Jeff Guilbert
Associate Director, Imp Quality at Takeda
Based in Raynham, United States
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Seniority
Director
Department
General Business & Management
Location
Raynham
Industry
Pharmaceutical Manufacturing
Company size
37K
Contact information
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j•••••••@takeda.com
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Background
About Jeff Guilbert
20 years of GMP regulated industry experience, including biopharmaceutical, small molecule, and gene therapy programs •>20 years Quality/Regulatory Management roles with diverse quality operations and product quality experience spanning product stages from pre-clinical development through commercialization •Product quality experience for both pre-pivotal and commercial products (monoclonal antibodies, fusion proteins, gene therapy, and viral vectors) including regulatory filings, specification development, comparability, stability, method transfer, similarity and risk assessments •Extensive GMP and PAI inspection experience including FDA, EMA, PMDA, HC, ANVISA •Record of increased revenues as a result of QA Manufacturing continuous improvement •Experienced with all aspects of biopharmaceutical manufacturing including tech transfer, plant quality operations, disposition, validation, and investigations •Skilled in in product quality areas including global file authoring/RTQ’s (MAA, BLA, IND, IMPD, MF, BB), analytical comparability, product control strategy development, method transfer, and stability •Experienced with systems including Electronic batch records, NC/CAPA, Change Control, LIMS, EDL, Disposition Jurisdictional Control
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