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Project Data Entry

Location:
Tampa, FL
Posted:
June 10, 2017

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Resume:

ac0scj@r.postjobfree.com

336-***-****

ROHINI RAYAN

PROFILE • 5 years of experience in molecular biology and cell culture techniques.

• Specialized in development of genetically modified stable stem cell lines and mammalian cell lines; primary cell isolation & characterization.

• Consistently managed relationships within the team and their expectations to achieve results.

• Strong planner and organizer; adept in implementing newly mastered concepts.

• Facilitate solutions to the projects to escalate any risk/issue; effectively communicate to the project teams and leads.

PROFESSIONAL

ACHIEVEMENTS

PRIMARY CELL ISOLATIONS

• Worked in a client-based research service providing custom cell line products isolated from animal

&human tissues.

• Successfully delivered 0n-demand cell lines – Mesenchymal stem cells, Peripheral blood mononuclear cells, porcine and feline kidney cells.

GENE EDITING USING ZINC FINGER/TALEN/CRISPR TECHNOLOGY AND STEM CELL CULTURE

• Stable cell line generation in human embryonic stem cell line using ZFN/Talen/Crispr technology.

• Successfully generated stable cell lines in HEKS, CHOs, and Tet-dependent cell systems.

• Carried out gene editing projects confirming the quality and quantity using qPCR, sequence analysis, copy caller and SNP analysis.

GENOTYPING AND QPCR

• Designed SNP Taqman protocols (SOP) for identification of SNP genes in human DNA.

• Generated qPCR sops for gene quantification of BCRZ gene present in salivary glands of drosophila. WORK HISTORY DATA PROCESSING SPECIALIST, FDA (CONTRACTOR – PART TIME), COLLEGE PARK, MD. FEB 2016- SEPT 2016

• Data entry and creation of new reports of all infant formula notifications into the FDA database application- IFTRACK and CLINTRACK.

• Control all infant formula notifications, subject files, and company files in cooperation with any other contractors controlling infant formula records.

• Maintain a weekly back-up copy of IFTRACK for reviewer use.

• Document any changes to the infant formula databases and documents.

• Help troubleshoot any database problems; Correction of any errors made during the maintenance and management of infant formula records whether current or past.

• Complete any backlog of infant formula records tasks as needed.

• Monthly reports to include list of new infant formula notification projects, new subject or company files created, new CLINTRACK projects, and infant formula records’ corrections, and backlog RESEARCH ASSOCIATE, LONZA, WALKERSVILLE, MD. NOV 2014- MAY 2015

• Led projects with minimum supervision- Initiate, conduct literature search on feasibility, isolation process and develop antibody panel for cell characterization for specific cell type.

• Plan sessions with key stakeholders to strategize outcomes to meet product requirements.

• Design the cell isolation process (DOE), Collaborate across different R&D units to achieve the technical training required for execution of projects – trained on flow cytometry.

• Facilitated weekly meetings with senior management to provide an update on project status and escalate any issues/risks.

• Reviewed project deliverables and products for quality and ensured they were delivered on time; prioritized multiple assignments to ensure client received exceptional support when needed. Page 2 ROHINI RAYAN

MOLECULAR BIOLOGIST, PFIZER, GROTON, CT. SEPT 2012- MAY 2014

• Worked in a cross-functional team performing cell culture duties; applied molecular techniques to assess the stably transfected cell lines.

• Led the editing projects; tested and analyzed product outcomes confirming quality and quantity (using qPCR, sequence analysis, copy caller and SNP analysis).

• Gathered, analyzed, documented, and validated product requirements by adhering to standard protocols and successfully reproduced accurate data.

• Basic Cloning- E. coli transformation/culture/plasmid DNA isolation, maintain glycerol and DNA stocks, archiving into Pfizer Vector library database (CVP). RESEARCH TECH, CENTER FOR BIOTECH, GENOMICS AND HELATH RESEARCH, GREENSBORO, NC. OCT 2011- JULY 2012.

• Project 1: Generated qPCR data supporting the presence of SNPs that were identified in Human genome associated with susceptibility to noise-induced Hearing loss.

• Project 2: Designed qPCR procedure to quantify the expression of BCRZ gene in salivary larval glands of drosophila induced by 20-Hydroxyecdysome receptor (20E), an essential modulator of the physiological functions in larval glands.

EDUCATION REGULATORY AFFAIRS CERTIFICATE: PHARMACEUTICALS, ONLINE, 2017. RAPS ORGANIZATION

• Intermediate Medical Writing: Biologics and Pharmaceuticals – applications for new medicinal, drug and biologics products (NDA, BLA an MAA)

• Intermediate Medical Writing: Investigational Applications seeking clinical trials for new drugs/biologics in the US, CANADA, EU and other global markets (IND, CTA, IMPD, IDE, EU CTA and ITA).

• US Clinical Trials: foundation of clinical trials; CFR related to clinical trials; clinical trial structure, maintenance and monitoring; clinical trial data.

• Chemistry, Manufacturing and Controls (CMC): CMC information required for new drugs/biologics to support clinical studies and marketing applications. MASTER OF SCIENCE IN BIOCHEMISTRY, JULY 2011.

UNIVERSITY OF NORTH CAROLINA AT GREENSBORO, GREENSBORO, NC. Thesis: Cloning and characterization of frameshifting site in gag gene of HIV

• Techniques: Basic molecular biology- PCR, Gel Electrophoresis, cloning, site directed mutagenesis, sequence analysis, transient transfection in jurkats, hek Cell line. Routine culture and expansion. Measured frameshifting efficiency using dual –reporter luciferase assay.

• Instructed undergrad chemistry and biology labs for 3 years. BACHELOR OF SCIENCE IN BIOCHEMISTRY, APRIL 2008.

OSMANIA UNIVERSITY, HYDERABAD, INDIA.

Under graduate research title - Quantitative structural Activity Relationships (QSAR) on 2-Amino 5-Substituded Pyrimidine Inhibitors (Anticancer Agents).

• Comparative molecular field analysis (COMFA) to study structural aspects of 46 compounds.

• Performed comparative molecular similarity indices analysis (COMSIA).

• Conducted 3D QSAR studies on all 46 compounds on sybyl 6.7 software.



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