Vi-cell XR ver301
Nagaraja HM
Sr. Scientist I
Flat No-202, 2nd Floor, House No-1-24-654 Maruthi Nagar, Lothukunta, Secunderabad, India,TG
Intelligence is the ability to adapt to change.
Stephen Hawking
Summary
Experienced Cell biologist with over 10 years of experience in the field of Research & development and quality control in cell based and cell free assays. Excellent reputation for resolving problems and improving customer satisfaction. An active, sincere, hardworking professional having strong scientific knowledge and working experience in mammalian cell culture handling, Cell based assays, ELISA, qRT-PCR. Expertise in analytical method development, optimization, validation. Extensively involved in the analytical method technology transfer and stability assessment of drug substance and drug products. Able to multitask effectively in handling high pressure and able to prepare, review data, project reports, draft and review SOP's and IQ, OQ & PQ documents of various instruments to ensure compliance to the quality management system. Always adhered to the GLP, GDP and also effectively contributed for the preparation of internal audits and external audits such as ISO 9001 and ISO 17025 and participated in national and international collaborative studies. Excellent people manager with a proven track record of managing a team. Seeking a position to utilize knowledge & skills to fulfill the objectives of Organization so that, it can excel to a greater heights and to have an excellent career with dedicated people.
Overview
11
11
years of professional experience
8
8
years of post-secondary education
1
1
Certificate
4
4
Languages
Work History
Sr.Scientist I
United States Pharmacopoeia
Hyderabad , Telangana
08.2021 - Current
- Participated in more than 10 national and around 3 international collaborative projects for evaluation and establishment of national and international standards for cell based assays.
- Continuous suitability for use- contributed in more than 5 CSU projects (stability study) to evaluate reference standards through enzyme activity assays and cell based assays.
- Development of performance standards - establishing new methods for proof-of concept (POC) projects for development and evaluation of performance standards for cell based assays and flow based methods.
- Method development, Qualification planning, data analysis strategy and report preparation for wide range of cell based assay platforms using DOE approach and as per USP suite of general chapters (GC's)
- Planning and execution of bridging studies (compatibility studies) of different cell based assay platforms to evaluate suitability of methods.
- USP qualified instructor for lab demonstration of cell based assay and Residual DNA quantification (qRT-PCR method) compendial methods.
- Initiated new assay platforms for establishment of proof-of-concept study of bacterial enumeration using Flow-cytometry.
- Evaluation of USP's blood factor (Factor VIIa, LMWH) reference standards using Coagulation analyzer (STACompact Max).
- Mentored other Scientists in team on technical aspects, new methodologies, QMS, GDP and GLP's.
- As project lead for all Collaborative, CSU, POC projects, guided and helped scientists to troubleshoot and complete tasks on time and peer reviewing documentation, data, reports and involving in project audit discussions with QA.
- Engaged in posters preparation and presentation during USP Science day event. Carried out day-to-day duties accurately and efficiently.
- Responsible for organizing lab during internal audits, facility audits and external stakeholder visits.
- Used critical thinking to break down problems, evaluate solutions and make decisions. Prepared variety of different written communications, reports and documents.
Scientist III
United States Pharmacopeia
Hyderabad , Telangana
10.2018 - 08.2021
- Planning and performing multi-well bioassay using suspension and adherent cell lines such as M-NFS60,A549,L929,HUVEC, Nb2-11, UMR106, Glucagon receptor cell line for proliferative assay, anti-proliferative assay, neutralization assay, cytokine assay and cyto-toxicity assay.
- Planning and execution of multi well Bioassay's as per compendial procedure(Monographs) for CSU and Collaborative projects and data interpretation using PLA and Graph pad prism software's. And to aid in modernization of USP monographs as well as general chapters. Hence primary mission is to involve in improving global health through public standards and related programs that help ensure quality, safety, and benefit of medicines and foods.
- Worked on virological methods- End point dilution assay, virus neutralization assay (CPE assay) and qRT-PCR for residual DNA analysis for evaluation of USP reference standards.
- Skilled at handling detection methods such as LUM, FLU, TR- FRET (HTRF), ALPHAScreen, cAMP-Screen & cAMP- screen direct readout technologies.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Sr.Executive
Kemwell Biopharma Pvt.Ltd
Bangalore, Karnataka
09.2016 - 10.2018
- Analytical method transfer, optimization and validation of different ELISA's such as KI ELISA and CpB Quantification ELISA.
- Performed Analytical method transfer, optimization of CDC assay using WIL2s cells.
- Validation protocol and report preparation for different ELISA's and Bioassays as per ICH and USP guidelines.
- Stability assessment of Drug substance and Drug product at different time points with aid of ELISA and Bioassay methods.
- Planning workflow and training team members on ELISA and bioassay methods.
- Reviewing IQ, OQ and PQ documents and summary report preparation.
Executive
Kemwell Biopharma Pvt.Ltd
Bangalore, Karnataka
01.2015 - 08.2016
- Prepared SOP's and STP's for new and transferred methods.
- Planning and execution of different ELISA's such as Binding ELISA and Identity ELISA.
- Performed Anti-proliferative assay using BT-474 cells for in-house DS material and stability assessment of same at different time intervals.
- Residual host cell DNA determination and Mycoplasma determination by qRT-PCR for in-process and Drug substance material.
Research Associate
Virchow Biotech Pvt.Ltd
Hyderabad , Telangana
02.2013 - 01.2015
- Handled suspension culture of recombinant CHO cells expressing therapeutic protein in shake flasks and in spinner flasks.
- Performed Plaque assay and TCID50 assay for EMC virus titer determination.
- Maintained EMC virus culture for CPE assay for recombinant interferon.
- Performed cAMP assay to determine efficacy of rPTH.
- Prepared Sterile media and seed culture for bioreactor and handled sartorius biostat bioreactor(3-10 liter capacity).
Education
MSc in Biotechnology - Biotechnology
06.2009 - 07.2011
BSc in Biotechnology - Biotechnology
06.2006 - 06.2009
Pre University - Science
04.2004 - 05.2006
High School -
03.2003 - 03.2004
Skills
Cell based assays
Accomplishments
- Received scholarship from Department of Biotechnology to pursue BCIL training at Virchow Biotech Pvt.Ltd under BITP scheme.
Software
Gen5 ver30 and Softmax pro GxP 544
Graphpad PRISM ver 30
PLA 306
Step one plus, 7500 and 7500 fast
STA Compact Max ver 109
BD CellQuest Pro ver 6 and BD FACS Comp
Design Expert
Certification
BCIL certification
Interests
Reading story books
Programming languages
Playing cricket
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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References
1. Srinivasa Kumar Miriyala
Head of Analytical sciences
Just-Evotec Biologics
Occitanie, France
Email ID-Sri.biochemist@gmail.com
2. Shridhar Bagal
Quality control team lead
Beckman Coulter life sciences
Bangalore-India
Email ID- shr2.bag1@gmail.com
Timeline
Sr.Scientist I - United States Pharmacopoeia
08.2021 - Current
Scientist III - United States Pharmacopeia
10.2018 - 08.2021
Sr.Executive - Kemwell Biopharma Pvt.Ltd
09.2016 - 10.2018
Executive - Kemwell Biopharma Pvt.Ltd
01.2015 - 08.2016
Research Associate - Virchow Biotech Pvt.Ltd
02.2013 - 01.2015
University Of Mysore - MSc in Biotechnology , Biotechnology
06.2009 - 07.2011
Sahyadri Science College, Kuvempu University - BSc in Biotechnology , Biotechnology
06.2006 - 06.2009
Board of Secondary Education - Pre University, Science
04.2004 - 05.2006
Board of Secondary Education - High School,
03.2003 - 03.2004
BCIL certification
2012-07
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