Tania Weiss completed studies at the University of Michigan-Ann Arbor, with a B.S., M.S. and Ph.D., all in Chemistry or Biochemistry. She successfully worked in academia at the University of Chicago, Departments of Biochemistry and Molecular Biology; at Stanford University, Department of Biological Sciences; and at the University of California-San Francisco (UCSF), Department of Medicine. As adjunct faculty member at UCSF, Dr. Tania Weiss, built and staffed her own academic research laboratory and then subsequently founded and over the past 25 years systematically built and refined Marin Biologic Laboratories, Inc. CRO services and manufacturing businesses.
During her post-doctoral training at the University of Chicago with Eugene Goldwasser Ph.D., she was the first internationally to generate and characterize important new monoclonal antibodies specifically directed against erythropoietin and further trained with Drs Robert Shimke Ph.D. and Leonard Herzenberg Ph.D. in Stanford University’s flow cytometry and molecular biology laboratories. Dr. Len Herzenberg made major advances in research in clinical immunology and cell biology and is perhaps best known for developing advanced technology for fluorescence flow cytometry and hybridomas and made a very significant number of important and fundamental discoveries in lymphocyte biology.
Tania has published many significant papers, abstracts and patents. Also, she is often a speaker at national scientific conferences and chaired both the San Francisco Bioscience Forum and the American Association of Pharmaceutical Scientists. In 1995, Dr. Weiss became one of the few woman-founded and -owned private CRO’s, Marin Biologic Laboratories, Inc. Tania Weiss has a very solid reputation with the FDA and in providing successful creative and cost-effective solutions to client problems and generating world class results.
Peter Ralph, Ph.D., MarinBio Vice President of Scientific Affairs
Peter completed his B.A. and M.S. in Physics at Yale University and the University of California-Berkeley, respectively and his Ph.D. in Biology at the Massachusetts Institute of Technology. Dr. Ralph has held academic positions at the Salk Institute for Biological Studies in La Jolla, CA and Sloan Kettering Institute for Cancer Research/Cornell Medical School, where he was an Assistant Professor and then Associate Professor. Subsequently, Peter joined the biotechnology industry and was the Project Leader responsible for cloning the gene for M-CSF (Macrophage-Colony Stimulating Factor, a secreted cytokine which causes hematopoietic stem cells to differentiate into macrophages or other related cell types) at Cetus Corporation (which was later acquired by Novartis). Peter Ralph was subsequently employed at Genentech for nine years as Head, Research Immunology Department and in Genentech’s Bioassay Method Development.
Dr. Ralph has over 120 peer-reviewed publications and 24 issued patents. He is very well known for his development and patented methods to detect Herceptin and was the developer of the biometric GLP potency assay for Rituximab (anti-CD-20 human monoclonal antibody). During his 14-year tenure at Marin Biologic Laboratories he has expertly managed and successfully completed many hundreds of different projects for diverse clients, many of which were highly complex and intricate.
Dr. Mallavia performed his Ph.D. studies at the Autonoma University in Madrid (Spain) studying the effects of different inflammatory pathways over macrophage and muscle cells in the field of cardiovascular disease after obtaining his M.S. in Biology in the Complutense University also in Madrid. Following his research career, he moved to the Department of Medicine at the University of California San Francisco, where he continued his post-doctoral work studying different aspects of the innate and adaptive immune systems in the context of lung disease, especially after lung transplantation.
During his academic career Dr. Mallavia has published more than 25 peer reviewed papers and has developed different in vitro and in vivo assays from neutrophil extracellular DNA trap quantifications to different flavors of intra-vital life 2-photon microscopy methods.
In 2019, he joined Marin Biologic Laboratories to continue with the generation and development of different protocols and assays useful to many other companies.
But the most distinctive value of Dr. Mallavia is that he always wants to know WHY? Always willing to go the extra mile to answer the questions of HOW things work and WHERE can we improve things to make the experiment better, easier and simpler to understand.
Kirit is a seasoned professional with a proven track record in operations, business development, alliance management, negotiating and closing deals, including investments, divestitures and acquisitions. He has strategic and operational expertise with companies at various stages of the business life cycle including inception to profitability. Kirit Patel is a highly experienced and solid team player with outstanding leadership, interpersonal and communication skills. He is an excellent operations and alliance management director, with very significant client and management skills and with successful national and international work experiences with fortune 500 companies in Europe, USA, Middle East, Russia, South Africa, India, Australia and Far East.
Chirag completed his B.A at California Polytechnic State University and M.B.A. at Saint Mary’s College-Moraga, CA. He is a Certified Quality Auditor and Certified Software Quality Engineer who develops, maintains, and executes company GMP and GLP quality systems. Chirag reviews and edits quality agreements between MarinBio and clients; investigates and documents deviations, CAPA’s and OOS; facilitates vendor and supplier audits; responds to regulatory and client audits received by the company; and oversees facility, equipment and computer system validations.
Previously Chirag Asaravala successfully completed quality and compliance independent consulting for Crescendo Bioscience, RedPath Integrated Pathology and Healthcare Innovations. He was also previously employed as Director of Quality & Compliance at Tethys Bioscience, Inc. where he was responsible for developing corporate compliance programs in accordance with the law and OIG guidance’s for pharmaceutical manufacturers and clinical (CLIA) laboratories; led supplier and partner audits; led company liaison for audits by regulatory agencies; developed promotional and marketing materials review policy and committee for compliance with FDA regulations for promotional materials and activities; led gap analysis and implemented corrective measures, of clinical laboratory billing and reimbursement practices; was the Designated Privacy Officer for HIPAA; and developed company HIPAA/HITECH privacy and security policies and trained all employees and new hires.
Prior to this time, Chirag was Associate Director, Compliance at Novartis Vaccines & Diagnostics, Inc. where he directed the Diagnostics Division Compliance and Training groups (total staff of 10); managed FDA and health authority inspections and audits; led the audit program of key suppliers, distributors and partners (70 total); Implemented Key Performance Indicators (KPI’s) for Quality metrics; developed and led remediation of the Supplier Quality Management program; and implemented plans and achieved elimination of deviation/discrepancy backlogs. He was also Manager of Quality at Chiron Blood Testing, where he managed the staff of QA Specialists and Analysts; was Core team member for new instrumentation and software development; successfully launched 4 new medical device hardware/software products in the US and ex-US; ensured products were compliant to FDA, CE, and ISO Design Control Standards and was lead auditor for internal and supplier audits. Prior to this, he was Regulatory Compliance Associate at Chiron Corporation where he led and coordinated FDA, EU, MCA, and other regulatory agency inspection; reviewed regulatory submissions and documentation; Reviewed IQ, OQ, and PQ protocols and reports; provided compliance guidance to Regulatory Affairs, QA/QC, and Manufacturing; and participated in ISO certification.