Maggie Qin
Senior Manager, Stability, Raw Material & Qms, Cgt Analytical Ops & Qc @Novartis
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WORK HISTORY
Senior Manager, Stability, Raw Material & Qms, Cgt Analytical Ops & Qc @Novartis
East Hanover, NJ, US
EDUCATION
Shandong University
B.Sc, Microbiology
University of Toronto
Management Essential Program
Shandong University
M.Sc, Biochemistry
SKILLS
ABOUT MAGGIE QIN
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/analytical 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.
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