Principal Scientist And Principal Scientist Ii resume example

• Assay development and optimization, Instrument Prototype design skills: Developed and patented Immunodiagnostics for blood typing and screening. A novel cutting-edge technology used for ABO blood typing and unexpected antibody screening and identification, leading to WW patents and development of next generation diagnostic instrumentation.
• Independently conceived, designed, and developed the feasibility of assay development and manufacturing for multiple projects.
• Identified, purified, characterized and optimized proteins and diluents and assay conditions for developing the blood typing and screening diagnostics. Optimized product design, processes and procedures and setting specifications for scaling up and manufacturing.
• Mentoring and Communication skills: Managed and supervised technical team, presented complex technical findings and conclusions

to internal and external audiences, staying current with scientific and industry literature, competitive technologies and products, promoting internal and external collaborations.

• Led and mentored several technicians with SOP and protocols drafting and execution and helped build the design and verification and validation methods assay performance on prototype instrument.
• Developed in-house SOP’s and trained junior scientists and technicians to store plasma, red blood cells and screen and identify the unexpected antibodies in plasma. Built a plasma library of rare plasmas, procuring from various blood banks across the country by networking.
• Specimen procurement and collection and Inventory Management:Proactively built a network with blood banks across the United States to procure rare plasmas and red cells for building an in-house plasma and cells library used to develop diagnostic tests. Built a strong network with hospitals in order to perform large scale, double blinded, preclinical trials.
• Procured human donor blood samples from blood banks to conduct pre-clinical trials manually in house to assess the test performance. Performed statistical analysis and analyzed complex data critically by applying advanced computer skills and identifying the source of variables in the test.
• IP and Patent identification Skills: involved in identifying the patentable aspects of the technology and bringing scientific discovery to IP team. Partnered with the legal department in drafting the patent. Highlighted the uniqueness of the test developed compared to the commercially available tests to strengthen the relevant claims, performed extensive literature and database searches to exclude any infringements.
• Quality and regulatory/ internal and external standards development and Lab safety implementation skills
• Initiated and implemented QC by design and validation principles and also cGMP processes during bulk manufacturing of disposable immunodiagnostic. Established Communication with FDA for requirements for submission.
• Led trouble shooting activities and identified the key components responsible for the quality control and repeatability and reliability of the test.
• Served as the Safety Officer, required to maintain OSHA standards at workplace, performed safety and security training for blood borne pathogens and biohazard materials specimen handling, workplace injuries filing, and biohazard and chemical hazardous materials proper handling and disposal.
• Clinical studies and External collaborations with Customers and Clinical laboratories:Performed customer surveys with blood banks for obtaining customers’ requirements [Northwestern and Uni of Chicago and Mt Sinai hospitals and physicians] for value added understanding not only from scientific perspective but also from customer need for improvising the product. Identified proper sample volumes for blood testing, applying real world use cases in order to design relevant tests.
• Conducted external COE and Clinical studies in clinical laboratories to assess the existing limits of detection on commercially available diagnostic platforms. Identified the existing limits of detection to then translate the product requirements and establish the in-house diagnostic
• . Budget and Finance decision making Skills: Managed an annual budget of $250,000 for instrumentation, involved in budget and resource planning and cost effectiveness and execution and people recruitment and LRP . Actively involved in recruitment of technicians and scientists.

Developed scientific questioning, troubleshooting, grant and scientific writing communication skills as an independent contributor, while Managing Multiple projects at OMRF & OUHSC Bioterrorism consortium as a post-doctoral trainee.

Project 1: Molecular mechanisms involved in CD4/CD8 T cell differentiation

o Identified and published novel genes and potential Transcriptional regulators in CD4/CD8 T cells lineage by differential gene expressions and studying their functional significance in the lineage decisions by dissecting the signaling pathways utilizing microarray, Real time PCR. PCR and flow cytometry techniques.

· Project 2: Role of lef-1(lymphoid enhancer 1) in CD4/CD8 T cell differentiation
Identified and Cloned genes in lck driven expression lenti viral vectors in DP cells to study role of growth factors in transcription of Hematopoietic stem cell to CD4/CD8 T cell lineage choice in Egr KO mice.

· Project 3: Mechanisms of immune tolerance: Molecular basis of T cell Anergy

o Identified and published novel signal transduction pathways essential in induction and maintenance of anergy in T cells. Studied Balb/c and transgenic mice with Staphylococcal enterotoxins induced anergy model. Functional significance of the differential gene display was studied using microarray, real time PCR, FISH, flow cytometry of surface biomarkers. This was the first study to establish the potential role of Notch and Wnt members in T cell tolerance.

· Project 4: Identification of sequential B cell epitopes of recombinant Anthrax Lethal Factor (LF) and protective antigen (PA)

o Identified and published potential vaccine targets for Anthrax, a bioterrorism agent. Identified novel B cell epitopes and studied the efficacy of the recombinant vaccine with both the LF and PA antigens in protection against anthrax.

Successfully managed multiple projects with clinical laboratories, patients and AIIMS Hospitals and worked as teaching and lab assistant to MD/MS and Medicine undergrad students and mentored Junior scientists.

· Project 1: "Expression of Co-Stimulatory Molecules in Peripheral Blood Derived Monocyte, Macrophage and T Cells from Patients Infected with Mycobacterium Leprae.” Identified and Published T-cell stimulatory and immunomodulatory molecules with cytokine profiles and surface biomarker fluorescent evaluation studies in Leprosy patients utilizing isolated PBMC's, T cell and B cell and cytokine assays.

· Project 2,3,4 Identified and published efficacious vaccine and Diagnostic candidate peptides and proteins for infectious diseases HIV, Dengue, Malaria and Plague by utilizing B and T cell solid phase epitope mapping techniques in collaboration