The Primera Team
Bibo Xu, PhD
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 Quality Assurance
Steve Grossman, Vice President of Quality Assurance, earned an M.S. from Seton Hall University. He has worked over 20 years within the Quality and Analytical areas in the Biopharmaceutical industry. Mr. Grossman has gained in-depth knowledge in large and small molecules, as well as devices such as Transdermal patches, 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, raw material, drug substance and drug product release testing. Mr. Grossman has managed numerous successful PAI and general regulatory and client inspections.
V.P. Business Development and 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 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 is an active member of the Water Environment Federation and the American Association of Pharmaceutical Scientists-Analysis and Pharmaceutical Quality (APQ) and Regulatory Sciences (RS).
V. P. Business Development
Elizabeth Oliver is a pioneer in the global generic pharmaceutical industry beginning her career in 1978. 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, criminal and commercial challenges establishing each as a market leader. Elizabeth has her AS, Phi Sigma Omicron, attended Marymount College (Fordham Univ), NYU in addition to continuous industry-related regulatory, FDA and patent workshops throughout her career.
Joe Shao, PhD
Director of Analytical Services
Dr. Joe Shao, 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 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.
Xiaorong Shen, PhD
Director of Analytical Services
Dr. Xiaorong Shen, Director of Analytical Services, earned a PhD. from Purdue Univ. She has been working in pharmaceutical industry for over 18 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 for flowability, wettability, and compressibility. She works closely with clients for drug product formulation support, process support, raw material testing, drug product testing, and stability studies.
Director of Bioanalytical Service
Ann Draghi, Director of Bioanalytical Service, earned an M.S. from City University of New York. Prior to joining Primera, Ms. 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 20 years experience in regulated bioanalysis with broad experience in FDA GMP and GLP regulation. Ms. Draghi’s knowledge and experience also covers a broad range of pharmaceutical analyses, 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.
Director of Biopharmaceutical Business
Sean Li, Director of Biopharmaceutical Business, earned an M.S. in Molecular Biology from St. John’s University and an M.S. in Cell Genetics from Beijing Normal University. Prior to joining Primera, Mr. Li worked for MedImmune/AstraZeneca, Eli Lilly and Immunomedics for over 18 years in cGMP/GLP regulated environments. He possesses comprehensive knowledge of biopharmaceutical characterization and analytical method development and validation strategy for monoclonal antibodies, and cell and gene therapy products (CGTPs). He led and fulfilled a number of analytical method development, optimization, qualification/validation and tech transfer activities for biologics with an excellent understanding of cGMP and regulatory agency guidelines in CMC related areas. Mr. Li is an expert with extensive experience in potency assays (cell-based bioassays, immunoassays, FACS assays & PCR assays) on various technique platforms for all phases of biologic drug development in a cGMP environment, including assay lifecycle management.