Data Time

Objective

A go-getter with * years of professional experience in process analytics and method development of biopharmaceuticals (Therapeutic proteins). Pro-active, detail oriented with problem solving skills. Looking for an opportunity to apply the acquired competency and experience to contribute for organizational goals and vision.

Professional Experience

Research Associate - Analytical Development and Variant Characterization

Biologics Development Center, Dr.Reddys Laboratories, Hyderabad.

June 2017 – March 2020

Academic Background

M.Sc. Biotechnology, (2015 - 2017)

Bharathiar University, Coimbatore.

Percentage: 72.7%

B.Sc. Biotechnology, (2012 - 2015)

K.S.G College of Arts & Science, Coimbatore.

Percentage: 77%

Higher Secondary Education, (2010 - 2012)

Kadri Mills Higher Secondary School, Coimbatore.

Percentage: 78%

SSLC, (2009 - 2010)

Kadri Mills Higher Secondary School, Coimbatore.

Percentage: 89.6%

Technical Experience

Analytical Development

Method development:

Developed size exclusion chromatography method to quantitate the ‘impurities and aggregates’ for IgG4 monoclonal antibody.

Developed SDS-PAGE separation method for ‘identity and purity analysis’ of IgG4 monoclonal antibody.

Method validation:

Validated strong anion exchange chromatography method as an inter analyst for a light sensitive fusion protein.

Stability:

Analysed the real time and accelerated stability samples for impurities, charge variants to provide the supporting data for the analytical biosimilarity package of IgG1 monoclonal antibody.

Stress study: Performed the ‘thermal stress study’ for IgG1 to compare the commercial cell culture process and the lab scale process to understand the variability in the impurities and charge variants at drug product stage.

Process Analytics

Clone Selection: Worked in the Top clone selection for a light sensitive fusion protein and IgG2 monoclonal antibody by providing the titre and charge variants quality data.

Scale up Activities: Worked in the different scale up campaigns of IgG1 molecules (upto 1kL) to provide inline analytical quality data on time.

Hold time and Freeze thaw study: Worked for the multiple hold time and freeze thaw studies to provide the real-time analytical data to support viral validation.

Buffer screening study: Worked for the buffer screening for IgG1 molecule by analysing the high concentration samples for analytical quality data.

Other activities: Worked for filter sizing studies, CCCB hold time studies, DBC study, and other product and process life cycle activities, regulatory dossiers handling for the CTA filings and FDA queries.

Others

Experienced in Fermentation process development and standardization for Microbial probiotic strains (Lactobacillus strains) in large-scale up to 1kL and 2kL.

Experienced in Sequential blending of the microbial products (Like probiotic feeds, Bio fertilizers)

Hands-on-experience in analysis of pH, Osmolality, Viscosity, Conductivity for drug product and intermediates.

Hands-on-experience in Cell culture processes, Protein purification, Biochemical assays.

Hands-on-experience in Capillary electrophoresis and HOS methods - Circular dichroism spectrometry, Differential Scanning Calorimetry, Differential scanning fulorimetry.

Performed periodical calibration of HPLC and UPLC systems, and IQ, OQ, PQ for the new instruments installation.

Achievements

Provided continuous support to the process development teams by analysing the samples in real-time during scale up activities, top clone selection and new process development.

Provided 180 days of real-time analytical data of impurities and charge variants for the process intermediate to support the viral validation.

Declaration

I hereby declare that all the information provided above truthful to my knowledge

Yours Sincerely,

Vivek.M

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