Ayan Dey
Senior Manager Process and Analytical Development @MilliporeSigma
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WORK HISTORY
Senior Manager Process and Analytical Development @MilliporeSigma
Carlsbad, CA, US
Senior Manager, Process and Analytical Development for Viral Vectors, Cell and Gene Therapy• Serving as a key scientific and technical representative for Upstream process and analytical methods at internal sites, meetings, and with external partners• Led a diverse team of scientists in the technical R&D laboratory to deliver processes in support of new pipeline for Adenovirus, AAV and Lentivirus vector cell & gene therapies.• Utilize an advanced DOE-based approach for developing robust processes.• Builds and maintains a high-performing staff of scientists to support ongoing process and pipeline development as well as process transfers to internal and external sites• Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes & methods.• Supports and develops the next-generation manufacturing processes by planning to avoid delays, managing resources, and leading activities to deliver a robust and effective product and process.• Leads development and fit-for purpose qualification of bio and molecular assays including transduction, FFU assay, TCID50 assay, FACS based potency assay, mRNA Expression, RCA Assay, ELISA based p24, p30, capsid title assay and reporter gene assay, dd-PCR and qPCR based assays.• Tech transfer of analytical methods to QC and support qualification & validation.• Reviews and provides feedback and technical/scientific support on project deliverables,(e.g. remediation initiatives, plan reports)• Ensures all documentation and reports are accurate, complete, and suitable for use in support of the development, characterization, and regulatory approval of products• Partners with Project Managers, Strategy Teams, Engineering, Supply Chain and others to anticipate and plan for budget and capex cycles, human and materials resources.
EDUCATION
Delhi University
B Sc (Microbiology), Microbiology
All India Institute of Medical Sciences
Ph. D, Immunology & Molecular Biology
Delhi University
Masters, Microbiology
SKILLS
ABOUT AYAN DEY
Expert Professional with 15.0 + years of experience in the Vaccines and Viral Vectors Cell and Gene therapy space. Working as CMC and analytical Lead for vaccine, Cell & Gene therapies product development and global health projects with experience in• Vaccines discovery, upstream and downstream processes, drug substance and drug product manufacturing under cGMP condition, immunoassays and analytical development and validation per GLP requirements.• CMC Lead for Viral Vaccines and Viral Vector Cell and Gene Therapy Process Development from Bench to Manufacturing Process (End to End)• Project Leader for World First Licensed DNA Vaccine ZyCoV-D® against COVID-19• Lead for development of mRNA based Covid-19 and Rabies vaccine, Hepatitis A, Chikungunya, Cell Based Influenza, Vero based Rabies, MMR and MMRV Vaccines• Lead on technology development for Inactivated, Live Attenuated, Baculovirus expression based and VLP based vaccine candidates.• Lead for Analytical and Immunoassays Development for vaccines with strict GLP and GCLP compliance.• Lead for Process Technology transfer to GMP, scale-up, Risk Assessment and life cycle management.• Experience managing high potential pool of senior scientist, scientist, specialists with 10+ years of people management experience.• Managing and leading research projects funded by CDMO Clients, BMGF, the Korea Government and Indian Government, Gates Foundation, Korean National research Foundation, Department of Biotechnology, Government of India• Achievements including patent and publications on preclinical and clinical evaluation of vaccines in peer reviewed journals such as The Lancet, Nature Protocols, Vaccine, Clinical Infectious Disease and Plos One• Reviewer for peer reviewed journal including Vaccine and Plos One
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