This document provides a summary of an individual's experience and qualifications for an executive management role in research and process development. Some key points:
- Over 21 years of experience in R&D, process development, cost analysis, and product development for APIs, drug intermediates, and specialty chemicals.
- Demonstrated skills in managing R&D teams, designing experiments, optimizing and validating processes, technology transfer, and troubleshooting.
- Published 11 research papers and filed 2 patents related to developing APIs and drug intermediates.
- Previous roles include managing R&D centers and projects for various pharmaceutical companies. Developed over 50 products including APIs that have been commercialized.
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.
APIT, OPTIMISATION ,SCALE UP ,WORK UP, GREEN CHEMISTRY ,MSSDS, SOLVENT SELECTION, EFFLUENT TREATMENT AND MINIMISATION ,HEALTH HAZARD AND SAFETY HAZARD, IN PROCESS CONTROL
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
In vitro antioxidant, antimicrobial and cytotoxic activities of the various e...Akhil Gupta
The present study was designed to investigate antioxidant, antimicrobial and cytotoxic potential of pet ether, chloroform and methanol extracts of Ganoderma lucidum available in Bangladesh.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
The Essentials of USP chapter 51 antimicrobial effectiveness testingGuide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
APIT, OPTIMISATION ,SCALE UP ,WORK UP, GREEN CHEMISTRY ,MSSDS, SOLVENT SELECTION, EFFLUENT TREATMENT AND MINIMISATION ,HEALTH HAZARD AND SAFETY HAZARD, IN PROCESS CONTROL
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
In vitro antioxidant, antimicrobial and cytotoxic activities of the various e...Akhil Gupta
The present study was designed to investigate antioxidant, antimicrobial and cytotoxic potential of pet ether, chloroform and methanol extracts of Ganoderma lucidum available in Bangladesh.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
The Essentials of USP chapter 51 antimicrobial effectiveness testingGuide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
Webquest celebrations around the worldClaudia Soto
This WebQuest deals with celebrations around the world. Four of the most known celebrations will be compared and contrasted so that in the end the students could create their own celebration.
Perangkat Pembelajaran Kurikulum 2013 | Bahasa Inggris kelas 7 | MTS Rasyid Al-Ghazaly
Perangkat pembelajar Kurikulum 2013 untuk tingkat SMP/MTs dengan mata pelajaran Bahasa Inggris untuk kelas 7.
Sementara ini saya upload untuk semester satu. Tunggu untuk materi pada semester dua. Thanks.
6 3-2016 regulatory affairs entry level resume bum kimBum Kim
I find it very difficult to get my first step in the door for my Regulatory Affairs Career, but I am sure that I will be a very successful Regulatory Affairs Professional once I can get started with my first job!!! Knocking on the opportunities right now!!!
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
1. 1
Executive Management: Research and Process Development for APIs, Drug intermediates and
Specialty chemicals
Accomplished professional with over 21 years of distinguished experience in:
Research & Development; Cost Reduction Analysis; Product Development for APIs;
Custom Synthesis; Technology Development and Strategic Planning
Demonstrated competence in executing a wide gamut of functions viz. process management,
process scale up studies, process documentation and co-ordination with QA/RA in
generating DMF (for API’s) etc.
Expert in identifying, collecting, processing, analysing and cataloguing data according to
established protocol, procedures & standards, as appropriate to specific objectives of the
research study
Recognized for having managed 11 Research Publications and filed 2 Indian Patents for
granting patent rights
Demonstrated acumen in developing various Active Pharmaceutical Ingredients (API’s),
drug intermediates, custom synthesis products, specialty chemicals and few natural products
Skilled in steering R&D Team encompassing design of lab experiments, process
development, process optimization, process validation at different stages, transfer of
technologies for commercial scale productions, process costing, process improvement and
troubleshooting
SHIVA PRAKASH.S
No.127, 16th
Main Road, B.S.K 1st
Stage,
2nd
Block, Srinagar, Bangalore 560050
: +91 - 9620372600 / 9448226830
: shivarc127@yahoo.com
2. 2
Proficient in managing:
o A variety of chemical reactions like Grignard Reaction, Mannich Reaction,
Sandmeyer’s, Friedel-crafts Acylation, Wittig Reaction, Hofmann Rearrangement,
Darzen’s Reactions, Strecker Synthesis, etc.
o Sulfonation, Nitration, Halogenation, Hydrogenation, Chloromethylation, Cyanide
Reactions etc.
Sound in-depth theoretical and practical knowledge in synthestic organic chemistry which
could help me to develop new products and processes
Conversant with:
o Searching literature by both manual and online methods using SCIFINDER for
designing synthetic schemes for quick development
o Interpretation of research results to identify and characterize the synthesized compounds
using various analytical techniques like GCMS, NMR, IR, HPLC, GC, etc.
Accomplishments:
Played a vital role in synthesizing more than 50 organic compounds, which include API’s,
drug intermediates, specialty chemicals and few natural products for various applications
o Majority of the products are commercialized
Instrumental in planning and developing several custom products, commercialized and
supplied as per the customer requirement
Executed time bound projects
Bestowed with the Excellence Performance Award for the year 1996-97 from the
management of Recon Ltd., Bangalore, India for outstanding contribution
Formulated cis-cinnarizine, cis-flunarizine and cis-clocinizine for the first time (Ph.D work).
These are counterparts of well-known antihistamine drugs viz., Cinnarizine, Flunarizine and
Clocinizine that possess trans-geometry.
3. 3
ORGANIZATIONAL EXPERIENCE
Since Oct’08 – Nov 14 with Vittal Mallya Scientific Research Foundation, Bangalore,
Karnataka as Project Leader - Chemical Sciences
Role:
Natural Product Chemistry:
Worked on Neem Products – Extraction, Isolation of active component of neem and
preparation of its water soluble formulations
New water-soluble powder formulation of neem extract was developed and applied for
patent rights (Indian Patent filed on 2010)
Extraction and isolation of Hydroxycitric acid (HCA) from Garcinia combogia rind and
preparation of Hydroxycitric acid lactone at 200g scale
Testicular toxicity study of HCA-Lactones conducted in animal model and published in the
reputed Indian journal
Extraction of cashew nut shell liquid (CNSL) – Experiments conducted at 1.0 Kg batch size.
The active compound ‘anacardic acid’ was isolated. Using this as a starting material, various
new synthetic derivatives were prepared and studied their antibacterial activity (for research
purpose)
Synthetic Chemistry: (Doctoral Degree Work)
Stereoselective synthetic method for producing cis-isomers of Cinnarizine, Flunarizine and
Clocinizine was developed for the first time via Wittig reaction and studied their biological
importance
Seven new cis-anologs of cinnarizine were prepared and studied their anticancer potential
Synthesized 2, 4, 5-timethoxy stilbene derivatives by Wittig method and studied their
phytopathogenic effect
Prepared several new stilbenes having pyridine moiety and studied their biological
importance
Attempted a new synthetic method for the preparation of trans-Resveratrol- a naturally
available antioxidant
4. 4
Mar’06 – Sep’08 with Sanmar Specialty Chemicals Ltd., Hosur, Tamil Nadu as Executive
Manager - R&D
Role:
Headed four-memberd team; Reporting to VP -R &D
Ensured preparation of process costing at different stages and updated fortnight / monthly
reports
Resolved findings of review meeting; liaised with inter departments for timely completion
of projects and overall technical support to production team when ever needed
Developed following products from Kilogram level to bulk quantities based on customer
requirement
Drug Intermediates:
S-2-Aminobutanamide HCl (Levitiracetam intermediate) -1 Kg
5, 6, 7, 8-Tetrahydro quinoline-8-one -2Kg
CD675 – Scale up study of customer process (Under phase-3 trial), supplied -200kg
3, 4 Dichlorobenzyl cyanohydrine o-THP
2-Fluoro acetophenone -1Kg
Methyl-alpha-Bromo-2- chloro phenyl acetate (Clopidogrel intermediate)
N-Methyl 2- nitro aniline- Commercialized (> 50 MT)
Mebeverine intermediates; Commercialized (>50 MT)
Indole-3-carboxylic acid,
2-Allyloxy phenol
3-methoxy tyramine (AE phenol) – worked for Syngenta; Set up a new plant for regular
production
Tri hydroxyl phenyl ethane (THPE)
Tris-(2-aminoethyl) amine
4-n-Propylcyclohexanone, etc.
Jul’04 – Mar’06 with Hikal Ltd., Jigani, Bangalore as Scientist-I - Process Development Lab
Role:
Headed process development lab of team comprising of 4 members
Provided technical support to production teams for ongoing plant batches
5. 5
Carried out troubleshooting analysis and new products development in accordance to
business interest
Worked API’s and intermediate:
o Gabapentin
o AcebutalolHCI
o Gemfibrozil
o Cinnarazine
o Theo Bromine
o 1-Cyclo-2-hexenone
Jan’04 – Jun’04 with Syngene International Pvt. Ltd., Bangalore as Executive Scientist
Role:
4-Piperidine-2-ethanol – Process developed, prepared and supplied 2 kg of this material to
Aldrich chemicals.
Jun’01 – Dec’03 with Hikal Ltd., Bangalore as Group Leader- R&D Centre
Role:
Steered team comprising of 3 members and developed synthetic procedures for the following
API’s, drug intermediates and custom products from lab scale to commercial productions
API’s
o Bupropion HCI, an “antidepressant” drug and its impurities as per USP – Regular
production
o Risedronate Sodium – drug used for bone related problems, 100kgs
o Suramine Sodium-Intermediate – 5kgs
o Intermediates / Custom synthesis
o 5, 7-Dimethyl Isatin -10kg
o 4-Benzyloxyaniline HCl - 300kgs
o Cyclohexylbenzene- 2MT
6. 6
o Benzonitrile-3-Acetyl -5Kgs
o 3-Nitro-2.2.2-Trifluoroacetophenone - 100kgs
o 5-Bromo-2-Chloroanisole(CBA)-2MT
o Diethyloxomalonate-10Kgs
o 4-Chloromethyl-3.5-dimethylisoxazole-10kgs
o 2.4-Dinitroimidazole- 200gms
o 4-Amino-1.3.5-trimethyl pyrazole – 2kgs and
o 4-Nitro 2-trifluoromethyl benzonitrile -2kgs
o 2-Amino-3-methyl-5-chlorobenzoicacid – Process developed, scaled up to plant batches,
200kg material supplied to ‘Dupont’ along with tech pack details.
PREVIOUS EXPERIENCE
Apr’00 – May’01 with Rallis (India) Ltd., Bangalore as Research Officer-Pharma R&D
o 6-Methyl-3, 4-Methylene dioxy benzyl chloride - Supplied 300 Kgs
o 5-chloro-2-methyl Indol - Supplied 5Kgs
Mar’95 – Mar’00 with Recon Ltd, Bangalore as Assistant Manager- R&D Centre
o Api’s: Ondonsteron HCl; Nabumetone; Ambroxal; Pentoxyfyline; Sertraline HCl;
Sulfadiazine Sodium and Meloxicam
o Custom’s products: 4-Phenyl-2-oxazolidinone; 4-Benzyl-2-oxazolidinone; 5-amino-2-
methyl Indol; 4R, 5S-1, 5-dimethyl-4-Phenyl-2-Imidazolidinone and its (N-Propenoyl)
derivatives
Jul’93 – Jan’95 with ASTRA-IDL Ltd., Bangalore as Research Associate
o Worked on Prostaglandin intermediates (Carboprost) (15-Me-PGF2α).
7. 7
PUBLICATIONS
1. ‘Issue of testicular toxicity of hydroxycitric acid lactone’, D. Ranjith, S. ShivaPrakash, A.
C. Karunakara, Latha Diwakar and G. Chandrasekara Reddy. Current Science 2011, 100(1),
24-27
2. ‘Synthesis of Mitoxantrone Analogues and in-vitro Cytotoxity’, P. Hareesh Kumar, S. Shiva
Prakash, S. Krishna Kumar, Latha Diwakar and G. Chandrasekara Reddy. International
Journal of Chem.Tech. Research 2011, 3(2), 690-694
3. ‘Stereoselective synthesis of (Z)-1-benzhydryl-4- cinnamylpiperazines via the Wittig
reaction’, Shivaprakash. S, Reddy G. C. Syn.Comm. 2014, 44, 600-609
4. ‘(Z)-1-Diphenylmethyl-4-(3-phenylprop-2-enyl) piperazine’, S. Shivaprakash, G.
Chandrasekara Reddy and Jerry P. Jasinski. Acta Cryst. Section E 2014, E70, o576
5. ‘1-[Bis(4-fluorophenyl)methyl]-4-[(2Z)-3-phenylprop-2-en-1-yl]piperazine-1,4-dium
dichloride hemihydrate’, S. Shivaprakash, G. Chandrasekara Reddy and Jerry P. Jasinski.
Acta Cryst. Section E 2014, E70, o694-o695
6. ‘In vivo studies of (Z)-1-benzhydryl-4- cinnamylpiperazines as anti-inflammatory and
analgesics’ S. Shivaprakash, Anaxee Burman, Latha Diwakar and G. Chandrasekara
Reddy. Int. J. Pharmacy 2014, 4(3), 154-157
7. ‘Synthesis of (E) Stilbenes from 2, 4, 5-Trimethoxybenzyltriphenyl phosphonium Ylide and
their Fungicidal Activity’ S. Shivaprakash, Rajendra Hegde and G. Chandrasekara Reddy.
Am. J. Pharmtech. Res. 2014, 4(5), 146-157
8. ‘Acute Toxicity study of (Z)-1-benzhydryl-4-cinnamylpiperazines in Swiss albino mice’
Anaxee Barman, S. Shivaprakash, Latha Diwakar and G. C. Reddy. Asian J Pharm Clin
Res. 2015, 8(1), 223-224
9. ‘Synthesis and in-vitro study of novel (Z)-1-benzhydryl-4-cinnamylpiperazine derivatives as
potential anticancer agents’ S. Shivaprakash, K. R. Kiran, Latha Diwakar, G.
Chandrasekara Reddy. Int J Pharm Pharm Sci. 2015, 7(1), 416-420
10. ‘Stilbene heterocycles: Synthesis, antimicrobial, antioxidant and anticancer activities’ S.
Shivaprakash, Latha Diwakar and G.Chandrasekara Reddy. The Pharma Innovation
Journal 2015, 3(12), 24-30.
11. ‘A sterically congested cis-stilbene and its phosphonium salt precursor’ Shivanna
Shivaprakash, G. Chandrasekara Reddy, Jerry P. Jasinski, Sean P. Millikan, Courtney E.
Duff and Christopher Glidewell* Acta Crystallographica Section C 2015, C71, 479-484.
8. 8
PATENTS
o Water soluble powder formulation of enriched Azadirachtin and its process thereof -
Shivanna Shivaprakash, Pasupulati Anilkumar, Anilkumar Kush, Goukanapalli
Chandrasekara Reddy; Indian patent filed on July 2010
o Process for isolation of Azadirachtin from neem seed - Shivanna Shivaprakash,
Karunakara, Anil Kumar Kush, Goukanapalli Chandrasekara Reddy; Indian patent filed on
July 2014
EDUCATION
Ph.D (Synthetic Organic Chemistry with Medicinal values)
Thesis titled ‘Synthesis and Biological Evaluation of 1, 4-Disubstituted Piperazine and
Stilbene Compounds’. June 2015, University of Mysore, Mysore, India.
M.Sc. Organic Chemistry – Got master’s degree in the year 1993(1st class), Studied Organic
Chemistry as a major subject, Central College, Bangalore University, Bangalore, India
M.Sc. Mathematics – Central College, Bangalore University, Bangalore, India. (1990-91 but
discontinued in the 2nd year)
B.Sc. Physics, Chemistry and Mathematics – Got bachelor’s degree in the year 1990(1st
class), Bangalore University, Bangalore, India.
Additional course: One year full time certificate course on ‘Post graduation Diploma in
Computer Applications’ completed and received course certificate in the year 1986
REFERENCES
Provided on request
.