Assistant Manager - Formulation and Process Development
Bengaluru
Summary
Expertise in implementing novel manufacturing technologies such as Hot melt extrusion/twin screw granulation, Lipid based technologies and fluid bed processing techniques along with conventional granulation techniques.
Highly proficient and expertise in designing strategies and process development of Sustained release dosage forms, taste masked powder for oral suspensions, Multiple Unit Particulate systems (MUPs) for delayed release application, fixed dose combinations (FDC), Emulsions, Microemulsions, Nanoparticles (polymeric and lipid based), Solid dispersions along with various conventional dosage forms like immediate release tablets and capsules.
Designing experiments in Hot Melt Extrusion (HME) / twin screw granulation technique by using different types of excipients for its applications in pharmaceuticals and preparing case studies from the results.
Establish processing conditions by conducting placebo experiments in HME for novel excipients (collaborating with specialized excipient manufacturers) and selecting a suitable plasticizers / other additive.
Experienced to improve process efficiency from batch process to continuous manufacturing process (reducing number of unit operations) and is proven with majority of NSAIDs and anti-malarial molecules.
Experienced in technology transfer of the process from laboratory scale to plant scale for different type of products and establishing suitable control strategies.
Sound knowledge in preparing product development strategies, patent search reports, technical reports, and presentations for review on progress of projects.
Experience in implementing Process Analytical Technology (PAT) in continuous manufacturing to ensure real time quality of the product.
Experienced in implementing Process Analytical Technology (PAT) in continuous manufacturing to ensure real time quality of the product. r-100), Zeta Sizer (Nano ZS), Freeze dryer along with conventional instruments such as Granulating equipment’s, Rotary tablet press, Fluidized bed processor (GPCG 1.1).
Have good experience on interpretation of raw data from analytical instruments such as DSC, XRD, SEM,TEM,TGA (Solid state characterization, Surface morphology of powders).
Have wide knowledge and hands on experience in analytical and bioanalytical method development using UV spectrophotometer, HPLC and in designing bio relevant dissolution conditions.
Hands on experience in pre-clinical studies. Lead a team of scientists and guided post graduate students on M. Pharmacy dissertation work during PhD Programme.
Overview
17
17
years of professional experience
9
9
years of post-secondary education
Work History
Assistant Manager- Generic drug product development
Cdymax (India) Pharma Private Limited
12.2021 - Current
Leading a team of scientists from the product prototype development to technology transfer to the production unit of generic formulations for the regulated markets – Oncology products
Design and develop process considering containment using pharmaceutical isolators
Application of various pH modifier excipients to enhance the dissolution of pH dependent soluble actives
Development of spray dried amorphous formulations using cellulosic based excipients for its enteric applications
Applying QbD principles to meet QTPP and assessing the impact of CPP and CMA on CQAs
Preparation of risk assessment reports (Formulation, process, elemental impurities, residual solvent, nitrosamine) and development reports for ANDAs and NDAs
Assessment of biopharmaceutical (solubility, absorption etc.) risk towards the bioequivalence issues by utilizing in vitro tools such as dissolution in bio-relevant buffers and development of discriminatory dissolution methods
Ensuring regular SOP trainings and updating the latest technical developments by regular presentations to the scientists
Assistant Manager- Process development
STEERLife India Private Limited
04.2021 - 12.2021
Identifying suitable molecules for their unmet clinical needs and to improve existing formulations by using novel polymers/additives (promote the solubility/alter the dosage regimen/improving the taste of actives for pediatric PFOS applications)
Evaluating the potential of existing cellulosic excipients in converting and stabilizing the crystalline molecule to amorphous molecule by designing customized HME process
Assessment of formulation challenges in scale up and biopharmaceutics risk (BA/BE) using suitable in vitro tool (solubility and dissolution Vs permeability) and utilizing modeling and simulation tools
Coordinating with cross functional teams such as analytical, stability, regulatory, intellectual property services and manufacturing plant team to deliver the project in time
Senior Research Scientist - Process development
STEERLife India Private Limited
11.2016 - 03.2021
Propose preformulation and formulation development strategies based on the extensive literature search and effective execution of proposed plan by implementing QbD approach
Formulated taste masked PFOS using novel lipid-based excipients using Cephalosporin anti-biotic and Macrolide anti biotic as model drugs
Successfully formulated amorphous solid dispersions with majority of anti-viral active ingredients, anti-fungal active ingredients and anti-psychotics for solubility enhancement using novel synthetic and cellulosic based polymers
Established processing conditions and applications in pharmaceuticals for the novel cellulosic based excipients in HME
Recommending and coordinating for the design features/requirements of equipment to Engineering team for the customized process based on process requirements
Closely working with clients to understand project requirements, timeline and communicating the progress of projects ensuring effective execution
Experienced in assessing the process parameters from lab scale to commercial scale and handled trouble shooting in the process as well as composition
Working with major pharma giants, from conception to implementation in transforming the current batch process of granulation steps to single step continuous manufacturing
Implementing PAT tools to ensure product quality parameters such as granule size, size distribution in a continuous manufacturing process
Formulated sustained release tablets for highly water-soluble molecule having release profile up to 12 hours
Successfully implemented current batch process of granulation to continuous wet granulation by Twin screw Processor to improve process efficiency (Proven with several large volume NSAID molecules)
Effectively involved in demonstrating the HME/HMG process in SteerLife-China to formulation scientists and Professors from reputed universities in China
Product Optimization Scientist
GSK Consumer Private Limited
05.2016 - 11.2016
Develop robust products by developing robust manufacturing processes
Conceptualizing and executing experiments using DOE software to establish design space
Assess commercial batches process capability and process performance data using statistical indicators Cp, Cpk, Pp,Ppk
Senior Research Scientist - Process development
STEERLife India Private Limited
05.2013 - 05.2016
Formulation of oral solid dosage forms using twin screw process
Literature search of publications from various databases such as Elsevier, Scopus and PubMed to meet scope of the project
Preparing patent search reports, analyzing claims and preparing strategies for non-infringement formulations
Reporting all critical aspects, documenting developmental activities, preparing Gantt chart to execute and deliver required outcome in a scheduled time
Ensuring the inventory and instrument calibrations for effective execution of projects
Have experience in establishing lab set-up (Involving in procurement of equipment’s by identifying suitable vendor and ensuring IQ, OQ and PQ)
Senior Research Fellow- (PhD Research student)
Manipal College of Pharmaceutical Science, Manipal University
07.2009 - 12.2012
Formulation and in-vitro, in-vivo evaluation of polymeric nanoparticulate drug delivery systems using PLGA and PCL for effective treatment of cancer
Formulation and in-vitro, in-vivo evaluation of liposomal drug delivery systems using cholesterol and phospholipids for effective treatment of cancer (Paclitaxel and Doxorubicin- Active and Passive targeted drug delivery system by parenteral administration)
In vitro and in vivo evaluation of Solid lipid nanoparticles and self microemulsifying drug delivery systems and liposomes for bioavailability enhancement (anti-hypertensive molecule)
Design and development of chronotherapeutic drug delivery systems
Research Executive
Orchid Health Care
08.2007 - 06.2009
ANDA products- Taste masked powder for oral suspension and Cephalosporin antibiotic tablets using Fluid bed processing technique (Taste masking of active using Eudragit polymers by Top spray granulation in GPCG1.1)
Delayed release capsule formulation using Eudragit polymer by Wurster coating of pellets
To evaluate the patent status of formulations (USA & Europe) and exclusivity status to interpret and understand various claims made in the respective published patents
Education
Doctor of Philosophy - Bioavailability enhancement of Candesartan cilexetil and Eprosartan mesylate using microemulsion technology
Manipal College of Pharmaceutical Sciences
07.2009 - 12.2012
Mater of Pharmacy - undefined
Manipal College of Pharmaceutical Sciences
08.2005 - 08.2007
Bachelor of Pharmacy - undefined
St’ Peters Institute of Pharmaceutical Sciences
12.2000 - 12.2004
Accomplishments
Graduate Aptitude Test in Engineering (GATE) qualified with 93.03 Percentile in 2005 and received scholarship for post graduate studies.
Received travel grant from Manipal College of Pharmaceutical Sciences to attend Indian Pharmaceutical Congress held in Ahmedabad, Gujarat during Dec 2009.
Received travel grant from European Commission to attend Nanoformulations 2011, Singapore, May 2011.
Served as Scientific Services Committee member for 62, 63, 64 Indian Pharmaceutical Congress (IPC) which was held at Manipal, Bangalore, Chennai respectively.
Presented research work various National and International Pharmaceutical conferences.
Research publications
Evaluation of surfactant effect on self microemulsifying drug delivery system (SMEDDS) of Lercanidipine hydrochloride: Formulation and evaluation., Journal of Pharmaceutical Innovation, 10, 4, 374-387, 2015
Role of components in the formation of self-microemulsifying drug delivery systems., Indian J Pharm Sci, 77, 3, 249-257, 2015
Self-Microemulsifying drug delivery systems: An attractive strategy for enhanced therapeutic profile., International Scholarly Research Notices, 2014, 964051, 2014
Formulation, characterization and in vivo evaluation of self-nanoemulsifying drug delivery system for oral delivery of Valsartan., Current Nanoscience, 10, 6, 263-270, 2014
PLGA 50:50 nanoparticles of Paclitaxel: Development, in vitro anti-tumor activity in BT-549 cells and in vivo evaluation., Bull. Mater. Sci., 35, 319-326, 2012
Sonophoresis- mediated permeation and retention of peptide dendrimers across human epidermis., Skin Res Technol., 18, 101-107, 2012
Novel drug delivery systems: A microemulsion based approach., Pharma Times, 42, 4, 2010
Novel Paclitaxel nanoparticles: Development, in vitro anti-tumor activity in BT-549 cells and in vivo evaluation., J Control Release, 148, 1, e119-21, 2010
Applications of nanotechnology in health care: Perspectives and opportunities., Int J Green Nanotech: Biomed., 2, 2, B119-B133, 2010
Chapters contributed in Text books
Microemulsions, Nanotechnology in Health Care, Shyam Prakashan, Jaipur, India, pp. 181-192
Formulation of gliclazide encapsulated chitosan nanoparticles: In vitro and in vivo evaluation., NanoFormulation, Royal Society of Chemistry (RSC, UK.), conference proceedings of Nanoformulation 2011, Suntec, Singapore
Preparation methods for nanoproducts, Exploring Nanotechnology in Health Care, Manipal University press, India
Declaration
I hereby state that the above- mentioned information is true to the best of my knowledge and belief.
(G. Aravind Kumar)
01 January 2025
Timeline
Assistant Manager- Generic drug product development
Cdymax (India) Pharma Private Limited
12.2021 - Current
Assistant Manager- Process development
STEERLife India Private Limited
04.2021 - 12.2021
Senior Research Scientist - Process development
STEERLife India Private Limited
11.2016 - 03.2021
Product Optimization Scientist
GSK Consumer Private Limited
05.2016 - 11.2016
Senior Research Scientist - Process development
STEERLife India Private Limited
05.2013 - 05.2016
Senior Research Fellow- (PhD Research student)
Manipal College of Pharmaceutical Science, Manipal University
07.2009 - 12.2012
Doctor of Philosophy - Bioavailability enhancement of Candesartan cilexetil and Eprosartan mesylate using microemulsion technology
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