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. He previously held positions as 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.

Over 10 years of broad drug discovery and development experiences, including industry experiences at WuXi AppTec Co., Ltd., API Co., Ltd and ChemExplorer Co., Ltd., where he was responsible for the development of drug substances with increased responsibilities. With a Ph.D. and an MS from Shanghai Jiao Tong University, and a BS from Nanjing University of Science and Technology.

About 4 years' experience in drug impurity research and program management. Formerly Associate Director at Suzhou Primelong Life Science and Technology Co. responsible for genotoxic impurities’ evaluation, screening, method development and validation and Director Assistant at Zhejiang Huahai Pharmaceutical Co., Ltd. With a B.S. in Pharmacy from Central South University-Xiangya medical school, an M.S. in Pharmaceutical Chemistry from Chinese Pharmaceutical University and a Ph.D. in Organic Chemistry from Zhejiang University.

Master from China Pharmaceutical University; 5 years of relevant work experience in pharmaceutical,worked in Nanjing Sanhome Pharmaceutical Co., Ltd. Mainly engaged in the development of new drugs and generic drugs, covering a variety of dosage forms, such as tablets, capsules, injections, freeze-drying, etc., involving a variety of processes, such as direct powder pressing, wet granulation, dry granulation, terminal sterilization, freeze-drying process, bactericidal filtration, etc. The projects covered the preclinical, clinical phase I, clinical phase II, and manufacturing stage, and led the team to obtain several IND approvals and generic drug approvals.

Over 15 years’ experience in GLP Bioanalytical industry. Formerly worked as Director at Bioanalytical Services Unit of WuXi AppTec. in charge of international business of small molecules, participating in preparing and reception of inspection from domestic and international regulatory agencies and clients. Be invited as a lecturer by NMPA Institute of Executive Development as an organizer and lecturer for NMPA training courses in past years. Master Degree in Biochemistry and molecular biology from Huazhong University of Science and Technology.

Over 10 years’ experience in establishing and operating of GXP regulation Lab including hardware/software qualification, service on LC-MS/MS System. Worked for WuXi AppTec, Medline and Waters. Joined XIHUA in 2016, be in charge of GLP regulation Lab establishing and operation, and management of network and data security. Invited to perform training of equipment management and maintenance. And as lecturer by NMPA Institute of Executive Development. Bachelor in Chemistry and Master in Analytical Chemistry from Jilin University.

Earned an M.B.A from Boston College Graduate School of Management and a Bachelor’s degree in Toxicology from St. John’s University. In addition, she completed a course in Pharmaceutical Regulatory Affairs at Lehigh University in 2010. With over 35 years of experience in the CRO industry, she is well versed in every aspect of the business, having worked in Analytical Chemistry, Quality Assurance, and Business Development departments over her long and illustrious career. Ms. Buckwalter is a firm believer continuous education and assists our clients utilizing her extensive experience and knowledge.

With an M.S. from Seton Hall University, he has worked for 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.