Maggie Qin Email and Phone Number
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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.
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Quality Control ManagerBluerock Therapeutics Oct 2020 - PresentCambridge, Massachusetts, UsAnalytical CMC strategies, product quality oversight, and author regulatory document section analytical sections.QC GMP manufacturing support and testing activities for samples generated to support the release and compliance of cell therapies destined for human clinical trials. QC specifications include raw materials testing, in-process testing, and release testing of cell banks and cell therapies.GMP facility EM program, cleanroom release and environmental monitoring (EMPQ) protocol, data and reports.Method transfer, qualification, and validation studies for QC test methods and/or characterization assays, including the establishment of reference material, in a clinical phase-appropriate manner.QC laboratory operations, equipment validation and maintenance, sample management, test reporting, and materials inventory.Product CoA issue, OOS, Deviations, and Failure Investigations management.CRO, CDMO, external testing labs coordination and management.
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Manager, Analytical ScienceEvolve Biologics Sep 2018 - Oct 2020Mississauga, Ontario, Caa) Manage an analytical science team for analytical development and analytical testing service, and ensure the delivery of group and individual objectives.b) Lead method development, qualification, validation and assay performance monitoring according to ICH guidelines and FDA guidance. c) Oversee and coordinate activities in outsourced analytical labs, CMOs, CROs, CLOs. Provide technical expertise of assay validation and performance trending, OOS, OOT, assay failure investigation, and assay improvement activities, including drug release assays and bioanalytical assays for PK/TK studies in clinical trials.d) Managing CMC-related activities: product characterization and comparability studies, reference standard qualification, and stability programs. e) Review discrepancy management, technical change management and CAPA management document associated with contract organizations for routine GMP release. -
Plasma Protein Analytical Group SupervisorTherapure Biopharma Inc Apr 2016 - Oct 2020Mississauga, Ontario, Ca -
Biochemistry Method Development SpecialistTherapure Biopharma Inc Jan 2015 - Mar 2016Mississauga, Ontario, Ca
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Bioanalytical Assay Development And Process Development Senior SpecialistSqi Diagnostics Feb 2010 - Jan 2015Toronto, On, Ca -
Research AssistantUniversity Of Alberta May 2009 - Oct 2009Edmonton, Ab, Ca -
Analytical Method Development Senior Technologist, Qc& Assay DevelopmentQsv Biologics Jul 2007 - Apr 2009Edmonton, Alberta, Ca -
Lab TechnicianUniversity Of Calgary Jan 2006 - Jul 2007
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Research Fellow & LecturerEast China University Of Science & Technology Jul 2002 - Mar 2004
Maggie Qin Skills
Maggie Qin Education Details
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Shandong UniversityBiochemistry -
Shandong UniversityMicrobiology
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University Of TorontoManagement Essential Program
Frequently Asked Questions about Maggie Qin
What company does Maggie Qin work for?
Maggie Qin works for Bluerock Therapeutics
What is Maggie Qin's role at the current company?
Maggie Qin's current role is Product Quality, Analytical CMC & QC, Cell & Gene Therapy.
What is Maggie Qin's email address?
Maggie Qin's email address is mq****@****bio.com
What is Maggie Qin's direct phone number?
Maggie Qin's direct phone number is (905) 286*****
What schools did Maggie Qin attend?
Maggie Qin attended Shandong University, Shandong University, University Of Toronto.
What skills is Maggie Qin known for?
Maggie Qin has skills like Elisa, Protein Chemistry, Biochemistry, Hplc, Assay Development, Gmp, Fda, Sds Page, Sop, Protein Purification, Western Blotting, Validation.
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