Winston Umakanth B
Director - Quality Control @Inventprise
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WORK HISTORY
Director - Quality Control @Inventprise
Redmond, WA, US
Head of Quality Control (Bacterial and Viral Vaccines) for clinical and commercial products, including management of in-process, release and characterization testing of GMP products. Accountable for the development and lifecycle management of the QC laboratory operations, including but not limited to sample management, in-process, release and stability testing, laboratory equipment maintenance, data trending, laboratory investigations, execution of method validation and stability studies. Responsible for stability testing and Drug Substance (DS)/Drug Product (DP) release and for all analytical activities. Accountable for ensuring adherence to strict regulatory requirements to ensure product quality. Support the development and management of QC specifications for in-process, release and stability testing programs. Establishes requirements and develops on-the-job-training plans for the QC team. Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures. Responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. Support the site for all internal and external audits and regulatory quality inspections.
EDUCATION
University of Madras
Bachelor of Science (B.Sc.), MICROBIOLOGY
Sikkim Manipal University - Distance Education
Master of Business Administration (MBA), Total Quality Management (TQM)
Periyar University
Master of Science (M.Sc.), MICROBIOLOGY, University Gold Medallist
ABOUT WINSTON UMAKANTH B
A highly motivated and competent Team Leader with strong vision to achieve successful outcomes on time and with excellence. Adapted good leadership skills involving planning, developing, standardizing and carrying out experiments with strong analytical and problem solving skills. Having over 21 years of experience in the field of Vaccines and setting up systems for quality operations. Key skills are in developing, standardizing and validation of analytical methods. Setting up systems analytical tools, implementation of quality systems, management of projects, method development, qualification, validation, technology transfer and regulatory submissions including investigational new drugs (INDs) and new drug applications (NDAs).
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