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Suresh G. Shinde
(SENIOR BIOTECHNOLOGY/ FERMENTATION INDUSTRY PROFESSIONAL)
Address: K-302,ParksydeResidency,Near Guru Govind School/College,Indira Nagar Annex,
Pathardi Road, Nashik (MH) –422010.09766108804, 09604271061.
sureshshinde1067@gmail.com, microsurman@yahoo.co.in,Web : www.biotradeindia.com
“25 years progressive experience in full-cycle of upstreamand downstream development process encompassing new biological
molecules”. Background in R&D environment ranging from early work as Technical Head to managing global business budget,
covering biology, chemistry, application, and product output.
Skilled leader and team builderexperienced working in cross-functional teams on project management, capacity management,
human resources,business development,legal issues,procurement, etc.
Key Areas of Expertise:
 Downstream and Upstream Processing for Bacterial, Fungal and Yeast fermentation,
 USFDA, cGMP, GLP, and ISO Guidelines, WHO,HALAL,KOSHERTrainings
 Design of Experiments (DOE) and modelling.
 Production, Pilot Plant R&D, Microbiology, Process development and scale-up of fermentation.
 Process control through PLC, SCADA, DCS, etc..
 Process Modeling, Monitoring & Statistical Data Analysis.
 Process Optimization, Scale-up, and Validation Studies for Bio manufacturing of Products, including Enzymes, Cell
culture, probiotics and Proteins
 Enzyme Culture, Recombination and Microbial Fermentation
 Batch and Fed-Batch Stirred Tank Bioreactor Operation and Troubleshooting
 Membrane Filtrations (Ultrafiltration, Nano filtration, Microfiltration and Cross Flow Filtration)
 Purification and Drying by Spray dryer, Lyophilizer, Tray dryer and FBD operations.
 Enzyme Analysis and Characterization (HPLC, UV-vis Spectrophotometry, Densitometry Analysis)
 Documentation Systems (Lab Documents, SOPs, BPRs, Process Validation, Quality Control, Technical Reports,
Technology Transfer, Expense Budgets, Work Orders and Purchasing Systems)
Specialties:Project and Operations Management in Fermentation, GeneralManagement of the Fermentation Plant,
Process development from Lab Scale to Plant level, Enzyme production and Its Applications.
PRODUCT EXPERTISE THROUGH FERMETATION
Biological Molecules: Rifamycin B, Lovastatin, Cephalosporin
Enzymes:Cellulase,Serratiopeptidase,Acid Protease,Papain, Fungal Protease,Xylenase,Alkaline Protease, Lactase, Pectinase,
Amylase, Glucoamylase,Bact Amylase, Catalase,Yeast Lipase, Bact. lipase etc...
Probiotics:Saccharomyces boulardii,Lactobacillus sporugens,Bacillus Spp. Essential microbes production for Agricultural uses.
Biosurfactant production (Sophorolipids) etc…
PERSONAL DETAILS
Sex : MaleDate of Birth: 2nd June 1967
Place of Birth : Osmanabad(MH)Languages Known: Marathi, Hindi & EnglishMaritalStatus: MarriedNationality : Indian
Present Salary : 15 LPA Salary Expectation: Negotiable
Present Location : Nashik Relocation Preferred:Anywhere
EDUCATIONAL QUALIFICATION:
B.Sc. Microbilogy-1990-Zadbuke Mahavidyalaya- Shivaji University Kolhapur
M. Sc. (Industrial Microbiology)-1992 – YashwantraoChavanScience Collage, Shivaji University Kolhapur.
WARDSAnd PERFORMANCES:
Two times best performance award in Lupin Chemicals Ltd. Tarapur.
One time best skill and performance award with highest incentive in ABTL Nashik
COMPUTER/SOFTWARE SKILLS:
MOD-300 DCS Operation Training by ABB Banglore,
Basic knowledge of Computer and SAP and Orion related software’s for systemoperations.
MS office, PowerPoint preparation, Graphical presentation of data, SCADA software operations for batches control,
PLC base controls of fermentation batches etc..
PROFESSIONAL EXPERIENCE:
Shift Incharge-Fermentation(Sep 1992-May 2000)-LupinLaboratories Ltd.Tarapur
 To handle the complete activities in fermentation section by DCS monitoring plant.
 Improve the Quantity and Quality of products.
 Maintain the sterility of fermentation batches.
 Enzyme purification, extraction and recovery activities.
 Complete planning of the Fermentation batches and Recovery section.
 Awareness of cGMP compliances.
 Documents as per cGMP and ISO norms.
 Scale up Studies of various products.
 Conduct Audits of ISO and cGMP Authorities.
 To prepare the USFDA, cGMP records as per there requirements.
 To prepare the action plans for various activities, i.e. contamination batches,failures and OOS batches.
 A complete operation of process was controlled by MOD-300 DCS system.
 Achieving the production targets as per instruction by higher management.
 To maintained sterilities of batches,taking preventive measures to avoid Contamination.
 To handle the whole health care unit responsibilities independently.
 To prepare new sops as per changes,prepare USFDA documentation.
 As a core team member handled and successfully implemented of new technology and set up.
 Handling fermented capacity from 30 lit to 100000 lit with fully automation.
Asst Manager-Operation (From Mar 2003- May 2010)-Advanced Enzyme Technologies Limited- Nashik
 Planning to all activities in Specified section of production Areas like fermentation, Purification, Formulation and
Packing areas. I have responsible for the set the target for production according to market demand. Preparing of day to
day plan, and also manpower management.
 Preparation & implementation of SOPs, Monitoring of ISO, cGMP aspects in shop floor, Online completion of batch
records &GMP records.
 Leading production team to carry the production and formulation activities & achieve targets Supervision of routine
production operations,meeting production targets.
 Coordination with client parties regarding their requirements, Quality production,schedules implementing and timely
deliveries of production.
 Handling change controls, Out of Specifications (OOS), Deviations, and Rejected materials and co-ordination with QA
 Preparation & successfully presented the production facility during international regulatory audits and compliance of the
same.
 Special attention to export products for timely delivery with quality.
 Coordination with Quality Control, Quality Assurance,Warehouse,Engineering, personneldepartments to ensure
availability of all components / resources required for smooth production in packing dept.Initiate quality improvements,
cost manpower reduction measures through process / other modification. Assure production activities are carried out
within the department as per the cGMP guidelines.
 Confirm compliance checks during production and ensure that first time quality is achieved during manufacturing
processes.
 Monitoring of fermentation production and controls,finished goods quality, Minimize market complaints, packaging
quality etc.
 Management of consumables (including changeoverparts & spares)and packing material consumption.
 Installation and Commissioning of various equipment’s i.e. fermentors, purification equipment’s, Evaporation Plant,
Spray dryer, Lab Fermenters, Pilot Plant set up, Separator, Decanters, Lyophilize, Octagonal blender, RMG and various
packing machines, CMS etc.
Production Head-Pharma(Jun 2010 -Feb 2013)-Rossari BiotechLtd – Silvassa
 To start the company from basic infrastructure preparation and set up the four plant within two years with huge quantity
of production i.e Fermentation, Purification, Biotech lab, Pharma Formulation and AHN formulations.
 As part of the project, developed and implemented all reports to develop the new product and method of fermentation
technology and submit to financial departments.
 Spearheads this ongoing consulting firm that was grounded in product innovation, development, marketing and
distribution.
 Complete Biotech set up handling the complete project for Enzymes mfg headed by DBT.(BIPP).
 Documentation and implemented licensing authorities of FDA/ISO/WHO/HALAL/KOSHER etc.
 Fermentation set up and to run the successive project of DBT for enzyme production.
 To handle the multi product line on various formulation and set up new formulations for Animal and food sectors.
 Documentation and implementation of SOP in newly organization to run the smooth operations.
 To handle the complete Health care activities Includes Pharma applications, Animal Health nutrition and Biotech
Activities with fermentation technologies.
 Developing regulatory concept in each and every individual working in the industry.
 Development of new products with minimum non-compliances for submitting more fermentation base products to
achieve demand of health care industry and EXPORT product.
 To develop skills of personnelin department to face any type of external audits.
 To make all the work processes to be online and atomized.
 Minimize customer complaints related to Quality of the product.
General Manager-Operations( Feb 2013-Jan 2014)-Sequence BiotechPvt Ltd-Nashik
 Complete set up the Enzyme mfg plant with installation of proper machines and process standardization.
 Fermentation plant set up and commercial trials for various enzymes.
 Complete R & D section handling for scale up and process optimization of fermentation base enzymes production.
 Design and Develop the Enzyme Application product for Following Sectors:
1. Animal Feed Supplement
2. Starch/Sugar Industry
3. Detergent and Textile Industry
4. Biogas Industry
5. Leather Industry
6. Paper and Pulp Industry
7. API/Pharma Enzyme Applications
8. Waste Management
 Created and developed new vendors for Fermentation RM and formulation critical RM.
 Direct reporting to Director Technical or Managing director.
 To develop and standardize the analytical methods for various enzymes.
 Complete Business Handling as a Site Head up commercialization.
 Evaluated company strategy and growth potential; developed marketing initiatives to generation of markets and sales.
Technical Head-Biotech(FromApril 2014–Dec-2014)-Alliance Enzymes Pvt Ltd. Surat
 Biotech Research and Project Management –
 Provide technical and management expertise and leadership.
 Customer relation’s management and other professionaland institutional relationship development and management.
 Successfully managed over projects/programs to client satisfaction and meeting fiscal profits through supervisory and
support personnelnumbering.
 Strategic leadership in the planning, acquisition, marketing and sales efforts resulting in millions in revenue and fiscal
profits.
 Executive leadership and active participation in client management resulting in 20% increase in client/customer retention
and 10% increase in new client/customer acquisitions.
 Designed, implemented and installed new enzyme manufacturing facility
 Productized prototype distributed system.
 Maintained performance and stability of multi-process, multi-threaded text analyzer.
 Selected open-source packages to be integrated into the product offering
 Improves quality of Papain production and increase of yield up to 15 % with new state up art technology and product is
approved by worldwide customers.
 Visited to South African countries i.e Uganda, Tanzania, and Kenya for Product survey and trials.
 More than 10 Successful audits for International customers.
 Vendor and Suppliers development for RM and Chemicals.
BiotradeIndia Consultancy -(SS Trading Co. Nashik-Waste Management and Enzyme Specialist):(from Jan 2015 to till date)
 Working as a free-lancer for solution of all biotechnological solutions for any biological molecules and enzymes.
 Enzyme: manufacturing set up, Commercial trials and technological support with complete technical knowhow.
 Waste Management: Enzyme formulation and complete solution for decomposing and waste treatment.
 Complete solution for Biological production and troubleshooting during process.
 Complete process designing and optimization of products.
 cGMP set up as per API norms and documentations.
 Training for personneland guide as per GLP/GMP norms.
 Complete technological support for enzyme production.
 Pilot plant for R n D trials and small batches.
 Current Project: Food Waste/Chicken Waste/Tannery Waste Management,Bio fertilizer /Enzyme/Probiotics
productions..
Place: Nashik
(Sign)
Suresh G Shinde.

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Suresh Profile

  • 1. Suresh G. Shinde (SENIOR BIOTECHNOLOGY/ FERMENTATION INDUSTRY PROFESSIONAL) Address: K-302,ParksydeResidency,Near Guru Govind School/College,Indira Nagar Annex, Pathardi Road, Nashik (MH) –422010.09766108804, 09604271061. sureshshinde1067@gmail.com, microsurman@yahoo.co.in,Web : www.biotradeindia.com “25 years progressive experience in full-cycle of upstreamand downstream development process encompassing new biological molecules”. Background in R&D environment ranging from early work as Technical Head to managing global business budget, covering biology, chemistry, application, and product output. Skilled leader and team builderexperienced working in cross-functional teams on project management, capacity management, human resources,business development,legal issues,procurement, etc. Key Areas of Expertise:  Downstream and Upstream Processing for Bacterial, Fungal and Yeast fermentation,  USFDA, cGMP, GLP, and ISO Guidelines, WHO,HALAL,KOSHERTrainings  Design of Experiments (DOE) and modelling.  Production, Pilot Plant R&D, Microbiology, Process development and scale-up of fermentation.  Process control through PLC, SCADA, DCS, etc..  Process Modeling, Monitoring & Statistical Data Analysis.  Process Optimization, Scale-up, and Validation Studies for Bio manufacturing of Products, including Enzymes, Cell culture, probiotics and Proteins  Enzyme Culture, Recombination and Microbial Fermentation  Batch and Fed-Batch Stirred Tank Bioreactor Operation and Troubleshooting  Membrane Filtrations (Ultrafiltration, Nano filtration, Microfiltration and Cross Flow Filtration)  Purification and Drying by Spray dryer, Lyophilizer, Tray dryer and FBD operations.  Enzyme Analysis and Characterization (HPLC, UV-vis Spectrophotometry, Densitometry Analysis)  Documentation Systems (Lab Documents, SOPs, BPRs, Process Validation, Quality Control, Technical Reports, Technology Transfer, Expense Budgets, Work Orders and Purchasing Systems) Specialties:Project and Operations Management in Fermentation, GeneralManagement of the Fermentation Plant, Process development from Lab Scale to Plant level, Enzyme production and Its Applications. PRODUCT EXPERTISE THROUGH FERMETATION Biological Molecules: Rifamycin B, Lovastatin, Cephalosporin Enzymes:Cellulase,Serratiopeptidase,Acid Protease,Papain, Fungal Protease,Xylenase,Alkaline Protease, Lactase, Pectinase, Amylase, Glucoamylase,Bact Amylase, Catalase,Yeast Lipase, Bact. lipase etc... Probiotics:Saccharomyces boulardii,Lactobacillus sporugens,Bacillus Spp. Essential microbes production for Agricultural uses. Biosurfactant production (Sophorolipids) etc… PERSONAL DETAILS Sex : MaleDate of Birth: 2nd June 1967 Place of Birth : Osmanabad(MH)Languages Known: Marathi, Hindi & EnglishMaritalStatus: MarriedNationality : Indian Present Salary : 15 LPA Salary Expectation: Negotiable Present Location : Nashik Relocation Preferred:Anywhere EDUCATIONAL QUALIFICATION: B.Sc. Microbilogy-1990-Zadbuke Mahavidyalaya- Shivaji University Kolhapur M. Sc. (Industrial Microbiology)-1992 – YashwantraoChavanScience Collage, Shivaji University Kolhapur. WARDSAnd PERFORMANCES: Two times best performance award in Lupin Chemicals Ltd. Tarapur. One time best skill and performance award with highest incentive in ABTL Nashik COMPUTER/SOFTWARE SKILLS: MOD-300 DCS Operation Training by ABB Banglore, Basic knowledge of Computer and SAP and Orion related software’s for systemoperations. MS office, PowerPoint preparation, Graphical presentation of data, SCADA software operations for batches control, PLC base controls of fermentation batches etc..
  • 2. PROFESSIONAL EXPERIENCE: Shift Incharge-Fermentation(Sep 1992-May 2000)-LupinLaboratories Ltd.Tarapur  To handle the complete activities in fermentation section by DCS monitoring plant.  Improve the Quantity and Quality of products.  Maintain the sterility of fermentation batches.  Enzyme purification, extraction and recovery activities.  Complete planning of the Fermentation batches and Recovery section.  Awareness of cGMP compliances.  Documents as per cGMP and ISO norms.  Scale up Studies of various products.  Conduct Audits of ISO and cGMP Authorities.  To prepare the USFDA, cGMP records as per there requirements.  To prepare the action plans for various activities, i.e. contamination batches,failures and OOS batches.  A complete operation of process was controlled by MOD-300 DCS system.  Achieving the production targets as per instruction by higher management.  To maintained sterilities of batches,taking preventive measures to avoid Contamination.  To handle the whole health care unit responsibilities independently.  To prepare new sops as per changes,prepare USFDA documentation.  As a core team member handled and successfully implemented of new technology and set up.  Handling fermented capacity from 30 lit to 100000 lit with fully automation. Asst Manager-Operation (From Mar 2003- May 2010)-Advanced Enzyme Technologies Limited- Nashik  Planning to all activities in Specified section of production Areas like fermentation, Purification, Formulation and Packing areas. I have responsible for the set the target for production according to market demand. Preparing of day to day plan, and also manpower management.  Preparation & implementation of SOPs, Monitoring of ISO, cGMP aspects in shop floor, Online completion of batch records &GMP records.  Leading production team to carry the production and formulation activities & achieve targets Supervision of routine production operations,meeting production targets.  Coordination with client parties regarding their requirements, Quality production,schedules implementing and timely deliveries of production.  Handling change controls, Out of Specifications (OOS), Deviations, and Rejected materials and co-ordination with QA  Preparation & successfully presented the production facility during international regulatory audits and compliance of the same.  Special attention to export products for timely delivery with quality.  Coordination with Quality Control, Quality Assurance,Warehouse,Engineering, personneldepartments to ensure availability of all components / resources required for smooth production in packing dept.Initiate quality improvements, cost manpower reduction measures through process / other modification. Assure production activities are carried out within the department as per the cGMP guidelines.  Confirm compliance checks during production and ensure that first time quality is achieved during manufacturing processes.  Monitoring of fermentation production and controls,finished goods quality, Minimize market complaints, packaging quality etc.  Management of consumables (including changeoverparts & spares)and packing material consumption.  Installation and Commissioning of various equipment’s i.e. fermentors, purification equipment’s, Evaporation Plant, Spray dryer, Lab Fermenters, Pilot Plant set up, Separator, Decanters, Lyophilize, Octagonal blender, RMG and various packing machines, CMS etc. Production Head-Pharma(Jun 2010 -Feb 2013)-Rossari BiotechLtd – Silvassa  To start the company from basic infrastructure preparation and set up the four plant within two years with huge quantity of production i.e Fermentation, Purification, Biotech lab, Pharma Formulation and AHN formulations.  As part of the project, developed and implemented all reports to develop the new product and method of fermentation technology and submit to financial departments.  Spearheads this ongoing consulting firm that was grounded in product innovation, development, marketing and distribution.  Complete Biotech set up handling the complete project for Enzymes mfg headed by DBT.(BIPP).  Documentation and implemented licensing authorities of FDA/ISO/WHO/HALAL/KOSHER etc.  Fermentation set up and to run the successive project of DBT for enzyme production.  To handle the multi product line on various formulation and set up new formulations for Animal and food sectors.  Documentation and implementation of SOP in newly organization to run the smooth operations.  To handle the complete Health care activities Includes Pharma applications, Animal Health nutrition and Biotech Activities with fermentation technologies.  Developing regulatory concept in each and every individual working in the industry.  Development of new products with minimum non-compliances for submitting more fermentation base products to achieve demand of health care industry and EXPORT product.
  • 3.  To develop skills of personnelin department to face any type of external audits.  To make all the work processes to be online and atomized.  Minimize customer complaints related to Quality of the product. General Manager-Operations( Feb 2013-Jan 2014)-Sequence BiotechPvt Ltd-Nashik  Complete set up the Enzyme mfg plant with installation of proper machines and process standardization.  Fermentation plant set up and commercial trials for various enzymes.  Complete R & D section handling for scale up and process optimization of fermentation base enzymes production.  Design and Develop the Enzyme Application product for Following Sectors: 1. Animal Feed Supplement 2. Starch/Sugar Industry 3. Detergent and Textile Industry 4. Biogas Industry 5. Leather Industry 6. Paper and Pulp Industry 7. API/Pharma Enzyme Applications 8. Waste Management  Created and developed new vendors for Fermentation RM and formulation critical RM.  Direct reporting to Director Technical or Managing director.  To develop and standardize the analytical methods for various enzymes.  Complete Business Handling as a Site Head up commercialization.  Evaluated company strategy and growth potential; developed marketing initiatives to generation of markets and sales. Technical Head-Biotech(FromApril 2014–Dec-2014)-Alliance Enzymes Pvt Ltd. Surat  Biotech Research and Project Management –  Provide technical and management expertise and leadership.  Customer relation’s management and other professionaland institutional relationship development and management.  Successfully managed over projects/programs to client satisfaction and meeting fiscal profits through supervisory and support personnelnumbering.  Strategic leadership in the planning, acquisition, marketing and sales efforts resulting in millions in revenue and fiscal profits.  Executive leadership and active participation in client management resulting in 20% increase in client/customer retention and 10% increase in new client/customer acquisitions.  Designed, implemented and installed new enzyme manufacturing facility  Productized prototype distributed system.  Maintained performance and stability of multi-process, multi-threaded text analyzer.  Selected open-source packages to be integrated into the product offering  Improves quality of Papain production and increase of yield up to 15 % with new state up art technology and product is approved by worldwide customers.  Visited to South African countries i.e Uganda, Tanzania, and Kenya for Product survey and trials.  More than 10 Successful audits for International customers.  Vendor and Suppliers development for RM and Chemicals. BiotradeIndia Consultancy -(SS Trading Co. Nashik-Waste Management and Enzyme Specialist):(from Jan 2015 to till date)  Working as a free-lancer for solution of all biotechnological solutions for any biological molecules and enzymes.  Enzyme: manufacturing set up, Commercial trials and technological support with complete technical knowhow.  Waste Management: Enzyme formulation and complete solution for decomposing and waste treatment.  Complete solution for Biological production and troubleshooting during process.  Complete process designing and optimization of products.  cGMP set up as per API norms and documentations.  Training for personneland guide as per GLP/GMP norms.  Complete technological support for enzyme production.  Pilot plant for R n D trials and small batches.  Current Project: Food Waste/Chicken Waste/Tannery Waste Management,Bio fertilizer /Enzyme/Probiotics productions.. Place: Nashik (Sign) Suresh G Shinde.