Maggie Qin Email & Phone Number | Over 18 years of experience in the biopharmaceutical industry, including in vitro diagnostics (IVD) and drug development in traditional biologics and cell & gene therapy. Technical CMC quality expertise in biologics and cell & gene therapy development. Proficient in authoring and reviewing regulatory documents such as meeting packages, IND, and BLA submissions. Strong knowledge and work experience on ICH, FDA, EMA guidelines, and guidance of analytical life cycle management, GMP QC product release, risk management, and pharmaceutical quality systems. Develop and direct strategies for analytical development to ensure that product development timelines are in place and aligned with the project’s overall objectives. Strong working knowledge and specialties in a wide range of analytical methods development, validation, and transfer; protein characterization; forced degradation and stability studies; reference material program; IVD immunoassays, protein multiplex, and quality control system. Team building and management: recruiting, leading, coaching, developing, and motivating the team to ensure delivery of the required standards of performance. Results-oriented, strong problem solving, fast learner, critical thinking & efficient, and a team player.

Maggie Qin

Over 18 years of experience in the biopharmaceutical industry, including in vitro diagnostics (IVD)...
Mississauga, Ontario, Canada

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Maggie Qin’s Location Mississauga, Ontario, Canada

Maggie Qin’s Current Industry Bluerock Therapeutics

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Quality Control Manager

2020-10-01T00:00:00.000Z - Present

Plasma Protein Analytical Group Supervisor

2016-04-01T00:00:00.000Z - 2020-10-01T00:00:00.000Z

Manager, Analytical Science

2018-09-01T00:00:00.000Z - 2020-10-01T00:00:00.000Z

Bioanalytical Assay Development and Process Development Senior Specialist

2010-02-01T00:00:00.000Z - 2015-01-01T00:00:00.000Z

Research Assistant

2009-05-01T00:00:00.000Z - 2009-10-01T00:00:00.000Z

Analytical Method Development Senior Technologist, QC& Assay Development

2007-07-01T00:00:00.000Z - 2009-04-01T00:00:00.000Z

Lab Technician

2006-01-01T00:00:00.000Z - 2007-07-01T00:00:00.000Z

Research Fellow & Lecturer

2002-07-01T00:00:00.000Z - 2004-03-01T00:00:00.000Z

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Maggie Qin is a Over 18 years of experience in the biopharmaceutical industry, including in vitro diagnostics (IVD) and drug development in traditional biologics and cell & gene therapy. Technical CMC quality expertise in biologics and cell & gene therapy development. Proficient in authoring and reviewing regulatory documents such as meeting packages, IND, and BLA submissions. Strong knowledge and work experience on ICH, FDA, EMA guidelines, and guidance of analytical life cycle management, GMP QC product release, risk management, and pharmaceutical quality systems. Develop and direct strategies for analytical development to ensure that product development timelines are in place and aligned with the project’s overall objectives. Strong working knowledge and specialties in a wide range of analytical methods development, validation, and transfer; protein characterization; forced degradation and stability studies; reference material program; IVD immunoassays, protein multiplex, and quality control system. Team building and management: recruiting, leading, coaching, developing, and motivating the team to ensure delivery of the required standards of performance. Results-oriented, strong problem solving, fast learner, critical thinking & efficient, and a team player.

Maggie Qin has prior
experience in the following industries:
Therapure Biopharma | Evolve Biologics | Sqi Diagnostics | University Of Alberta | Qsv Biologics | University Of Calgary | East China University Of Science And Technology

Maggie Qin has the following professional experience:
Bluerock Therapeutics | Therapure Biopharma | Evolve Biologics | Sqi Diagnostics | University Of Alberta | Qsv Biologics | University Of Calgary | East China University Of Science And Technology