Manasa Peddineni

E-mail: acvpbw@r.postjobfree.com . M: 408-***-****. San Francisco, CA

https://www.linkedin.com/in/manasa-peddineni-a71756b4

SUMMARY:

Scientist with over 4 years of working experience in research, manufacturing, quality control and Next Generation Sequencing with hands on experience working with equipment used in the pharmaceutical / biotechnology industry.

Knowledge and experience of ensuring FDA compliance of 21 CFR Part 11and 211 and cGxP (GMP, GCP, GLP) standards. Skilled in developing SOP’s, policies and work instructions.

Excellent communication, writing and interpersonal skills and strong ability to perform individually and also as part of a team.

TECHNICAL SKILLS:

Quality – 21 CFR Part 11 (210/211, 820), cGMP, GDP, GLP, SOPs, Clean room practices, Validation reports

Business Tools – MS Office (Word, Excel, Power Point), Documentum, Agile, Track wise, LIMS, JMP, SAS

Operating Systems – Windows NT/95/98/2000/XP/Vista/7/10

NGS skills - DNA templating,TF production, Sample preparation, Reagent preparation, Next Generation Sequencing on various Ion Torrent Platforms such as OT-2, CHEF, PGM and Proton’s

WORK EXPERIENCE:

Thermo fisher Scientific May 2015- present

Associate scientist II

Manufacturing and quality control of the Ion sphere particles following the SOP’s and GMP

Performed assay development, stability studies including water titration studies.

Next Generation Sequencing on Ion Torrent Platforms.

NGS sample and reagent preparations

Production and quality analysis of reagents, components and finished products.

Performed filtration using Tangential flow filtration.

Performed Templating, PCR, qPCR, DNA amplification, FAM-B assay, HYBE assay, carboxy assay, cell counting etc.

Participated in troubleshooting and variable identification for specific processes or activities

Ensured the traceability of each lot through documentation

Maintained equipment, product inventories and related records as assigned.

Reported findings to members of functional and cross functional teams with recommendations for improvement

Performed final product handling of the liquids including diluting, packaging and shipping.

Performed analysis using instruments such as GUAVA flow cytometer, spectrophotometer, fluorescence microscope etc.

Prepared Technical reports, Summaries, Protocols and validation reports and GMP batchrecords

Fairleigh Dickinson University March 2013-Dec 2014

Research assistant

Developed Nano chitosan from chitosan by ionic gelation method

Encapsulated Nano chitosan nanoparticles with Nisin, and β-acids such as Lupulone and Xanthohumol

Performed analysis of β-acids and HOP extracts using HPLC, UV and IR spectrophotometer

Performed assays such as anti-oxidant, immuno and microbial assay’s to establish the chemical properties of the nanoparticles.

Performed kinetic studies and microbiological studies to determine the bioavailability invitro and minimum inhibitory concentrations of the nanoparticles

Calibrated equipment in the laboratory like pH meter, thermometers, UV spectrophotometer, dissolution apparatus

Presented findings to New York Society for Cosmetic Chemists and Hudson-Bergen Chemical society

Matrix Pharmaceuticals Jan 2012- Dec 2012

Process development scientist

Analyzed biological samples for quantitative measure of pharmaceutical compounds

Refined the existing processes to optimize the manufacturing process

Validated new processes to prove they are an improvement

Follow validated and experimental analytical procedures ( HPLC and LC/MS)

Performed analytical tests for Drug Release, Content Uniformity, Impurities and Degradation Products

Responsible for ensuring the compliance of GMP/GLP and FDA regulations

Divis Pharmaceuticals Feb 2011 – Dec 2011

Chemist/ QC

Analyzed bulk, finished, and stability product samples

Handled liquid dosage forms and determined the quality of the same by various assay methods.

Ensured products manufactured and distributed met all quality and compliance requirements

Assisted in writing protocols and batch records

Experience with GC, HPLC, FTIR, Rheology, Surface Tension testing, DSC, Particle Size Analysis

Performed light maintenance whenever required

EDUCATION:

Fairleigh Dickinson University, Teaneck, NJ M.S. Degree 2014

Received Masters of Science in Chemistry

GITAM UNIVERSITY, Andhra Pradesh, India B.S.Degree 2012

Received Bachelor of Pharmacy

Skills :

HPLC, GC, LC-MS, TEM, SEM, Fluorescent microscope, GUAVA flow cytometer, Ion Torrent Next Generation sequencers, PCR, qPCR, DNA amplification, DNA purification, Thermo cycler, enzymatic assays, Plate reader, UV spectrophotometer, Tangential flow filtration

UNDERGRADUATE PROJECT:

Worked on enhancing the bioavailability of an insoluble drug Piroxicam using cyclodextrins

Cross linkers as part of a group. Used various techniques of encapsulation to make

Piroxicam-cyclodextrins nanoparticles and tested them for improved bio-availability by

Various assay techniques. Performed kinetic studies and accelerated stability studies as well.

ACCOMPLISHMENTS:

Awarded 3rd prize for a poster presentation, presented at a conference held by New York Society for Cosmetic Chemists on the topic Lanthibiotics for Enhancing the Shelf life of Nano chitosan

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