1. Dhaneshkumar G. Desai
Phone: 9702206843,7575019964 E-Mail:dhanesh22desai@gmail.com
Address: Flat No. A/26, 4th Floor, Ajay Co. Op. Hsg. Society, Shimpoli Road, Behind Suvarna
Hospital, Borivali (W), Mumbai 400092
Title
A recognized Technocrat & chemical processing expert, in the field of API & FINE CHEM Industries
with the experience of Leading a team having no. of plant personnel, skilled & semi- skilled.
Looking for a good position in API manufacturing with an organization of repute.
Summary
Over 26 years of rich experience (20 yrs. in API manufacturing along with in PROJECT Erection in
DISTILLATION COLUMNS, PROCESS Plants (BATCH & CONTINUEOUS) with esteemed organizations
.(Majorly with Lupin Limited, Tarapur that is 20 years an Indian MNC having global foot print).
Expertise in process improvement / modifications / debottlenecking to enhance productivity. Proven track
record in implementing new process, cost reduction measures, Process Automation, Safety measures,
troubleshooting in existing plants and ensuring compliance of various quality measures. Resourceful at
strategizing techniques for maximum utilization of equipments.
Excellent grip over in API production with cGMP norms,faced various FDA audits
like US/MHRA/WHO & knowledge of Distillation of various solvent/by-product used
in API manufacturing for cost reduction of API . Deft with erection, commissioning & startup
of new plant. An excellent communicator, self driven with good analyzing and problem solving skills. A
recognized technocrat and an all time member of troubleshooting & task force team in Lupin Ltd.
Core Competencies
Production Planning & cGMP/Trouble shooting of process/Plant scale up
Worked on API plant manufacturing Simvastatin USP/EP and Sertraline Hydrochloride USP/EP for
generic market. Production planning for 8.0 Mt/Month of Simvastatin with five stage process & 3.0
MT/month of Sertraline Hydrochloride with three stage process. Handling team of 42 skilled
officers/Executives & 48 workmen. Production planning as per market requirement.
2. Documentation related to CGMP for API. Taken active part as a GMP coordinator & successfully
completed audits of agency like USFDA, MHRA &WHO. Familiar with ICH guidelines “Technical
requirements for preparation of API/Pharmaceutical ingredients”.
Interaction with PE, PD & R&D for cost reduction, process improvement like yield and quality.
Conducting routine audits for safety & GMP, with respective team.
Streamlining & scale up of the new process, establishing consumption norms & operational
methods. Familiar with change control process.
Developing new process concepts/Scale up in coordination with Process Development / R & D &
Process engineering.
Implementing cost saving measures & modifications to achieve substantial reduction in terms of
man hrs, mfg. cost, raw material & energy consumption, byproduct/ solvent recovery, Automation
& Mechanisation etc.
Analyzing various processes / applications, and recommending process modifications, suitable
equipment selection / sizing / designing to enhance operational efficiency.
Foreseeing performance bottlenecks & taking corrective measures to avoid the same.
Worked for establishing Solvent Recovery technologies & automation of distillation column.
Adopting novel technologies & percolating down the line with proper training.
Outsourcing the processes for intermediates mfg. or for byproduct recovery.
Evaluation & participation of PROJECT PROPOSALS with various engineering team.
Automation/Trouble shooting
Chalking out project requirements for automation of plant as per cGMP norms. Preparation of
proposals in co-ordination with PE/Engg./Project team.
Preparation & verification of Layout, PFD, P & I D, and specifications required for process.
Commissioning of equipments, with Qualification documents (DQ,IQ,FQ,VQ)
Participating in trouble shooting review meetings with PE/PD team for plant process to get desired
output with quality.
Installation and Commissioning of new equipments/instruments.
Conducting erection, testing & troubleshooting of various equipments/instruments.
Commissioning new process in terms of operating norms, Critical parameters, troubleshooting.
Optimizing man & equipment utilization, and cost parameters.
3. INDUSTRIAL EXPOSURE
Sr.
No.
FIELD No. of
Years
Organization
1 Production manufacturing API/
Chemicals/Intermediates
25 Lupin Limited, GTBL, Pioneer Industrial
Corporation, Vison Intermediates
2 Project Commissioning/ Plant
scale up
3 Lupin Limited, GTBL.
3 Solvents plant commissioning &
operations (Distillation/Extraction
Columns, Evaporators)
5 Lupin Limited
Employment Profile
1) Worked with M/S Vison Intermediate Pvt. Ltd. G.I.D.C. VAPI period 19/1/91to 1/5/92.
As a shift Incharge made Dyes Intermediate H-Acid.
2) Worked with M/S. Unique Chemicals, IIIrd Phase G.I.D.C. VAPI Period six month.
As a plant Incharge Manufacturing Chloral Hydrate.
3) Worked with Lupin Limited, Tarapur, Boisar. for 13 years period 21/11/1992 to11/03/06.
As a ‘Production Executive’ making RIFAMPICIN IP/BP/USP from Bio-Chemical process.Worked
in downstream isolation plant of Rifamycin-B, M-Acid for Lovastatin plant, and Rifamycin-s
extraction along with API plant. Exposure of solvent recovery process of solvent stream of above
product. During the period I have got FDA approval in bulk drug.
4) Worked with GTBL, Vapi period 21/03/2006 to 09/06/2008.
As a ‘Production Manager’ making RIFAMPICIN IP/BP/USP from Bio-Chemical
process. Looking behind set up of project & process stabilisation of Lovastatin /simvastatin
ammonium salt plant i.e. change over from Rifampicin to Lova/Simva from Bio-chemical process.
5) Worked with Lupin Limited, Tarapur period 09/06/08 to 10/06/14 ( six years).
As a “Manager Production” making SIMVASTATIN USP/EP & SERTRALINE
HYDROCHLORIDE USP/EP for generic markets. Along with this looking after behind complex
solvent recovery system/Bye-product recovery of the same product.
6) Worked with Pioneer Industrial corporation, Tarapur. 15/06/14 to 30/04/15 (10 months)
As a “GM manufacturing” looking behind solvent recovery, API Intermediate & contract
Manufacturing of various product.
7) Presentlyworking with Sterling Bio-Tech Limited, Masar, Vadodara since 01/05/15
As a “DGM Production” looking after new API products like Lovastatin,Simvastatin, Daunorubicin
& other new products.
4. Summary of work profile.
Manager – Production API (Heading the plant with around 40 Nos. of skilled & 50 nos. of
semi skilled personnel).
Production planning as per market requirement. Tracking of process as per cGMP
norms.
To plan & distribute work to be done for the day.
To analyse the batch data on day to day basis.
To ensure strict compliance of
Scale up of new products, Solvent Recovery & various cost reduction Programs.
Debottlenecking for capacity improvement, Project execution.
Technical support & troubleshooting in existing established plants.
Preparation of various Project / Technical proposals with basic & detail Engg.
Implementing new technologies. Automation & Mechanization in current processes.
Grooming the people in terms of cGMP/Safety competency. Prepare plant for various audits like
USFDA, MHRA,WHO etc.
Closing of OOS/Deviation in co-ordination of QC/QA/PE/PDL with proper scientific rational.
Cost reduction by means of improvement in yield/Bye-product recovery/solvent recovery.
Technical detailing in outsource manufacturing for cost reduction.
Intermediate plant commissioning, start up & stabilization.
Solvent column installation, start up & stabilization for various solvents.
Job work for various industries for RM/Intermediate manufacturing.
Audit compliance for the job work.
Quality & yield improvement for job work for cost savings.
Major participation in substantial reduction in manufacturing cost of various API’s/
Chemicals/solvent & bye-product recovery.
IT Credentials
Conversant with SAP ERP Module & Microsoft office.
Process Preview
Handled Manufacturing Processes of following API products .
Rifampicin with down stream.(Fermentation based)
Sertraline Hydrochloride .
Lovastatin (Fermentation based)
Simvastatin, Levetiracetam,Azithromycin.
5. Distillation schemes with various control systems & Automation through PLC/DCS.
IPA- WATER-CYCLOHEXANE Azeotropic Distillation
ACETONE –CHLOROFORM-WATER Extractive Distillation.
ACETONE-METHELENE CHLORIDE ternary system.
IPA- CHLOROFORM water ternary system
IPA-MDC, ACETONE- WATER, METHANOL- WATER, METHANOL- MDC.
Toluene-IPA & Toluene-MDC, Toluene-MEK & Toluene-Cyclohexane.
Dehydration of Ethyl Acetate, MIBK, Ethanol etc.
Various solvents viz. Xylene, THF, TEA, DMF, Sulfolane. etc
Bye- product of API from various API.
Dimethyl Butryl chloride
D- Mandellic acid.
Tri ethyl amine
Tri butyl tin chloride
Academia
Qualification Institute/Board/ University Year Percentage
M. Sc. Chemistry Techno Global University,
Meghalaya.
2013 67.5%
B. Sc. Chemistry Mumbai University 1986 50.75%
H.Sc. MV & LU college, Mumbai.
Poona Boarad.
1983 54.17%
S.S.C. N.D. Bhuta High school, Mumbai
Poona Board.
1981 74%
Achievements:
Overall improvement in yield of API & consumption reduction of key RM in all
products. Price reduction of Simvastatin from Rs.24,000/- kg to Rs. 9500/- Kg &
for Sertraline Hydrochloride Rs. 9000/- Kg to Rs. 7500/- kg.
Leader of a team bag USFDA approval in 2006 for Rifampicin plant at Lupin Ltd.,
Tarapur.
Second leader of a team bag USFDA approval in 2009 for Simvastatin & Sertraline
Hydrochloride plant at Lupin Ltd., Tarapur.
Leader of a team bag MHRA approval in 2010 for Simvastatin & Sertraline
Hydrochloride plant at Lupin Ltd., Tarapur.
Logic development & Automation of all distillation/Extraction columns in Lupin.
Automation for critical parameters in process plants.
6. Proposed, Designed, Executed around 5 capacity enhancement projects.
Chalking out requirement for new projects/ productivity enhancement with
PE/Project department.
Established bye- product recovery in co-ordination with PE & PD team for cost
reduction.
Proven mentor in grooming the new (Raw Talents) to the Best Performers.
Training
Attended Inplant Training on
Training on SAP ERP module at Lupin,HO- Mumbai.
Training at UDCT, Mumbai “ Engineering for non engineers” .
Training on Industrial Risk analysis through ISRS (Industrial Sustainability
Rating System).
Personal Vitae
Date of Birth : 22nd September 1966
Languages : English, Hindi, Marathi, Gujarati
Hobbies : Cricket, Indian music, Chess.
References
1) Sachin R. Malekar
Deputy GM (Process Engg.): IPCALab, Mumbai.
2) Mr. Mangesh Padgaonkar,
Senior GM (Production)-Lupin Ltd, Tarapur .