acvede@r.postjobfree.com

+1-404-***-****

Georgia, USA

Professional Profile

• Biochemical Engineer with 5 years of experience in Pharmaceutical and Biomedical-device Industry.

• Method Validation – Stability Studies – Analytical instrument calibration/ qualifications – Downstream Processing – SOP writing - Training.

• Experience in managing activities across different sites and contract laboratories.

• Educational qualifications that add management skills on to technical expertise and regulatory knowledge relevant to the industry. Industry Experience

Analytical Method Validation Consultant

Johnson & Johnson (Through Kelly Services), Cornelia GA December 2014- June 2016

• Led activities for Test Method Remediation and Validation Project for the remediation of all test methods used across the site.

• Co-ordinated and reviewed the validation activities at Contract sites and managed the transfer activities on-site.

• Prepared and reviewed protocols and reports for the in-house validations including chemical test method validations and Gage R&R studies for physical test methods.

• Evaluated analytical methods used for the raw material testing, in-process and routine release testing of products for gaps, adequacy and compliance to cGMP and proposed improvement plans.

• Trained production and lab associates on new and improved test methods.

• Prepared and updated SOPs and managed changed controls for the associated changes.

EDUCATION:

Professional Science Masters’

Bio-manufacturing and Bio-

processing

University of Georgia, Athens GA

2014

Bachelors’ Degree

Biotechnology and Bio-Chemical

Engineering

University of Kerala, India

2008

Certificate Degree

Pharmaceutical and Biomedical

Regulatory Affairs

University of Georgia, Athens GA

2014

Lab skills

HPLC (Agilent / Waters)

GC (Agilent/ Schimadzu)

AKTA Purification systems

Bio-assay, ELISA

DNA isolation and Q-PCR

SDS-PAGE, IEF

Western Blotting

Particle size analysis

IR/ UV/SOR/ KF Titration/ TOC

Kjeldahl nitrogen estimation

Bio-Process Development Intern

Sanofi (Merial Limited), Athens GA

February 2014 – December 2014

• Successfully completed the scale up and validation of downstream process for animal DNA vaccine.

• Handled Ion-Exchange chromatography and size exclusion chromatographic techniques using AKTA systems, continuous centrifugation, alkaline lysis of bacterial cells, filtration on pilot scale for purification of different protein and DNA vaccines, concentration and purification of viral vaccines using tangential flow filtration system. Quality Control Chemist

Biocon Limited, Bengaluru, India.

August 2008 - April 2011

• Handled quality analysis of active pharmaceutical ingredient (both small molecules and biologicals) for routine release.

• Planned schedules and conducted stability analysis of drug substances: Job included preparation of protocol for stability analysis, carrying out analyses in accordance with USP, Ph.Eur or in-house specifications, summarizing the Georgina Elizabeth George

Soft skills

Instrument softwares

Chemstation/ Chemstore

Empower 2

PLA 2.0

Stratagene MxPro Software

Statistical softwares

Minitab

JMP

STATA

Document management systems

Adaptiv

Lotus Notes

Languages known

English

(Read - Write – Speak)

Malayalam

(Read - Write – Speak)

Hindi

(Read - Write – Speak)

results of stability studies for trending. Handled packaging material study for evaluating the stability of an API.

• Validation of analytical methods: Validation of HPLC method for in-process analysis of drug substance; GC method for determination of residual solvents content in drug substances.

• Validation of excel sheets used for calculation of assay, Impurity content and residual solvents of routine release batches across the different company sites.

• Handled standardization of working standards and GC standards

• Conducted calibration of instruments: HPLC, GC, UV Spectrophotometer, IR Spectrometer, Karl Fisher titrator, TOC Analyzer etc.

• Prepared SOPs for instrument operations and analytical methods and provided responses to regulatory and customer based queries

• Trained new joinees as well as project interns on operation and maintenance of different instruments.

Additional Lab Experience

Research Assistant

Biochemical Engineering Lab, Driftmier College of Engineering, UGA August 2013- December 2013

• Worked on expression and production of organic acids in recombinant E.coli strains: Conducted plasmid isolation, transformation of E.coli cells by electroporation and screening, lab scale fermentation and analysis for product formation by enzyme activity.

Research Assistant

Bio-expression and Fermentation Facility, Athens, Georgia May 2013 – December 2013

• Successfully completed shifting, re-installation and calibration of Agilent 1100 HPLC from one lab to another.

• Experienced in setting up of fermenters, JMP software for Design of Experiments (DOE), downstream processing for purification of proteins including ammonium sulfate precipitation, Affinity Chromatography, Hydrophobic Interactions Chromatography, Hydroxyapatite column chromatography.

Summer Intern

Rajiv Gandhi Centre for Biotechnology, Trivandrum, India June 2007 - July 2007

• Assisted in meta-genomic study of soil microorganisms: Acquired hands on experience on metagenomic DNA library construction; screening of transformant; genomic and plasmid DNA isolation; restriction digestion; ligation, transformation.

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