Narasimha Gowtham

Plot No.: 76, Pragathi Nagar, Kukatpally, Hyderabad, PIN: 500090

Mobile: +91 9908698530, email: d.s.n.goutham@gmail.com

Professional Summary
Experienced biochemical engineer (7 years) with a demonstrated history of working in the bio-similar industry. Strong
research professional skilled in mammalian cell culture, biosimilar production, perfusion technology, manufacturing scale
up and process life cycle management.

Work Experience
Senior Scientist (TEAM LEAD), March 2014 – Present (5 years)
Research and Development – Biologics Division, Dr. Reddy’s Laboratories LTD., Hyderabad, India.
Cell Culture Process Development (mAb Production) -Fed batch
 Clone, media and feed screening to identify top clones and top media/feed using shake flasks and AMBR-15 (24
and 48 culture systems).
 Selection and optimisation of process parameters to increase bioprocess productivity whilst achieving target
product quality profile.
 Design and conduct experiments using DoE approach.
 Perform data analysis using statistical tools to help identify critical process parameters.
 Scale down model development of cell culture processes and its statistical qualification.
 Preparation and reviewal of technical reports and data summary documents for scientific publications, regulatory
submissions and patent applications.

Highlights

 Team Lead – Supervised a four-member team to deliver projects within aggressive schedules.
 Worked on multiple cell line platforms including CHO, NS0 and SP20.
 Skilful at handling AMBR-15 (24 & AMBR 48 Culture Stations), Vi-CELL XR, Nova BioProfile FLEX Analyzer, CEDEX
BioHT Analyser, Advanced Osmometer, Blood Gas Analyser, Guava easyCyte Flow Cytometer, Octet QKe System,
ATF C24 and C410 control systems.

Perfusion Platform – mAb production

 Perfusion based concentrated fed batch process development using Alternating Tangential Flow (ATF-2 and ATF-
4) Systems.
 Development of small scale perfusion models in shake flasks and AMBR-15 to increase throughput.
 Process optimization to reduce media consumption using metabolite marker, spent media analysis & CSPR
approach.
 Knowledge on the process scale up to 200L and 1000 L using ATF-10 Module.

Scale up/Technology Transfer & Process Life Cycle Management

 Process optimization, scale up and technology transfer to single use (1KL) and SS STR (1KL) systems.
 Conduct bioreactor characterization studies (kLa, OUR & mixing time etc.,) in small scale (5L and 10L) and in at-
scale (200 L and 1000 L) vessels.
 Preparation of DFQ and Evaluation of manufacturing facility to draft DFM and give necessary recommendations
to facilitate technology transfer.
 Preparation and reviewal of scale up proposals, technology transfer protocols and process description summaries
to facilitate process scale up.
 Review existing manufacturing processes to identify opportunities for yield improvement or reduced process
variation and provide support for FDA-IND, PAC and DCGI filings.

Junior Research Associate, January 2012 – March 2014 (2 Years)

Research and development – Biologics Division, Kemwell Biopharma PVT. LTD., Bangalore, India

Process development-Upstream

 Involved in laboratory activities such as medium & feed preparations, handling of shake flasks, bioreactors (3L,
10L, 80L), in process sample analysis.
 Involved in the optimization of process parameters to improve productivity whilst maintaining bio similarity.
Biopharma Plant Setup and Commissioning

 Involved in setting up a fully functional laboratory & a manufacturing facility as per the design.
 Involved in URS preparations and vendor evaluations to procure GMP equipment.
 Involved in document review and execution of FAT/SAT of the at scale bioreactors and other equipment’s.
 Involved in the IQ/OQ/PQ of various equipment such as bioreactors, analytical/metabolite analysers, kill tank
systems etc.

Awards and Honours

 Received STELLAR PERFORMER OF THE YEAR – 2016-17 award for contribution in the process development and
executing the consistency of a fed batch process at Dr. Reddy’s laboratories.
 Received two levels of promotion in the period of 4 years at Dr. Reddy’s laboratories.
 Received the BCIL fellowship for 2012 by the Department of Biotechnology – Govt. of India.

Academic Qualifications
VIT UNIVERSITY, Vellore, India
Master of Technology in Biotechnology, June 2009 - May 2011
 Cumulative GPA 8.47 on 10.00

JNTU Ananthapur, Ananthapur, India

Bachelor of Technology in Biotechnology June 2005 – May 2009
 Aggregate: 74 %

Academic Research Experience

 A Project on “Pretreatment of Corn cobs for production of Sugars”, at Indian Institute of Chemical Technology
(IICT) – Tarnaka, Hyderabad.
 A project on “Production of Cellulases from Isolated Fungal Strains using Stirred Tank reactor”, under the
supervision of Dr. Annapurna jetty (Scientist-F, BEEC) at Indian Institute of Chemical Technology(IICT) –
Tarnaka, Hyderabad.
 A Project on “Studies on bacterial Immunoglobulin like domain proteins and their biophysical characterization”
under the supervision of Dr. Yogendra Sarma, scientist at Centre for Cellular and Molecular Biology(CCMB) –
Hyderabad.
 Industrial training sponsored by Biotechnology Consortium of India Limited (BCIL) & DBT in Kemwell Biopharma
Pvt Ltd. Bengaluru on “Large Scale Manufacturing of Monoclonal Antibodies”.

Posters/Patents/Publications
 Co-authored in the article “The cost effective stirred tank reactor for cellulase production from alkaline pretreated
agriculture waste biomass” published in Utilization and management of bio resources [proceedings of 6th
ICONSWM 2016].
 Poster titled “Strategies to modulate charge variants of a Biosimilar monoclonal antibody through cell culture
conditions” presented in Cell Culture engineering conference XVI 2018.
 Filed a PCT patent application on “cell culture process comprising modulating the concentration of amino acids in
a cell culture media to control the acidic variants or galactosylated glycans in an antibody composition”
[ WO 2017/122157 Al].

References
Dr. Prafulla Mahajan, Jagadeesh K
Principal Scientist - I, Principal scientist,
Dr. Reddy’s Laboratories Ltd., Hyderabad Kemwell Biopharma Pvt Ltd, Bangalore
prafullamm@drreddys.com k.jagath@gmail.com
Contact No: +91- 7032969519 Contact No: +91- 9686602408

I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief

Narasimha Gowtham
Hyderabad, 18-Febrauary 2019