Advisory Committee Member Profile
Shen Chen
Alcami
Senior Director |
Areas of Expertise
Customer Experience Strategy, Customer-Focused Innovation, Customer First Culture, Principles of Customer Relationship Building, Customer Experience Functional Alignment
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Dr. Shen Chen is a Sr. Director in Alcami Corporation who leads the Analytical Research and Development function from multiple sites for product development, including API, oral solid doses, and sterile injectables. Prior to Alcami, Dr. Shen Chen was the Director of Pfizer Essential Health, Pharmaceutical Science. Her main responsibility was to lead R&D functions for Pfizer CentreOne, a global CMO embedded within Pfizer.
Her team was focused on tasks which included solving technical challenges from those associated with fill-finish product development, late phase development and technical transfer, to the manufacturing of sterile injectables. She has more than 20 years of experience in Pharmaceutical R&D with sterile injectable development and manufacturing scale-ups. In recent years, her team helped its partners launch nearly 10 products. Previously, Shen held various technical leadership positions in the legacy Hospira Global R&D. Most recently, prior to her position with PC1 R&D, she was the R&D Director for Product and Plant Supports. In this position, she supported life cycle management activities for all US marketed products for legacy Hospira, including market expansions, API changes, line extensions, and registration for grandfathered products. Her team provided technical support for troubleshooting of manufacturing, process improvements, drug shortages, and warning letter-associated remediation activities occurring at different manufacturing sites to fulfill FDA commitments. She also led the legacy Hospira R&D generic group for generic injectable developments, including obtaining approval and launching of many injectable products in global markets.
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