Manjunath Dudhanikar Email and Phone Number
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As an experienced Bio-process Technologist, I have dedicated my career to the process development of Bio molecules. My journey in this field has been nothing short of exhilarating, filled with opportunities to learn, experiment, innovate, and commercialize. With over a decade of practical experience, I have honed my expertise in a wide range of specialties, including PI, PC, and scale-up for various essential products such as microbial recombinant therapeutic proteins, vaccines like the nCOVID 19 vaccine and Adenovirus vector vaccine, as well as Monoclonal antibodies and BIOSIMILARS.My passion for problem-solving has been a driving force throughout my career. I take great pride in my ability to troubleshoot issues related to fermentation and purification processes, from the initial stages in the lab to the complex demands of process scale. This hands-on experience has provided me with a deep understanding of the challenges and opportunities within the bio-process technology landscape.Throughout my professional journey, I have had the privilege of working in diverse and dynamic environments. My roles have spanned across various crucial areas, including Research and Development (R&D), Manufacturing Science and Technology (MSAT), Clinical manufacturing, commercial manufacturing, and Techno Commercial marketing cum sales. These experiences have not only broadened my skill set but have also given me a unique perspective on the industry as a whole.In every role I have taken on, I have approached my work with unwavering enthusiasm and a commitment to excellence. The ever-evolving nature of bio-process technology excites me, and I am always eager to embrace new challenges and opportunities for growth. My dedication to stay at the forefront of innovation in this field and I am constantly seeking out new ways to make a meaningful impact.Looking ahead, I am excited about the possibilities that lie ahead in the bio-process technology sector. The potential for groundbreaking advancements and the opportunity to contribute to the development of life-saving products continue to fuel my passion for this work. I am committed to leveraging my expertise and experience to drive positive change and innovation within the industry.In conclusion, my journey as a Bio-process Technologist has been defined by a relentless pursuit of excellence, a passion for innovation, and a deep-seated commitment to making a meaningful impact. I am eager to continue pushing the boundaries of what is possible in this field and am excited about the opportunities that the future holds.
M R Sanghavi & Co.
View- Website:
- mrsanghavico.com
- Employees:
- 7
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Application ConsultantM R Sanghavi & Co. Feb 2022 - PresentPuneApplications, Biotechnology & Engineering process scale up, Operations, Production facilities setup, Equipment commissioning, Process Intensification, Process development & othersMonoclonal Antibodies | Viral Vaccines | Bacterial Vaccines | Live Attenuated Vaccines | Conjugate Vaccines | Adeno associated Virus Vaccine | MultiValent Vaccines | Cell & Gene Therapy | Formulations | Peptides | Small Molecules | CGT | AAV | Adeno associated Virus Vaccine | Insulin & Analogues -
Deputy ManagerSerum Institute Of India Pvt. Ltd. May 2021 - Feb 2022Pune, Maharashtra, IndiaVersatile team lead for Process Development & cGMP CT batches ensuring timeline❖ Responsible for DSP & USP process development of mAbs using mammalian cell culture system❖ Engaged as DSP plus USP lead with COVID 19 vaccine project (Oxford’s ChAdOx nCOV-19 or AZ 1222) -
Assistant ManagerSerum Institute Of India Limited Aug 2017 - Apr 2021Pune Area, IndiaTeam lead for DSP TEAM (support USP) handling projects individually from process optimization using statistical tools (DOE) to clinical manufacturing as per cGMP regulatory guidelines (including IPQC for in process samples)MOLECULES & Projects: mAbs, nCOVID 19 vaccine, antibodies Scale: 3L to 2Kl bioreactor output + purification processExpertise in downstream process development, clinical manufacturing & purification process intensification (PI) and trouble shooting of… Show more Team lead for DSP TEAM (support USP) handling projects individually from process optimization using statistical tools (DOE) to clinical manufacturing as per cGMP regulatory guidelines (including IPQC for in process samples)MOLECULES & Projects: mAbs, nCOVID 19 vaccine, antibodies Scale: 3L to 2Kl bioreactor output + purification processExpertise in downstream process development, clinical manufacturing & purification process intensification (PI) and trouble shooting of biotherapeuticsStudied & applied process characterization (PC) & validation (PV) by scaling down the process for various attributes viz. resin lifetime study, virus clearance studies using QbD approachMonitored, participated & executed in cGMP facility design (BOD, VMP, EM, utilities), R&D lab set up equipment qualification (URS, DQ, FRS, FAT, SAT, IQ, OQ, PQ)USP & DSP equipment sizing and selection for bioreactors, chromatography systems, TFF (ultrafiltration and diafiltration), continuous process systems, single use mixers.Scale up and technology transfer upto 2KlActive support in PV & CVProcess automation for USP & DSP equipmentsProcess troubleshooting and investigation with CAPA procedureFacility design changes and facility fitment assessmentFollowing QMS - Author & review BMR, SOPs, protocols, checklists, handle deviations and change control as per process requirement Show less -
Executive OfficerSerum Institute Of India Limited May 2015 - Jul 2017Pune Area, IndiaUSP & DSP Process optimization using statistical tools (DOE), process write up, etc.Monitored, participated & executed in cGMP facility design (BOD, EM, utilities), lab set up and equipment qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ)Inventory management & budgeting using SAP MM modulecGMP documentation practices viz. BMR/BPR preparation, deviation & change control filing IPQC for in process samples using UPLC SEC, UPLC CEX, cIEF, SPR, etc. -
Bioprocess SpecialistGe Healthcare Sep 2013 - Apr 2015Pune Area, India* Evaluation, optimization and recommendation of upstream (Xcellerex bioreactors) & downstream process technologies (Chromatography media, ultrafiltration, microfiltration) for various processes applied in purification of recombinant proteins expressed in Yeast, bacterial as well as mammalian systems, plasma proteins and vaccines.* To carry out feasibility evaluation of various USP & downstream technologies through performance trials / demonstrations at customer site and accordingly provide… Show more * Evaluation, optimization and recommendation of upstream (Xcellerex bioreactors) & downstream process technologies (Chromatography media, ultrafiltration, microfiltration) for various processes applied in purification of recombinant proteins expressed in Yeast, bacterial as well as mammalian systems, plasma proteins and vaccines.* To carry out feasibility evaluation of various USP & downstream technologies through performance trials / demonstrations at customer site and accordingly provide sizing and scale up recommendations for the same.* Assist in implementation of the recommendations based on lab scale evaluations to production or pilot scale & post installation performance demonstration of technologies at pilot and manufacturing scales for Xcellerex bioreactors & purification process (chromatography & MF / UF) * To provide technical support for sales team & value addition by technical cum sales presentation, prepare technical quotations, negotiate win-win situation for both parties by right solutions, process mapping, alternative market development, comparison presentation against competitive product* New purification technologies presentation, demonstration and training. * Trouble-shooting of problems involved in separation and purification processes from lab to process scale.- Research and development expertise in different chromatographic techniques (IEC, GFC, Mixed Mode, Affinity, HIC, RPHPLC).- Proficiency in handling large scale columns (Chromaflow & Axichrom) packing & unpacking - Proficiency in process optimization and handling of various TFF (Cassette, Hollow fiber) unit operations for ultrafiltration or microfiltration of biomolecules at various scales.- Proficiency in handling XDR 10, 50, 200 bioreactors- High throughput process development for chromatography involving resin screening and optimization by 96 well plates Show less -
Bioprocess SpecialistGe Healthcare Apr 2012 - Sep 2013Mumbai Area, IndiaApplication in chromatography process (help design in) Assist in filtrationTrouble shooting in DSP* Evaluation, optimization and recommendation of downstream process technologies (Chromatography media, ultrafiltration, microfiltration) for various processes applied in purification of recombinant proteins expressed in Yeast, bacterial as well as mammalian systems, plasma proteins and vaccines.* To carry out feasibility evaluation of various downstream technologies through… Show more Application in chromatography process (help design in) Assist in filtrationTrouble shooting in DSP* Evaluation, optimization and recommendation of downstream process technologies (Chromatography media, ultrafiltration, microfiltration) for various processes applied in purification of recombinant proteins expressed in Yeast, bacterial as well as mammalian systems, plasma proteins and vaccines.* To carry out feasibility evaluation of various downstream technologies through performance trials / demonstrations at customer site and accordingly provide sizing and scale up recommendations for the same.* Assist in implementation of the recommendations based on lab scale evaluations to production or pilot scale & post installation performance demonstration of technologies at pilot and manufacturing scales.* New purification technologies presentation, demonstration and training. * Trouble-shooting of problems involved in separation and purification processes from lab to process scale. Show less -
Research AssociateWockhardt Jul 2010 - Apr 2012Aurangabad Area, IndiaPart of Process Development & Characterization team for Downstream Process Development of Bio-therapeutic proteins• Downstream process development of recombinant proteins.• Process characterization and Process validation at lab and pilot scale for recombinant protein bio pharmaceuticals adopting QbD approach.• Proposed scale for the plant with the validation of pilot batches.• Involved in manufacturing batches of Active pharmaceutical• Process development for… Show more Part of Process Development & Characterization team for Downstream Process Development of Bio-therapeutic proteins• Downstream process development of recombinant proteins.• Process characterization and Process validation at lab and pilot scale for recombinant protein bio pharmaceuticals adopting QbD approach.• Proposed scale for the plant with the validation of pilot batches.• Involved in manufacturing batches of Active pharmaceutical• Process development for purification of Enzymes• Well acquainted with process development using the Design of Experiment approach using various statistical softwares (Design Expert).• Research and development expertise in optimization of different chromatographic techniques using High throughput screening as well as on column approach.• Expertise in automation of chromatographic runs using UNICORN software.• Research and development expertise in protein refolding from inclusion bodies.• Expertise in enzymatic alteration of proteins• Development and optimization of tangential flow filtration for the concentration, diafiltration of therapeutic proteins.• Perform quantitative analytical methods viz. RP HPLC, total protein estimation & enzyme assay and qualitative analytical method SDS PAGE & IEF analysis Show less
Manjunath Dudhanikar Skills
Manjunath Dudhanikar Education Details
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Institute Of Chemical Technolgy, Mumbai (Udct)Research Student -
Govt. College Of Pharmacy, Karad (Maharastra)Student -
Shri Siddheshwar High School, Solapur (Maharastra)Student
Frequently Asked Questions about Manjunath Dudhanikar
What company does Manjunath Dudhanikar work for?
Manjunath Dudhanikar works for M R Sanghavi & Co.
What is Manjunath Dudhanikar's role at the current company?
Manjunath Dudhanikar's current role is Bioprocess Engineer | ANALYST | Commercialization | Consultant.
What is Manjunath Dudhanikar's email address?
Manjunath Dudhanikar's email address is ma****@****ute.com
What is Manjunath Dudhanikar's direct phone number?
Manjunath Dudhanikar's direct phone number is +191673*****
What schools did Manjunath Dudhanikar attend?
Manjunath Dudhanikar attended Institute Of Chemical Technolgy, Mumbai (Udct), Govt. College Of Pharmacy, Karad (Maharastra), Shri Siddheshwar High School, Solapur (Maharastra).
What are some of Manjunath Dudhanikar's interests?
Manjunath Dudhanikar has interest in Indian Coin Collection, Listening Music, Traveling And Exploring New Places, Playing Violin, Play Basket Ball.
What skills is Manjunath Dudhanikar known for?
Manjunath Dudhanikar has skills like Protein Chromatography, Downstream Processing, Sds Page, Tff, Process Design, Hplc, Refolding, Chromatography, Purification, Biotechnology, V&v, Protein Chemistry.
Who are Manjunath Dudhanikar's colleagues?
Manjunath Dudhanikar's colleagues are Santosh Gaikwad.
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Manjunath Dudhanikar
India
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