Dr. Claudia Lin, Owner & CEO

Background and Experience

From China to US and back to China, Dr. Lin is a true international expert, who is passionate to contribute to the advancement of biopharmaceutical development in China and beyond.


Dr. Lin has had a successful career in the global stage with a unique coverage from R&D to product development, and to commercial product operations. 


Whether you are just beginning to plan your clinical production, or have the new ambition of taking your product from China to global; whether you realize that to move into late stage clinical development, you need a complete make-over of your Quality systems, or it's time to file for BLA, we will have your Quality needs covered. 


Ph.D. - University of California, Berkeley, CA

Cell and Molecular Biology–Breast tissue development & malignant transformation


Postdoc - Howard Hughes Medical Institute, UCLA, CA 

Biochemical research of differentiation in nervous system. 


Postdoc - Lawrence Berkeley National Laboratory, CA

Malignant mechanism of breast cancer. 


Scientist - Berlex Biosciences/Shering AG, CA

Early stage R&D in anticancer drugs.


Sr. Scientist/Manager - Exelixis Inc., CA

Preclinical and phase I biomarker, methodology research, development, validation, and testing in anticancer drugs. 


Associate Director - Geron Corporation – Bioanalytical testing, CA

Bioanalytical testing technology development, validation, GLP, GMP, GCP tests.


Associate Director - Genentech, CA

Head of QA & QC for products in clinical development.


Associate Director - Genentech, CA

Commercial QC, global technology transfers, annual product quality review. 


Director, QP - Bayer Healthcare, Berkeley, CA

Head of QA, leading all quality assurance for all biological products in all development phases. 


VP/Sr. VP Innovent Biologics, China Head of quality, compliance, and commercialization.

image1

David Kapitula, Chief Operating Officer

Background and Experience

科学硕士 MS, Albert Einstein College of Medicine

Molecular Biology of Spinal Cord


技术管理硕士 MBA, Uni of Penn, Wharton School of Business

Engineering and Business Management


QC Manager, V.I. Technologies, Inc., New York, Run the facility and operation of a molecular biology contract laboratory


Director, Quality Control, Imclone Systems Incorporated, New Jersey

Commercial and clinical QC biochemistry operations for Mab.

Director, Contract Manufacturing

Imclone Systems Incorporated, New Jersey

Provide management of external GMP partner relations.


Sr. Director, Quality Control, Cell Genesys Incorporated, Hayward, California, Direct clinical QC operations for biotechnology manufacture.


Director, Quality Assurance

Bayer Healthcare, Berkeley, California(拜耳)Direct commercial QA operations for Hemophilia products.


Director, Quality, ROCHE/Genentech, Singapore (罗氏)Direct Quality management of biotechnology products.


VP, SVP of Quality and Operations

JHL, Taiwan and China (喜康)Full operational responsibilities for KuBio facility qualification and product manufacturing


Founder/VP of Quality and Regulatory Affairs, CMAB, Suzhou, China (苏桥)

Responsible for the concept to facility, system. Team  building.


Chief Operating Officer

Jade Biomedical (驾玉生物医药行业)

Responsible for the technical, financial operation and business development.

image2