Dr. Durga Reddy.G.A.N.K.
Raichur
Summary
High-energy, results-oriented and problem-solver R&D Manager/Project leader with extensive experience in product development , project management, regulatory submission, outsourcing, compliance, and quality assurance. Decisive leader with a proven track record in fast-paced, highly competitive environment and knowledge, a passion for innovation and teamwork that delivers successful solutions to complex projects and drives growth, productivity and reduce cost. Experienced and knowledge of drug discovery, drug development, and commercial manufacturing processes. Experience in:
- 14years of work experience from Synthesis of KSM, Drug substance and Drug intermediate.
- Searching the journal and patent to create the Non-infringing route with IP edge.
- Design the route of NCE molecule-Medicinal Chemistry
- Process development and cost reduction
- DMF filling, customer compliance and CAPA
Overview
14
14
years of professional experience
Work History
Manager
SHILPA PHARMA LIFESCIENCES LTD
Raichur
09.2013 - Current
- Lead the team of Scientists to develop the process technology and related process impurities/pharmacopoeia impurities for new DMF filling for regulated markets.
- Responsible to ensure environment friendly, plant feasible and robust process.
- Synthesis the required impurities to address the DMF deficiency query.
- To identify the process criticalities in the scale-up trail observation addressed and proceeded further for the execution of plant validation as per timeline.
- To collaborate with cross factional team like manufacturing, QA, RA, IPM, Business development, Finance etc.,
- To ensure the team follows the lab safe working procedure while working in the lab.
Sr.Chemist
SAPALA ORGANICS PVT LTD
Hyderabad
09.2011 - 09.2013
- NCE-(Medicinal Chemistry) (Synchronized with Meiji Seika Pharma, Japan)
- Responsible for the coordination and completion of specific project task within tight deadline.
- Separation/isolation of molecule and Structural identification with NMR, Mass and etc.,
- Carried out day-to-day duties accurately and efficiently.
Research Scientist
BIOCON LTD
Bangalore
01.2009 - 08.2011
- Hands-on process R&d and scale-up of organic synthesis reaction and isoaltion.
- Research and development novel cost-effective process using standard approaches
- Develop the SM, Intermediate and API with safe, efficient and easily scalable process.
- Molecule, optimized (Scale-up studies) condition to get qualitative yield and technology transfer to the plant.
Education
Ph.D. - Organic Chemistry
Karpagam University
Tamilnadu, India08.2015
Master of Philosophy - Organic Chemistry
Dr. M.G.R.University
Tamilnadu, India12.2007
Master of Science - Chemistry
Bharathidasan University
Tamilnadu, India06.2006
Skills
- Successful in handling multi-step synthesis projects
- Successful in handling projects of custom synthesis in Pharmaceutical services where deadline matters
- Familiar with the common lab techniques such as handling dry reactions, purification techniques that occurred during synthesis
- Optimize the process by considering yield, quality, cost, safety and solvent recoveries, and reusability of existing and new molecules
- Lead and guide the team of scientists for the development and optimization of economical and commercially viable synthetic processes and transfer the same in the plant
- Coordinate with various departments to deliver the products and complete successful DMF filing
- Compliance of ICH guidelines for impurities/Residual solvents/Metallic impurities
- To ensure projects completion up to plant validation in time to create marketing opportunities for the products
- Experience over collecting Literature Using Manual Resources Viz CA, Journals & Handbooks as Electronics Resources Viz, REAXYS and SCIFINDER
- Create IP edge thru novel intermediate/polymorph and file the process patents
- To accomplish the trouble-free plant demonstration and resolves to scale up the problem during commercial batches
- Prepare of DHR of all the validated products and specification
- Experience in conducting high-pressure reactions (autoclave), Lyphilizer, flash column with pump (biotage) etc
- Chromatographic Techniques: Columns (Gravity and flash), TLC, HPLC and GC
- Distillation Techniques: Simple Distillation, Fractional Distillation, Steam Distillation Freeze Drying
- Spectroscopic Techniques: Structural Elucidation of Organic Compounds using UV, NMR, IR, Mass Spectrometry and more physical study of XRPD, DSC and TGA
- Document Skills Set: MS Office Documents preparation as per laboratory Require like Drug history report (DHR), Technology Transfer Document (TTD) etc
- Safety awareness: Experience in the handling different hazardous chemicals with proper safety measures and good lab practices Knowledge of searching MSDS and its proper utilities
Affiliations
Catalytic synthesis of a few novel Nitrogen and Sulfur Heterocycles.
Accomplishments
Patents and Journals :
- Process for Temozolomide, Indian Patent Application No.201941048536
- Process for Cladribine, Indian Patent Application No. 202141005294
- Crystalline Bortezomib Process, Indian Patent Application No.202141029938
- A Cu (NO3)2.3H2O catalyzed facile synthesis of substituted 4(3H)-quinazolinones and Benzimidazoles., J. Chem. Sci. Vol. 125, No. 1, January 2013, pp. 175–182.
- A CaO catalyzed facile one pot synthesis of 2-aminothiophenes using Gewald reaction., Der Pharma Chemica, Vol 5, Issue 6, 2013, PP.294-298.
List of Handled KSM/Intermediate/API molecule:
- Abiraterone acetate (USP)
- Capecitabine (USP/EP)
- Bortezomib
- Cladribine (USP/EP)
- Cabazitaxel
- Dimethyl Fumarate
- Temozolomide (USP/EP)
- Zoledronic acid (USP)
- Busulfan
- Irinotecan Hydrochloride
- 1,2,3-Triacetoxy-5-Deoxy-β-D-ribofuranose
- 5-Amno-4-imidazolecarboxamide
DMF Filled Projects:
- Capecitabine (USP/EP)
- Fingolimod hydrochloride
- Dimethylfumarate
- Busulfan
- Zoledronic acid (USP/EP)
- Bortezomib
Personal Details
Name : Dr. Durga Reddy. G .A .N .K.
Father name : Ramachandra Reddy. G.
Date of Birth : 15th May 1983.
Marital status : Married
Nationality : Indian
Interest of fields : Laboratory Chemistry
Present Address : Dr. Durga Reddy. G.A.N.K. S/o G.Ramachandra Reddy Yeguva Cherlopalli (post) Pedda dornal (mandal) Prakasam (dist)
PIN-523331
Andhra Pradesh, India.
Hobbies : Reading books and Playing Cricket
Languages Known : English, Telugu, Tamil, Kanada and Hindi
Timeline
Manager
SHILPA PHARMA LIFESCIENCES LTD
09.2013 - Current
Sr.Chemist
SAPALA ORGANICS PVT LTD
09.2011 - 09.2013
Research Scientist
BIOCON LTD
01.2009 - 08.2011
Ph.D. - Organic Chemistry
Karpagam University
Master of Philosophy - Organic Chemistry
Dr. M.G.R.University
Master of Science - Chemistry
Bharathidasan University
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