Design Expert Software for DoE
Govind Ausekar
Assistant Director At Lupin R&D Centre
Pune
Summary
A strategic and result-oriented leader with over 22 + years with deep expertise in crystallization, polymorphism, flow chemistry, and process & particle engineering. Proven ability to lead multidisciplinary teams in developing, optimizing, and scaling robust chemical processes from research through commercialization. Recognized for translating complex solid-state and reaction engineering challenges into scalable, high-quality, and compliant manufacturing solutions while driving innovation and operational excellence.
Overview
22
22
years of professional experience
Work History
Assistant Director
Lupin Research Park
08.2010 - Current
- Led end-to-end Process Development and optimization initiatives to deliver efficient, cost-effective, and safe manufacturing processes.
- Specifically focus on crystallization process development for desired physicochemical properties as per formulation or customer requirements for meeting desired CQA such as PSD, metastable polymorph, BD/TD, Flow property, Morphology, Surface area etc.
- Process robustness study through DOE to derive the design space to operate at plant scale and defining the boundaries wrt to PAR/NOR.
- Usage of various PAT tools during process optimization to know how of the process and understand the science in depth.
- Had established best in class Process Engineering Lab at research centre with fully automation to establish the precision during process development and derive best operating parameters and CPP of the developed process.
- Hands on experience of handling parallel synthesis stations from Radleys, Mettler toledo and it’s extensive usage during screening DOE.
- Right solvent selection methodology adapted using automation platform like Crystal 16 & crystalline.
- Polarized Microscope intervention as fast track tool to match the desired morphology & identifying the amorphous and crystalline polymorphs exhibited in the products.
- In depth understanding of all analytical techniques used for solid state characterization of API which includes XRPD, DSC, TGA, DVS, SEM, BET, Malvern M4, Sympatech/Malvern instruments for PSD measurements, APSD data interpretation for inhalation DP etc.
- Hands on experience on usage of PAT tools like react IR, FBRM, PVM, Crystal Eye, Flow cell etc.
- All types of Filtration equipments explored during process robustness study like Centrifuge, PNF, ANFD, TFF, nano filtration etc.
- Established process intensification platform comprising Flow cell for continuous sonication, various Flow reactors like PFR with and without pinches/baffles, Slurry reactor (active mixing), Plate type flow reactor etc.
- Had developed crystallization processes for various therapeutic category products like anti TB, inhalation, cortico steroid, onco, anti inflammatory, antibiotic cephalosporin class, anti viral drugs, anti fungal, antihypertension, anti diabetic, cardiovascular, CNS, GI, respiratory, hormonal and endocrine, cortico steroid.
- Alignement with CFT involving RA, IP, GSCM, QA/QC, manufacturing, PM, validation, marketing, Formulation team to take forward the developed process from validation to DMF filing, query response etc.
Sr.Research Scientist
Ranbaxy Laboratories
06.2008 - 08.2010
- Technology development & Transfer of molecules developed at R&D and scale up data generation at kilo
- Equipment mapping ,HAZOP study,batch planning as per delivery schedule.
- Involved in the detailed procedures required for docs required prior to TT like process package part C,TT dossier etc
- End to end Tech Transfer of molecules to CMU as per business requirments.
- Co ordination with Cross functional teams to take forward the assigned project as per timeline set.
Executive (Tech Transfer)
Teva API India Ltd
02.2006 - 06.2008
- Tech transfer of overseas molecules at TEVA India
- R&D Study process packages received from R&D Israel,Hungery and necessary planning as per management strategy.
- Complete End to end planning from process evaluation, equipment mapping, co ordination with CFT for validation batches.
- Meet target Delivery of the API as per predefined specifications
- Exposure to FDA audits twice in the span of 2 years which led to successful outcome.
Officer
Ipca Laboratories
10.2003 - 02.2006
- Handled Role of shift in charge in production planning.
- Co ordination with respective procurement team,QC,QA to meet the production planning.
- Trouble shooting during production and ensure the targets are met as per production plan.
- Technical training to staff for equipments handling more effectively & avoid OOS ,deviation etc
Education
Master of Business Administration - Leadership and strategy, Operations and supply chain management
SVKM’s Narsee Monjee Institute of Management Studies (NMIMS)
Mumbai04.2023
BE - Chemical
MGM’s Jawaharlal Nehru Engineering College
Aurangabad, Maharashtra06.2002
Skills
- Crystallization Process Development
- Quality by Design (QbD)
- Cross Functional team knowledge
- Leadership & people management
- Project & Portfolio Management
- Regulatory,Quality & Compliance
- Communication and interpersonal skills
- EHS & Process Safety
- Digital Gadgets awareness
- Critical thinking
- Collaborative teamwork skills
- Strategic decision-making
- Prioritization and scheduling
- Data-driven decision making
- Conflict resolution expertise
Affiliations
Lupin Limited :
- Recipient of First to File (FTF) Product awards twice .
- Recipient of 6 times Value ranges awards for vital contribution in Product delivery/Development.
- Recipient of 4 times Bravo awards for best contribution in the Projects .
- More than 5 granted process patents in US out of which 2 were of first to file category product.
Ranbaxy Ltd :
- Runner up in Appreciate -2009 award for vital contribution in cost reduction & tech transfer of one of the key molecule of RLL.
- Receipt of Scientist of Month award for Process innovation & adapting purification through crystallization process by replacing costly and cumbersome Column chromatography .
Software
Dynochem
MixIT
Minitab & JMP
Timeline
Assistant Director
Lupin Research Park
08.2010 - Current
Sr.Research Scientist
Ranbaxy Laboratories
06.2008 - 08.2010
Executive (Tech Transfer)
Teva API India Ltd
02.2006 - 06.2008
Officer
Ipca Laboratories
10.2003 - 02.2006
Master of Business Administration - Leadership and strategy, Operations and supply chain management
SVKM’s Narsee Monjee Institute of Management Studies (NMIMS)
BE - Chemical
MGM’s Jawaharlal Nehru Engineering College