Dr. Nikita Singh
Preclinical Development Manager @ AATec Medical
About
Passionate and results-driven research scientist with extensive expertise in Hematology-Oncology, radiation biology, and Pharmacokinetics/Pharmacodynamics (PK/PD) studies, specializing in designing, planning, and managing nonclinical in vivo studies (rodents, rabbits, and minipig models) and in vitro research. Proficient in aligning nonclinical programs with regulatory strategies, contributing to key regulatory submissions such as IBs, Pre-INDs, and IND briefing package for FDA and EMA. Adept at leading complex projects with strict adherence to quality, timelines, and budgets, ensuring consistently successful outcomes. Skilled in creating development plans, protocols, and reports while providing comprehensive guidance to international study centers to achieve the highest standards of execution. A forward-thinking scientist dedicated to translating innovative research into impactful regulatory and clinical applications, driving collaboration and advancing science with precision and excellence.
Germany
Munich
Research
Skilled Multi-tasker, Project Delivery, Immunostaining, Outcomes Research, Market Analysis, Adobe Illustrator, Interdisciplinary Teaching, Cross-functional Team Leadership, Relationship Building, Troubleshooting, Histopathology, Immunoassays, Protein Purification, Protein Characterization, Mammalian Cell Culture, Antibodies, Laboratory Management, Regulatory Guidelines, Regulatory Affairs, Experimental Design
Experience

Scientist
Berlin, Germany
● Independently designed, planned, monitored, and reported nonclinical in vivo (rodents, rabbits and minipig animal model) and, to a lesser extent, in vitro studies in the field of acute radiation syndrome and radionuclide research. ● Proactively managed projects, ensuring strict adherence to quality standards, timelines, and budget targets, resulting in consistently successful outcomes. ● Contributing to the creation of development plans, study protocols, reports, supporting documents, regulatory submissions, and ethical applications ● Provided comprehensive supervision and guidance to study centers at an international level, both remotely and in-person, effectively driving their performance and ensuring the highest standards of execution. ● Aligned the non-clinical program with regulatory strategy and incorporating project-relevant nonclinical data into regulatory documents such as IB, Pre-IND, and IND briefing book for FDA and EMA interactions.

Doctoral Student
Berlin Area, Germany
Developed extensive experience in range of molecular, immunological and cellular techniques. ● Molecular biology: Cloning, PCR, RT-qPCR, Transformation, cDNA synthesis, DNA/RNA isolation, CRISPR/Cas9 technique. ● Cell culture: Primary cells, mammalian and murine cell lines, co-cultures. ● Protein Isolation and quantification (Co-IP, SDS-PAGE and western blot). ● Immunology: Flow cytometery, ELISA, Immuno-electrophoresis, cell cycle and proliferation assay, Apoptosis assay, Immunohostochemistry (IHC). ● In-vivo: Mouse model, FELASA B certification, i.p. and i.v. injections. ● Software: MS office, Inkscape, Flowjo, Prism, Endnote. Data interpretation and visualization. Concise communication skills with experience in meticulous scientific data presentation and database search. ● Gained skills in generating robust and reliable data, ensuring studies and results were in compliance with the respective protocol.

Student Research Assistant
Institut für Allgemeine Botanik und Pflanzenphysiologie
Jena Area, Germany
Functional characterisation of C3 subunit in Chlamydomonas reinhardtii: ● Molecular cloning (PCR, qPCR, Restriction analysis, Ligation, Transformation, DNA/RNA isolation) ● Chloroplast isolation ● Protein isolation and quantification (Co-IP and western blot) ● Basic bioinformatics ● Microbiology techniques ● Immunology techniques (ELISA, Immuno-electrophoresis)

Associate- Retail process
Worked on promotions in different market. -Responsible for sales monitoring/tracking and price refreshes directly on the amazon website. -Helped in building a tool which reduced the number of team strength. -Responsible to monitor and ensure the accuracy of the pricing analytics team through audits and process improvement activities -Perform other duties as assigned, including ad-hoc analysis on methods to optimize price through market and pricing strategies. - In coordination with project managers, prepare projections of revenue and expenses for projects based on numerous variables and data assumptions. -Take initiative in identifying and resolving issues around pricing and how to effectively improve the process to be more competitive in the market. - Monitor, analyze, and report on weekly, monthly and yearly basis for Price Realization, selection and availability in market versus various competitor.
Dr. Nikita Singh's Contact Information
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