Dipendra Gautam Phd Mb(Ascp) Email & Phone Number

Philadelphia, Pennsylvania, United States

· Serve as a subject matter expert for cell-based anti-AAV capsid neutralizing antibody (NAb) assays.· Lead the development of next-generation NAb assays (anti-capsid and anti-transgene). · Participate in assay transfers to the Translational Bioanalytics group and external CROs. · Participate in the evaluation of emerging NAb evasion technologies in.

Morrisville, North Carolina, United States

• Innovation and development of contemporary molecular/genomic and immunochemistry assays focused on CDx under Design Control (21 CFR 820), QSR and ISO:13485.
• Managed team among laboratory scientists, regulatory, quality and manufacturing for timely execution of project goal/deliverables.
• Served as a liaison between clients and the company and led meetings and scientific and project presentations/communications.
• Participated in business development meeting as an SME for new technology and business capture.
• Calculation cost modeling and Risk/Benefit analysis of projects.
• Created a coalition of internal SMEs for execution of project goals.

Greensboro/Winston-Salem, North Carolina Area

• Successfully developed laboratory derived assays (LDTs) for acute myeloid leukemia (AML) with flt3 mutations and currently the assay is live at WFBH.
• Performed qPCR-based laboratory tests for oncogenic malignancies including acute/chronic myeloid leukemia (A/CML); EGFR, KRAS, BRAF mutations; HPV screening and B-cells and T-cells clonality.
• Performed accurate and timely deliverance of results reporting, QA/QC procedures according to departmental policy, CLIA, CAP and FDA regulations.

Charlotte, North Carolina Area

• Developed homology-directed repair to create CRIPSR/Cas9 knock-in in Plasmodium falciparum to study gene regulation and splicing.
• Developed high throughput data analysis including IP-Mass spectrometry to study protein interactome in malarial parasites.
• Developed small molecule DNA damage repair inhibitors screen as a potential antimalarial drug using fluorescent based cell viability assay.

Chapel Hill, NC

• NC 2013 -2018
• Led independent research projects in studying the role of DNA damage response in the epigenetic modification of the HPV genome and its contribution toward viral gene expression.
• Worked as a team of scientists and graduate students in collaboration to contribute to research through establishing newer techniques including CRISPR/Cas9, FISH and ChIP in the lab.
• Maintained mammalian cells including primary cells and cancer cells.
• Managed laboratory through supervision and coordination of resources and expertise.

Raleigh-Durham, North Carolina Area

• Received training in FDA regulations for preparation of Investigational New Drug (IND) and Investigational Device Exemption (IDE)
• Reviewed communications with the FDA, institutional review boards (IRBs), clinical investigators and their research sites
• Studied submissions from DTMI for INDs, IDEs, IND exemption requests, IND amendments, and other communications with the FDA
• Studied the ICH-GCP, GMP, current federal regulations and FDA guidance documents.

Oxford, OH

• Investigated the role of DNA damage response mediated by ATM and ATR kinases in adenovirus infection.
• Taught and coordinated various lab and lecture courses to graduate and undergraduate level students in the field of general microbiology, clinical microbial and immunology.
• Mentored and trained 3 undergraduate students in molecular virology.

Kathmandu

Doctor Of Philosophy - Phd, Virology, Dna Damage Response, Cancer Biology

Master Of Science - Ms, Public Health