Our People

Co-founder, Chairman & CEO

• 21 years of pharmaceutical research experience, including 8 years at Merck Research Laboratories and Merck Manufacturing Division. Supported physical characterization, API form evaluation and selection of over 50 compounds at early and late stage of development. Leading inventors of many polymorph patents for marketed drug products, including Januvia, Isentress, etc. Obtained a B.S. in Chemistry from Peking University and a Ph.D. in Chemistry from Rutgers University.
  

• Expertise: Solid-state research, solid form screening, chiral resolution by crystallization, and nanoparticle delivery for gene therapy

Co-founder & Chief Business Officer

• 26 years of experience in pharmaceutical development, including 14 years at Merck with various leadership positions. Headed the API group - Center for Materials Science and Engineering in Merck Manufacturing Division. Established the first analytical research group in Ireland for Merck, while also maintaining direct responsibilities for overseeing the solid-state NMR facility. Obtained a Ph.D. degree in Chemistry from Pennsylvania State University

• Expertise: Solid-state NMR, drug characterization, crystallization development, IP protection; Expert witness on crystal form patent cases

Chief Financial Officer & Head of USA Site Operations

• With more than 20 years of financial management experience and rich overseas practical experience. Qualified ACCA Member since 2008. Obtained a master's degree in management from Tsinghua University

Chief Operating Officer & Head of CRO BU-Suzhou

• With over 14 years of experience in business management. Worked as Vice President of Finance at Xiaodu Technology, a subsidiary company of Baidu Group; served as Sr. Investment Director at Baidu Group. Worked for Standard Chartered Group and a couple of other well-known investment corporations in the past. Obtained a Master degree of Business Administration from Renmin University of China

Chief Technology Officer

• 18 years of pre-formulation, formulation (preclinical-III) and process development, regulatory filing and product commercialization experience at Roche, Abbott, Merck, Sunovion and Sage Therapeutics. Involved in over 35 early phase and 7 commercial products development. Skilled in various delivery systems and unit operations. Trained as Chemical Engineer (Ph.D., Univ. of Texas at Austin; BS and MS, Tsinghua University) and Pharmacometrics (MS, Univ. of Maryland at Baltimore)

• Expertise: Various delivery systems, preclinical formulation, formulation development, manufacturing unit operations and scale up

Chief Scientist

• over 30 years of experience in successfully leading pharmaceutical sciences departments and CMC project teams. She has enabled over 40 drug candidate selections, established and led the discovery support function and department for J&J, and championed several innovation initiatives such as pediatric formulation development, salt and crystal form screening and selection platforms, material science working group. Before joining Crystal Pharmatech, Dr. Huang served as the Scientific Director of Material Science and Engineering at Bristol-Myers Squibb (BMS), a member of the Scientific Advisory Board in Pharmaceutical Development, and an expert in this field. From 2010-2019, she was the Principal Investigator/Director at Celgene Corporation. Between 2002-2010, Dr. Huang was the Head of Pharmaceutical Sciences and was responsible for solid-state form/salt screening and selection for all development compounds in Johnson & Johnson US(J&J), as well as first-in-human (FIH) formulation development to support phase I and phase IIa studies. From 1993-2002, she was a technical backbone in pre-formulation research at GlaxoSmithKline (GSK).
  

• Expertise: drug candidate CMC developability assessment, solid-state form/salt screen and selection, pre-formulation and formulation development for poorly soluble drugs, discovery support and biopharmaceutical evaluations

Senior Director of R&D, CRO-Suzhou

• 7 years of solid-state research and pre-formulation development experience. Led a team to support solid-state research and crystallization for more than 200 compounds and supported the IND filing. Obtained a B.E. and a Ph.D. degree in chemistry from Tsinghua University

• Expertise: API solid-state research, crystallization development, and pre-formulation research

Head of R&D, CRO-New Jersey

• 15 years of working experience in Merck with various leadership positions including Leader of API Development Support Group - Center for Materials Science and Engineering in Merck Manufacturing Division, and Analytical Project Leader - Merck Animal Health. Obtained Ph.D. in Materials Science, Georgetown University (Studied chiral separation and crystallization in gels under Professor Jennifer Swift, Ph.D.)

• Expertise: API solid form screening/discovery, crystalline form selection, polymorphism, and chiral separations by crystallization

Chief Executive Officer, Crystal Formulation Services (CDMO BU-China)

• 24 years pharmaceutical industry experience with 22 years formulation development and CRO/CDMO/CMO vendor management experience at Merck (US) and MSD (China). Responsible for or supported over 30 new drug development, 5 of which were commercialized. Trained as Chemical Engineer at Lehigh Univ. (PhD) and Tsinghua Univ. (BS).

• Expertise: Oral solid formulation development, analytical and clinical supply

Chief Operating Officer, Crystal Formulation Services (CDMO BU-China)

• 23 years pharmaceutical industry experience in project management, QA, QC and company operation. Familiar with global GMP regulations and QMS. Chief Operation Officer of New Drug Founder’s Club. Broad management experiences in both pharma and biotech. Trained as Microbiologist at Nanjing Agriculture Univ. (BS)
  

Chief Scientific Officer, Crystal Formulation Services (CDMO BU-China)

• 21 years of Phase I-III and commercial formulation development experience at Merck (US). Involved in over 50 small molecule NCE drug product development, 15 of which were commercialized. Significant expertise on oral solid dosage, powder mechanics, dry granulation and pediatric formulation. Trained as an engineer (mechanical leaning) at Penn State Univ. (Ph.D.) and China Agricultural Univ. (BE)

• Expertise: Oral solid dosage, preclinical formulation powder mechanics, dry granulation, high shear wet granulation (HSWG) and pediatric formulation

Chief Executive Officer, Candoo Pharmatech (CDMO BU-Canada)

• 17 years of formulation development and management experience in innovative and generic pharmaceutical industries. Developed more than 30 products for global markets including First-to-Files, NCE, 505 b (2) and First-to-Markets. Ph.D. degree in Pharmaceutics and Drug Delivery from Faculty of Pharmacy, University of Toronto, Canada

• Expertise: Complex oral delivery systems, solubility/permeability enhancement, peptide delivery, bioequivalence, and alignment of nonclinical and clinical formulations for NCE drugs

Chief Scientific Officer & Head of Biologics CMC Analytical Lab
Crystal Bio Solutions

• With more than 3 decades of experiences in characterization of complex biologics with various advanced analytical techniques including analysis of proteins in various cells, tissues, blood, and related PK/PD studies using unique sample preparation techniques combined with hybrid mass spectrometry; further applied these approaches with regulatory strategies for multiple pharmaceutical companies in the US and abroad, ~80 scientific papers published in these areas. 
  

• Expertise: mass spectrometry, analytical and bioanalytical analysis of biologics

Chief Technology Officer & Head of Business Development
Crystal Bio Solutions

• Over 16 years of distinguished experience in biologics R&D. Dr. Gu has spearheaded numerous projects across Discovery, Pre-clinical, and Clinical stages of research and development. Her expertise encompasses all facets of biotherapeutics discovery and development, from hits generation and screening to candidate selection, production and advanced protein characterization. Before joining Crystal Bio, Dr. Gu held pivotal leadership positions in various biotech companies, where she oversaw process and analytical development as well as CMC operations. Before her tenure in biotech, she spent over a decade as group head, project leader and scientist in large pharmaceutical companies such as Boehringer Ingelheim and Vertex. Her portfolio spans broadly across biologics discovery, development, and CMC, with experience covering diverse biologics modalities such as antibodies, bi/tri-specifics, fusion proteins, ADCs, cell, and in vivo mRNA (-LNP) therapy.