Summary
Overview
Work History
Education
Skills
Publications
Timeline
Hi, I’m

Dr. Bhushan Vasant Dabholkar

Dadar

Summary

To pursue a challenging professional career in a dynamic and progressive environment using inherent strength and qualities.

Reliable Technical Director with 30 years leading technology-centric departments to become outstanding contributors. Confident advocate for junior staff members. Enthusiastic about use of technical education to improve business outcomes. Skillful at uniting educationally and geographically diverse teams toward achieving singular goals.

Overview

31
years of professional experience

Work History

Novapure Healthcare Pvt Ltd

Technical Director
01.2018 - Current

Job overview

  • Setting R&D Direction: Define and drive the strategic direction of organic chemistry research, aligning it with company goals, market needs, and emerging scientific trends.
  • Innovation & New Product Development: Lead the conceptualization, design, and development of novel organic compounds, synthetic routes, and chemical processes for new products or applications.
  • Technology Scouting: Identify and evaluate new technologies, methodologies, and analytical techniques relevant to organic chemistry to enhance R&D capabilities and efficiency.
  • Intellectual Property (IP) Strategy: Oversee the protection of intellectual property through patents, trade secrets, and publications, ensuring the company's innovations are safeguarded.
  • Project Management & Execution: Manage a portfolio of complex organic chemistry projects from inception to completion, ensuring they are delivered on time, within budget, and to specified quality standards.
  • Resource Allocation: Optimize the allocation of human, financial, and material resources across various projects.
  • Risk Management: Identify potential technical and operational risks in projects and develop mitigation strategies.
  • Problem Solving: Provide expert guidance and solutions to complex technical challenges encountered during research and development.
  • Team Leadership & Development: Mentor and develop a team of organic chemists, fostering their technical skills, scientific rigor, and career growth.
  • Performance Management: Conduct performance reviews, set objectives, and provide constructive feedback to team members.
  • Recruitment & Training: Participate in the recruitment of scientific talent and ensure ongoing training and professional development for the team.
  • Fostering Collaboration: Promote a collaborative and innovative work environment within the team and across different departments.
  • Quality Assurance & Regulatory Compliance: Establish and enforce high scientific and technical standards for experimental design, data analysis, and reporting in organic chemistry.
  • Safety & Compliance: Ensure all laboratory operations adhere to strict safety regulations, environmental guidelines, and relevant industry standards (e.g., GMP, GLP).
  • Quality Control: Oversee the implementation of robust quality control processes for synthesized compounds and chemical products.
  • Documentation: Ensure meticulous documentation of all research activities, experimental procedures, and results.
  • Technical Expertise & Consultation: Serve as the primary subject matter expert in organic chemistry, providing technical insights and guidance to internal teams and external stakeholders.
  • Troubleshooting: Diagnose and resolve complex chemical synthesis issues, process inefficiencies, and product performance problems.
  • Scientific Communication: Present research findings, project updates, and technical reports to senior management, clients, and scientific communities.
  • Cross-functional Collaboration & External Relations: Collaborate effectively with other departments such as manufacturing, quality control, sales, marketing, and regulatory affairs to ensure seamless product development and commercialization.
  • External Partnerships: Build and maintain relationships with academic institutions, research organizations, and industry partners for collaborative projects, technology transfer, and knowledge exchange.
  • Client & Stakeholder Engagement: Interact with clients and external stakeholders to understand their needs, present technical solutions, and ensure customer satisfaction.
  • Budgeting & Financial Management: Develop and manage the R&D budget for organic chemistry projects and operations.
  • Cost Optimization: Identify opportunities to optimize costs without compromising scientific quality or project timelines.
  • Current Employer

Cogent Life Science Pvt Ltd

Head of Project: API, Intermediates
10.2017 - 01.2018

Job overview

  • Erection of new API Intermediate project at Patalganga MIDC as per C-GMP and USFDA norms.
  • Preparation of plot plan, layouts with detail engineering & Total erection and commissioning of plant and equipment as per process requirements.
  • Implementation of GMP and quality system in API / intermediate manufacturing facility.
  • Selection of molecule considering plant suitability.
  • Technology developed at the bench scale to commercial scale and technology transfer from Laboratory to production scale, Process Validations and process commercialization on plant scale.
  • Internal Audits and vendor audits, Third party manufacturing and vendor development.
  • Preparation and review of Quality System documents such as technology transfer documents, Process development report, BMRs, Standard Operating Procedures, TTD & various technical documents for regulatory agencies (USFDA, EDQM, DCGI) etc.
  • Support for Process modifications for cost effective and troubleshooting of the process.
  • Co-ordination with Quality Control department for the day-to-day process monitoring during manufacturing of API.
  • Co-ordination with Procurement, warehouse dept. for inventory management of raw materials and finished goods.
  • Co-ordination with Regulatory dept. for DMF fillings and related documentation.
  • Previous Employers

Sitec Labs Pvt Ltd

Head of Synthesis
06.2010 - 10.2017

Job overview

  • Company Overview: (A wholly owned subsidiary of Cipla Ltd.)
  • Overseeing the synthesis, isolation of various drug molecules Impurities, Metabolites, deutero labeled drug molecule (Isotopomers). The route is scouted by retro synthesis, Literature support, sourcing of raw material and Intermediates.
  • Providing data necessary for Preparing DHR (Drug History Report), PDR (Process Development Report) for the molecules to be filed for USFDA / European FDA.
  • Sourcing & Identification of strategic business partners (Domestic and International).
  • Identified and generated new clients for Impurity supply from international and domestic market.
  • Interfacing between buyers and manufacturer for facilitating smooth order execution and handling the entire business cycle from quotation to closing the sale. Identifying client requirements & specifications, obtaining approval for samples and conduct price negotiations to firm up the orders.
  • Looking after financial viability of projects and preparing quotations.
  • Strategizing on international business development by planning & market assessment for sales target, profit margins, market share and service support.
  • Confidentiality Agreement, Master Service Agreement and Project Contract finalizing.
  • Gave presentation and seminars to the clients on business opportunities and company products.
  • Designing and supporting SEO, Brochures, Website, exhibition advertisements, etc.
  • Study scheduling, tracking entire projects.
  • Identified new business to increase the sales revenue.
  • Tracking and provided future market requirements to company to prepare well in advance for market needs.
  • Coordination with finance team for budgeting, cash flows etc.
  • Coordinating with the regulatory affairs team to handle queries related to identifying, isolating known/unknown impurities.
  • Highlights: Synthesized/isolated many drug impurities likes Salmeterol impurity H (EP), Donepezil open ring (USP), Bupropion Thiomorpholine (USP), Omeprazole E & F (EP) and deuterated labeled molecules such as Samaterol-d3, Fluticasone-d3, Celecoxib-d7, Deferociroc-d4, Nifedipine d6.

Neucon Pharma Pvt Ltd

General Manager
11.2009 - 06.2010

Job overview

  • Sourcing strategic business partners (domestic and International) for API Impurity standards, working standards, metabolites, custom synthesis molecule.
  • Team development & training: Employee development, guidance & performance management.
  • Involved in route scouting, process development, impurity synthesis / isolation in drug substance and its characterization. Synthesis on gram scale & maintain a high standard of documentation of work.
  • Responsible for activities associated with projects such as planning, coordination, analysis and co-ordination between related departments etc.
  • Highlights: Efficiently developed and marketed various API Impurity standards. Develop new business relationship with many pharmaceutical groups as customer.

Sequel Pharmachem Pvt Ltd

General Manager - Research and Development (API)
03.2007 - 02.2009

Job overview

  • Directing a team of scientists in development and technology transfer of new, cost effective manufacturing process routes for bulk API.
  • Developing processes for scaling up from lab to pilot plant and transferring technology to internal or external contract manufacturers, custom synthesis, identification and synthesis of known, unknown impurity id API.
  • Coordinating with the production and quality assurance team for smooth technology transfer.
  • Managing the commercial out-sourcing of chemicals, intermediates and API’s.
  • Selecting and developing vendors for assuring QA and RA compliance.

Unichem India Pvt Ltd

Research Scientist –API
01.2003 - 02.2007

Job overview

  • Preparation of the synthesis report of for process development wrt patent infringement, cost reduction and commercialization using an available chemistry database like STN, Sci-finder, Belstein etc.
  • Identifying & synthesizing the impurity of finished bulk drug molecule by synthesizing and purification column chromatography technique.
  • Coordinating with production and technology transfer team, in case of the production problems, Process improvement wrt yield, cost and operational convenience.
  • Preparing relevant documents as per the guideline ISO 9001and GMP for technology transfer.
  • Highlights: Proficiently developed non infringing patentable route for some API. Filled a patent for the new process for the molecule Lamotrigine (WO2007069265) and Losartan Potassium (WO2007119246). Developed transfers ANDA molecule on production scale and validate process as per US FDA requirement. (Lamotrigine)

Novartis Enterprises India Pvt Ltd

Research Scientist
10.2002 - 12.2002

Job overview

  • Optimizing the process of synthesis of bulk drug molecules on lab scale wrt quality & quantity.
  • Conducting the literature survey and optimizing the process for existing API molecule.
  • Identifying and preparing the impurity of the finished bulk drug molecule.
  • Highlights: Developed clopidogrel non infringing route in the lab and prepared a supportive document wrt. Technology transfer.

Cipla Pvt Ltd

Research Executive
10.1994 - 10.2002

Job overview

  • Development and optimization of the process for synthesis bulk drug molecule in lab.
  • Conducting the literature survey for molecule using chemical abstract on as well as an electronic database, like STN and Sci-finder.
  • Complete Technology transfer of API from Lab to the production Scale.
  • Highlights: Efficiently developed processes many API molecules (steroid/non-steroids molecules) in laboratory scale and transfer on production scale. (Celecoxib, Valdecoxibe, Fluticasone, Mometasone, Finasteride, Clopidogrel, Olanzapine etc) Gained knowledge about: Commercialization approach of API Processes from Lab to production scale Develop, Reference work: To find out & collect the literature of the R&D projects by accessing a database of Libraries of IIT-Mumbai, UICT Library-Mumbai and Sci-finder/STN.

Education

NMIMS Global Access School for Continuing Education

Post Graduate Diploma in Business Management
01.2017

University Overview

University of Mumbai

Ph.D. from Organic Chemistry
01.2016

University Overview

Thesis entitled "Synthesis of some novel aza heterocycles and study of their pharmacological activity" at the St. Xavier College, Mumbai under the guidance of Prof. (Dr.) Freddy H. Havaldar.

University of Mumbai (Institute of Science, Churchgate Mumbai)

Master of Science from Organic Chemistry
01.1994

University Overview

GPA: First class

R.N Ruia College, Mumbai University

Bachelor of Science from Chemistry
01.1992

University Overview

GPA: First class

Skills

Synthesis Organic Chemistry

Publications

Publications
  • “Novel process for Synthesis of enantiomerically pure piperazine derivative.” Indian patent application. 1742/MUM/2009 – Publication date 2009-12-11.
  • “A Novel process for Synthesis of Lamotrigine and its intermediate.” PCT patent application no.(WO/2007/069265), 2497/MUM/2008-A.
  • “Anhydrous process for preparation of Telmisartan.” PCT patent application no.2497/MUM/2008 A, Publication date 2008-12-19.
  • “An improved process for the manufacture of Losartan potassium.” PCT patent application no.WO/2007/119246.
  • “Novel Method for the Syntheses of 2-Substituted Benzimidazoles Using Ti(IV) Isopropoxide and Cumene Hydroperoxide” Synthetic Communications, Volume 41(15), 2011, 2304-2308.
  • “Microwave promoted Synthesis of some novel 4-(4-Methyl-phenyl) substituted phthalazin-1-one derivatives” Synthetic Communications. Volume 43(8), 2013, 1127-1137.
  • “Microwave Promoted One Pot synthesis Of Some Novel N-Aryl Iso-quinoline Derivatives." Journal of heterocyclic chemistry. Volume 50, 2013, Issue 4, pages 828–837.

Timeline

Technical Director
Novapure Healthcare Pvt Ltd
01.2018 - Current
Head of Project: API, Intermediates
Cogent Life Science Pvt Ltd
10.2017 - 01.2018
Head of Synthesis
Sitec Labs Pvt Ltd
06.2010 - 10.2017
General Manager
Neucon Pharma Pvt Ltd
11.2009 - 06.2010
General Manager - Research and Development (API)
Sequel Pharmachem Pvt Ltd
03.2007 - 02.2009
Research Scientist –API
Unichem India Pvt Ltd
01.2003 - 02.2007
Research Scientist
Novartis Enterprises India Pvt Ltd
10.2002 - 12.2002
Research Executive
Cipla Pvt Ltd
10.1994 - 10.2002
University of Mumbai
Ph.D. from Organic Chemistry
University of Mumbai (Institute of Science, Churchgate Mumbai)
Master of Science from Organic Chemistry
R.N Ruia College, Mumbai University
Bachelor of Science from Chemistry
NMIMS Global Access School for Continuing Education
Post Graduate Diploma in Business Management
Dr. Bhushan Vasant Dabholkar