Founder and President
Dr. Bibo Xu is the Founder and President of Primera, establishing the company in February, 2002. Dr. Xu holds a Ph.D. in Genetics from Pennsylvania State University. Through his nearly 30 years of experience, Dr. Xu has honed a wide array of technical skills within the Pharmaceutical Biotechnology, and Agrochemical industries. His previously held positions include Group Leader at Centre Analytical Laboratories and Senior Chemist at BASF. His managerial acumen, tenacity and determination to succeed turned his dream into the thriving and growing company that is Primera today.
Vice President of Operations
Steve Grossman, Vice President of Operations, earned an M.S. from Seton Hall University. He has worked for over 25 years managing Analytical Laboratories and Quality areas in the Biopharmaceutical industry. Mr. Grossman has gained in-depth knowledge in large and small molecules, as well as devices such as transdermal systems, working for companies such as Johnson & Johnson and Eli Lilly. He managed Quality Control laboratories that oversaw the testing of clinical and commercial products. His work encompassed method development and validation, drug substance and drug product and raw material release testing. Mr. Grossman has managed numerous successful PAI and general regulatory and client inspections.
Vice President of Quality Assurance
Dr. Charles Stewart Jr., Vice President of Quality Assurance, earned a Ph. D. from the University of Massachusetts. He has been working in the pharmaceutical industry for over 25 years with extensive experience in Quality Assurance. Dr. Stewart has gained in-depth knowledge in large and small molecules, working for companies such as Douglas Pharmaceuticals and Meda Pharmaceuticals. His experience in analytical science and his knowledge of regulations greatly enhance the quality of projects, in both the scientific aspect as well as in the regulatory aspect.
Vice President of Business Development & Client Services
Bianca Buckwalter, Vice President of Business Development and Client Services, with an M.B.A from Boston College Graduate School of Management. With over 35 years of experience in the CRO industry, she is well versed in every aspect of the business, having worked in departments from Analytical to Quality Assurance to Business Development over her long and illustrious career. Ms. Buckwalter is a firm believer in continuous education and completed a course in Pharmaceutical Regulatory Affairs at Lehigh University in 2010. She has previously worked with IAL as the Director of the Pharmaceutical Division and as the Director of Regulatory Affairs and Business Development. She has been active in the Water Environment Federation and the American Association of Pharmaceutical Scientists-Analysis and Pharmaceutical Quality (APQ) and Regulatory Sciences (RS).
Vice President, Business Development
Elizabeth A. Oliver, Vice President of Business Development, with 30+ years global experience in pharmaceutical leadership, is a pioneer in the global generic pharmaceutical industry. She has held strategic leadership roles as Executive Vice President of Flavine North America, Vice President of Lek (Novartis), Vice President of Business Development for Pharmaceutical Sourcing Partners and Primera Analytical Solutions Corp. In each of her positions she has been able to leverage her deep and broad experience and relationships in both the human and animal health industry, innovator and generic, to support the successful approvals and commercialization of NDA, ANDAs, NADAs and ANADAs. Highly skilled in communication, Elizabeth has worked closely with API manufacturers and formulation companies in areas of quality, product development, regulatory, marketing, product portfolio, patent landscape, supply chain, legal and corporate matters, allowing these companies to withstand FDA, political, investigations and commercial challenges establishing each as a market leader. Elizabeth has attended Marymount College (Fordham Univ), NYU in addition to continuous industry-related education in regulatory, FDA and patent workshops throughout her career.
Senior Director of Analytical Services
Dr. Joe Shao, Sr. Director of Analytical Services, holds a Ph.D. in Chemistry from Columbia University. Prior to joining Primera, Dr. Shao worked for Bristol-Myers Squibb and Ligand Pharmaceuticals. With more than 20 years of experience working in pharmaceutical development, Dr. Shao’s knowledge and experience covers a broad range of pharmaceutical analyses, including gas and liquid chromatography, mass spectrometry, impurity identification, and various types of wet chemistry per USP procedures. Dr. Shao has contributed to the pharmaceutical science community with a number of peer reviewed publications and holds inventorships of multiple pharmaceutical patents. Dr. Shao is also an expert in emerging areas such as Elemental Impurities and Extractable/Leachable studies.
Senior Director of Analytical Services
Dr. Xiaorong Shen, Sr. Director of Analytical Services, earned a PhD. from Purdue Univ. She has been working in the pharmaceutical industry for over 20 years with extensive experience in both formulation development, analytical method development and validation for assay, impurity, and dissolution. She also has strong background and experience in pre-formulation study, including pH dependent solubility and stability, structure characterization by DSC, TGA, and XRD, drug-excipient compatibility, prototype formulation. She works closely with clients for drug product formulation support, process support, raw material testing, drug product testing, and stability studies. She has in-depth experience of drug product end use stability study, including reconstituted injection stability, large volume parenteral solution stability, enteral feeding tube study, use of liquids/soft foods as vehicles in drug administration, and etc.
Senior Director of Bioanalytical and LC-MS/MS Services
Ann Draghi, Sr. Director of Bioanalytical and LC-MS/MS Service, earned an M.S. from City University of New York. Prior to joining Primera, Mrs. Draghi worked for Purdue Pharma (8 years) and Novartis (11 years) as a Principal Scientist, specializing in LC-MS/MS method development and validation, as well as coordinating routine sample analysis to support preclinical and clinical studies. She has over 25 years experience in regulated pharmaceutical development with broad experience in FDA GMP and GLP regulation. Mrs. Draghi’s knowledge and experience also covers a broad range of pharmaceutical analysis, including liquid chromatography, mass spectrometry (especially in traceable amount impurity quantitation for API and finished products), and method transfer/verification based on USP/EP procedures.
Senior Director of Bioanalytical Services
Dr. Duxi Zhang, Senior Director of Bioanalytical Services, earned his Ph.D. degree in analytical chemistry (mass spectrometry) from Purdue University. Dr. Zhang joined Primera with over 20 years of global bioanalytical experience from pharmaceutical industry and contract research organizations including Alliance Pharma, Medpace, Wuxi AppTec and Bristol‑Myers Squibb. Dr. Zhang has extensive experience in laboratory operations, project management, client collaborations and lab-based expertise in regulated bioanalytical sciences for both small molecule and large molecule drug development under GLP and GCP.