Praveen Kumar Galla has over 10 years of experience in the biopharmaceutical industry, having worked at companies like Biocon, Wockhardt, and Syngene. He currently works as an R&D Manager at GeneSys Biologics, leading a team that is setting up a laboratory for microbial expression. Praveen has expertise in upstream and downstream processing, process development, equipment operation, and cGMP compliance. He aims to take on new challenges and help the Indian biopharma industry through roles in middle management.

1. Profile Summary
Praveen Kumar Galla praveengalla7@gmail.com
10 Year’s Experience +91-8884189456
+91-8055632008
I introduce myself as a young dynamic professional, graduate,
completed my M.Sc., Biotechnology course. I do enjoy challenges and work smartly to
attain my goals. I am Mr. Praveen Kumar. Galla working as a Manager leading the process
development team in a science based Bio-Pharmaceutical Company GENESYS BIOLOGICS
PRIVATE LIMITED, HYDERABAD in the field of recombinant biotherapeutics. I have a decade
of rich working experience in Up-stream processing, Down-stream processing, Process
development and Quality management in processing of recombinant DNA Therapeutic
products in Biotech firm. I have strong belief in ethics, values and transparency which have
been the driving factor throughout my career.
I have the capability of shouldering responsibility and privilege of working
with people from various walks of life with different temperaments. I am looking for fresh
challenges. Serving the Indian Biopharmaceutical industry for a decade in middle
management roles. Worked with the Indian Biotech majors BIOCON LTD, WOCKHARDT
BIOTECH LTD, SYNGENE INTERNATIONAL LIMITED (A subsidiary of Biocon).
Expertise in handling and troubleshooting of fermenters, Bioreactors, Filtration systems and
chromatography systems at various stages from cell banks to final API at developmental,
pilot and manufacturing scales.
Worked on varied products and Biosimilar ranging from Statins to Monoclonal Antibodies.
Delivered high sterility rates and improved productivity in Erythropoietin, Insulin analogs
and Statins Mfg.
Areas of expertise:
♣ Product development * Upstream Processing
♣ Downstream processing * Facility commissioning
♣ Equipment qualification * Process validation
♣ Audit and compliance preparations * cGMP documentation
♣ Product planning and people management * Team Building
♣ Scale up and Technology transfer * Able to manage Multiple task
♣ Handling of multiple projects and products
♣ Data analysis and trouble shooting
♣ Change control, discrepancies and CAPA management
♣ Inventory management of spares consumables and raw materials

2. CAPEX budget preparation and procurement. Development/review of URS, FS and P&IDs.
• Retrofit/Renovation of Biopharmaceutical manufacturing facility, utilities and equipment.
• Drive conceptual design/Eng, procurement, installation, commissioning and qualification.
• Developed scale up methodology and created a scale up approach document.
• Successfully scaled up cell culture and microbial upstream processes.
• Project manager for cell culture based mAb product to US client. Coordination with client,
QA, QC, Process Development, supply chain, BD, Engineering and vendors on manufacturing
related issues.
• Investigation of process deviations & CAPAs related to process infrastructure.
• Performed Operational Risk Assessment and quality risk assessment for the Biologics
manufacturing on Cell culture suite and Microbial suite through application of FMEA
principles to minimize the operational and quality risk in Biologics manufacturing facility.
Worked out on strategies for cost effective manufacturing of quality products
Work History
⇒ Working as an R&D Manager involved in setting up of the Laboratory for microbial
expression platform @ GeneSys Biologics Private Limited, Hyderabad.
⇒ Worked as an Assistant Manager leading the upstream group for the manufacturing of
microbial and mammalian cell lines on various projects from global clients from
October 2014 to July 2015 @ Syngene International Limited, Bengaluru.
⇒ Worked as a Senior Executive leading the manufacturing group for Recombinant
Therapeutic Protein (Erythropoietin) at Wockhardt Biotech Park, Aurangabad from
August, 2008 to till date.
⇒ Worked in Quality Assurance for Quality management system, Batch release, BMR,
BPR & BDR Reviews and other documentation for two years from Apr 2010 - Feb
2012.
⇒ Worked as a Junior Executive in the production of Statins at Biocon Ltd. Bangalore
from July 2006 to August 2008.
Products Handled
(i) Monoclonal antibodies
(ii) Interferon
(iii) Recombinant proteins(E.coli)
(iv) Erythropoietin – Chinese Hamster Ovary Cells
(v) Insulin Human – Hansenula polymorpha
(vi) Insulin Glargine – E.coli
(vii) Lovastatin technical – Aspergillus
a. pravastatin sodium technical-Aspergillus
b. Lipstatin - Aspergillus
EQUIPMENTS HANDLED
• Bio-Engineering bioreactors ranging from 5Lt, 50Lts, 200Lts.
• Akta prime plus, Schimadzu HPLC, Analytical HPLC and Lyophilizer systems.
• Water purification system, Vertical Autoclave, Homogenizer and Centrifuge.
• Handling of Tissue Culture Flasks, 500 ml Spinner & 1 Lt Spinner Flasks.
• Alfa Laval Fermenters and IDMC Fermenters in the range of 15lts, 20lts, 100 lts,

3. 150lts, 200lts, 1 kl,1.5 kl, 2 kl, 10 kl, 15 kl, 20 kl, 120 kl.
• Worked on DCS (Distributed control system), PLC operating systems.
• Nutrient dosing vessels in the range of 5 kl, 10 kl.
• Shakers, CO2Incubators, Bacteriological Incubators, Air handling Units, cold
rooms.
• Inverted Microscope, Laminar air flow units, Osmometer, Lyophilized container.
• Dry heat sterilizer, moist heat sterilizer and Tangential Flow Filtration System.
Other Activities/Achievements
 Internal audit team member and safety committee member.
 Involved in preparation of MCB and WCB for Darbepoietin, Trastuzumab &
Rituximab.
 Improved the Erythropoietin productivity per batch from 3 g to 5 gm by
optimising the process parameters and improved productivity of lovastatin
from 15 g/L to 22 g/L.
 Reduced the contamination rate in Mammalian cell culture by designing systems
and operational procedures.
cGMP Documentation/Compliance:
• Preparation and Review of BATCH MANUFACTURING RECORD, SOP`s, Process
Validations and other related documents.
• Initiating /Raising change controls to keep the system current.
• Appropriately handling the deviations if any and maintaining the records.
• Giving training on various process techniques and procedures including cGMP aspects.
• Initiating investigations & CAPA in case of batch failures.
Educational Qualification
 Master of Science in Biotechnology, Barkatullah University.
 Bachelor of Science in Microbiology, Sri Venkateshwara University.
 IELTS Cleared with 6.5/9.0 from British Council.
Strengths/Abilities
1 Hard working with Positive attitude, pro-active and detail oriented.
2 Ability and Confidence with Applicability and ability to meet targets.
3 Disciplined, motivated, team building and fast learner.
Personal Details:
Name : Praveen Kumar G
Date of Birth : 07 August 1982
Father Name : Sri. G. Ramachandra Naidu
Mother Name : Smt. G. Vijayalakshmi
Passport No. : F2741556
Marital Status : Married

4. Address : GallaVallaVuru,
Thavanampalli(P&M),
Chittoor, (Dist)
Andhra Pradesh.517131.
08573-283292