleExecutive Laboratory Manager
DegreesPh.D. Pharmacology - University of Colorado B.A. English and Zoology - University of Idaho
BiographyDr. Jennifer Zimmer received her B.A. degree in English and Zoology from the University of Idaho and her Ph.D. in Pharmacology from the University of Colorado Health Sciences Center. Dr. Zimmer is responsible for the overall operations of the Alturas Analytics laboratory. She oversees the generation of quality assays, data and reports as well as compliance with all procedures and regulations. Dr. Zimmer works laterally with the quality assurance unit (QAU) to assure the laboratory is compliant with the latest standards and guidance. Dr. Zimmer is an active participant in the Canadian for Analytical and Bioanalytical Sciences (CFABS) and the Global CRO Council and a member of the American Society for Mass Spectrometry. To date Dr. Zimmer has more than ten publications in the field of bioanalysis.
TitleIT Manager
DegreesPh.D. Physics - University of Idaho MS Computer Science - University of Idaho BS Physics - Fudan University
BiographyBo is the IT Manager at Alturas Analytics, Inc. As modern instruments rely heavily on computers and IT technologies to acquire, process, and store data, it is vitally important for a modern laboratory to have a robust and secure IT environment. As a GLP and 21 CFR Part 11 compliant laboratory, Alturas Analytics must maintain the highest standards in its IT systems to ensure the integrity and security of electronic data. This is exactly what Bo and his department do. Bo holds multiple IT vendor certifications as Systems Engineer and DBA. His 17 years of IT experience in analytical laboratory settings allows him to effectively perform system planning, validation, and management.
TitleQuality Assurance Manager
DegreesB.S. Chemistry, with a minor in Mathematics- Minnesota State University Moorhead
BiographyDave Schumacher, RQAP-GLP since 2004, is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC/MS/MS and ligand binding) and formulation assays. With a strong laboratory background, Dave is known for his GLP auditor skills specializing in analytical sciences. With over 20 years in Quality Assurance, Dave oversees the Alturas Analytics Quality Assurance program, providing advice and expert insights to FDA requirements and regulations. His attention to detail and contributions to the Alturas QA Team add significant value to Alturas Analytics. He is considered by his colleagues to be a mentor and a source of regulatory insights. In the community on a volunteer basis, Dave provides safety communications for a number of special events to prepare licensed amateur radio operators for actual disasters where other forms of communication may not be available.
TitleSenior Scientist
DegreesB.S. Chemical Engineering - Washington State University
BiographyAfter serving in the United States Army, Chad received his B.S. in chemical engineering from Washington State University. As a senior scientist at Alturas Analytics, Inc. Chad’s primary focus is LC-MS/MS method development, validation and sample analysis for small molecule drugs and peptides in accordance with GLP guidelines. He has more than ten years of experience in bioanalysis and more than 15 years in analytical chemistry. In addition to his LC-MS/MS and GC-MS/MS method development and sample analysis duties, Chad heads the LC-UV analysis, protein binding determination and antibody drug conjugate (ADC) programs at Alturas.
An Interview with Shane Needham on data sharing, ALICE technology and co-founding a CRO
