Ying Chen Email & Phone Number | An experienced, progressive thinking quality professional with experience in Pharmaceutical/Biotechnology/Medical Device industries. A certified Quality Assurance, Quality Control and Regulatory professional with broad range experience in Quality Assurance (Quality System), Quality Control, project management, analytical method development, CMC and regulatory compliances in cGMP/GLP/GCP research and manufacture environment. Knowledgeable of CDER, CBER, ISO, JP and EU requirements. Experienced in FDA/ISO/EU audits, A dynamic result driven leader with exceptional leadership skills in planning, recruiting, coaching, developing, and motivating staffs. Familiar with analytical and microbiological methodologies of various drug substance and drug products. Hands-on in depth knowledge of environmental monitoring of aseptic manufacture environment in support of commercial manufacture of solid doses, injectables and medical devices . Consistent success in achieving target revenue, effective productivity and operational excellence. Core Competencies: • New Project Design/Development • Analytical Methods Development/Validation • API / Drug Product Stability Studies • Small Molecule, iRNA, protein and Antibody Research • Analytical methods of HPLC and GC with various detectors, Dissolution, FTIR, DSC, Particle Analysis, ELISA, SDS-PAGE, iCIEF and Spectroscopy • Operation of HPLC, GC. LC/MS, LC/MS/MS and other diverse lab equipments • Aseptic Manufacture and Environmental Monitoring • Medical Device Product Sterilization • Document Control • Raw Material, Intermediate Product and Finished product Inspection • New Equipment IQ, OQ, PQ and Validation • Project Planning and Scheduling • Budget Planning and Administration • QA / QS / QC Audits • Change Control / Complaints / CAPA, OOS, NCR and Deviations • Process Improvement with LSFM or Lean Six Sigma

Ying Chen

An experienced, progressive thinking quality professional with experience in Pharmaceutical/Biotechn...
San Diego, California, United States

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Ying Chen’s Email yingchen@qilupharma.com

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Ying Chen’s Location San Diego, California, United States

Ying Chen’s Current Industry Wuxi Xdc

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Work Experience

Wuxi Xdc

Vice President Global Quality Head

2024-08-01T00:00:00.000Z - Present

Remegen Biosciences

Vice President, Global Quality Operations

2023-04-01T00:00:00.000Z - 2024-08-01T00:00:00.000Z

Qilu Pharmaceuticals

Senior Director of Quality and Compliance, Biologic

2021-01-01T00:00:00.000Z - 2023-04-01T00:00:00.000Z

Bristol Myers Squibb

Sr. Manager of Quality Control Operation

2013-08-01T00:00:00.000Z - 2016-07-01T00:00:00.000Z

Suneva Medical

Associate Director of Quality Control

2010-08-01T00:00:00.000Z - 2013-08-01T00:00:00.000Z

Catalent Pharma Solutions

Manager/Project Director of Quality Control and Stability

2005-01-01T00:00:00.000Z - 2010-06-01T00:00:00.000Z

Cardinal Health

Group Leader of Analytical Development and Method Validation

2003-01-01T00:00:00.000Z - 2005-01-01T00:00:00.000Z

Iqvia

Senior Associate Specialist of ADME and Biopharmaceutical

1999-04-01T00:00:00.000Z - 2001-07-01T00:00:00.000Z

Covance

Supervisor of Analytical Chemistry

1993-01-01T00:00:00.000Z - 1999-01-01T00:00:00.000Z

Skills

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Languages

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FAQ About Ying Chen

Ying Chen is located at
San Diego, California, United States

Ying Chen is a An experienced, progressive thinking quality professional with experience in Pharmaceutical/Biotechnology/Medical Device industries. A certified Quality Assurance, Quality Control and Regulatory professional with broad range experience in Quality Assurance (Quality System), Quality Control, project management, analytical method development, CMC and regulatory compliances in cGMP/GLP/GCP research and manufacture environment. Knowledgeable of CDER, CBER, ISO, JP and EU requirements. Experienced in FDA/ISO/EU audits, A dynamic result driven leader with exceptional leadership skills in planning, recruiting, coaching, developing, and motivating staffs. Familiar with analytical and microbiological methodologies of various drug substance and drug products. Hands-on in depth knowledge of environmental monitoring of aseptic manufacture environment in support of commercial manufacture of solid doses, injectables and medical devices . Consistent success in achieving target revenue, effective productivity and operational excellence. Core Competencies: • New Project Design/Development • Analytical Methods Development/Validation • API / Drug Product Stability Studies • Small Molecule, iRNA, protein and Antibody Research • Analytical methods of HPLC and GC with various detectors, Dissolution, FTIR, DSC, Particle Analysis, ELISA, SDS-PAGE, iCIEF and Spectroscopy • Operation of HPLC, GC. LC/MS, LC/MS/MS and other diverse lab equipments • Aseptic Manufacture and Environmental Monitoring • Medical Device Product Sterilization • Document Control • Raw Material, Intermediate Product and Finished product Inspection • New Equipment IQ, OQ, PQ and Validation • Project Planning and Scheduling • Budget Planning and Administration • QA / QS / QC Audits • Change Control / Complaints / CAPA, OOS, NCR and Deviations • Process Improvement with LSFM or Lean Six Sigma

Ying Chen currently works in the Wuxi Xdc |

No Languages Available

Ying Chen has prior
experience in the following industries:
Remegen Biosciences | Qilu Pharmaceuticals | Bristol Myers Squibb | Suneva Medical | Catalent Pharma Solutions | Cardinal Health | Iqvia | Covance

Ying Chen has the following professional experience:
Wuxi Xdc | Remegen Biosciences | Qilu Pharmaceuticals | Bristol Myers Squibb | Suneva Medical | Catalent Pharma Solutions | Cardinal Health | Iqvia | Covance