Mayukh Das Email & Phone Number

Houston, Texas, US

Raritan, New Jersey, US

• Efficient People’s manager along with scientific and management leader of multiple cross-functional projects in Drug Discovery and Pre-clinical/Clinical Development of infectious diseases.
• Developing large molecule complex biological drugs (genetically modified virus) as NME (New Molecular Entity), by preclinical experimentation, in-vitro assay development with or without SoC (Standard of Care).
• Strongly and actively supporting post-NME activities including FDA (Briefing Book, IND, NDA) and EMA regulatory submission, CMC process development and quality operations, pre-clinical safety (toxicology – FDA, ICH).
• Efficiently optimized and validated microbiology test methods based on global regulatory standards (CLIA, FDA), transferred to CRO and ensured clinical practice guidelines (CLSI, EUCAST) to support GxP compliant.

Austin, Texas, US

• Involved to develop rapid in vitro clinical diagnosis (IVD) of bacterial ID and antibiotic (Small molecule) susceptibilities for clinical respiratory pathogens using single-cell digital culture technology to fight.
• Successfully developed and optimized Resorufin-based electrochemiluminescence (ECL) signal detection multiplex assay in MesoScale Discovery (MSD) platform to analyze a range of small molecules as substrates for.
• Generated the development plan including manufacturing based on FDA regulatory guidelines.

College Station, TX, US

• Conducted cell and gene therapy clinical research. Successfully developed new stable recombinant human cell lines using lentiviral vector gene editing system (viral vector engineering) through extensive hands-on work.
• Small scale production of recombinant lentivirus, quantification of viral vector.
• Excellent leadership, management and high-level strategic planning to drive cross-functional teams and leading by influence to develop and ensure successful execution demonstrated for team working in DARPA funded.
• The approach successfully established a phenotype-based (virulence, toxicity, innate immune response) ML pipeline for potential pathogenic threat assessment with previously machine-observed and unobserved bacteria with.

Cupertino, CA, US

• Excellent teamwork, strong leadership and decision-making skills demonstrated to design (statistically validated), set up, conduct, recruitment activities, closeout, and reporting results with statistical validation of.

College Station, TX, US

• Strong communication and management skills demonstrated by successful completion of multi-site field trials, statistical analysis using R software. Efficiently led Process Development (upstream and downstream.
• Evaluated new bacteriology targets, therapeutic concepts, and therapeutic agents (Peptides/Proteins). Managed a team of high-performance scientists. Supported the evaluation of external licensing opportunities..

College Station, TX, US

• Outstanding project leader who facilitated the completion of multi-institutional collaborative Otsuka Pharmaceutical funded R&D project to develop biological to control Pierce's Disease by leading a team of.
• Analyzed and interpreted complex data sets, interconnecting results from molecular and microbiology assays, resulting in significant findings on discovery of first virulent Xylella phages, genomic sequencing using NGS.
• Demonstrated ability to function in an interdisciplinary team setting, having worked closely with 5+ cross-functional experts and successfully trained personnel during the tech transfer of assays from R&D to GMP.

IN

■ Involved on development of stable and cost-effective DNA vaccines for silencing genes of White Spot Syndrome Virus in Penaeus monodon through RNA interference (RNAi).

• Efficiently worked as team member in WHO recognized Collaborative Center for Research and Training on Diarrhoeal Diseases to routinely evaluate (IVD) clinical samples and prepared reports.
• Successfully managed five multi-faceted projects simultaneously by strong problem solving and analytical skills as evidenced by nine publications and five conference proceedings.
• Independently developed a protocol for whole genome sequencing of first typing vibriophage and phenotypic and molecular profiling of clinical Vibrio cholerae isolates, surveillance using Multiplex-PCR, demonstrated.
• Demonstrated strong scientific and creative knowledge by designing and accomplishing experiments resulted remarkable in vivo therapeutic efficacy of vibriophages against experimental cholera.
• Actively involved in cholera vaccine trial program and multiple outbreak investigation conducted by NICED in India by handling and evaluating clinical samples.

Doctor Of Philosophy - Phd, Life Sciences (Molecular Microbiology)

Master Of Science - Ms, Botany

Bachelor Of Science (Bsc), Botany

Higher Secondary, 1996, Higher Secondary, Science