Profile Details

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Hire Dr. Bharat K.

United States

USD 90 /hr

Formulation Development, Validation, and Tech Transfer Professional. 15-years combined industrial & academic experience.

Profile Summary

Quality by design: Build quality into drug product from early development Extended release: Formulation of tablets, capsules, and suspensions for extended release Process Validation: Translate developed formulation to commercial readiness CDMO Management: Leadership of validation and manufacturing in external CDMO Fundamentals: Strong physicochemical foundation for DP formulation & characterization NDA Module 3: Support, author, and review filing documents as SME Servant Leadership: Influence without Authority and Leading without Consensus

Subject Matter Expertise

• ☆ Materials Science & Engineering
• ☆ Deformulation
• ☆ Nanotechnology
• ☆ Industrial Engineering
• ☆ Manufacturing
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Small Molecule Manufacturing
• ☆ Pharmaceutical Technology
• ☆ Inventory Control
• ☆ Product Validation
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Technical & Scientific Writing
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Formulation
• ☆ Pharmaceutical Formulation
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing, Copywriting, Newswriting

Research Market Research, User Research, Feasibility Study, Fact Checking, Gap Analysis, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Validation, Manufacturing, Prototyping

Work Experience

Scientist

Novel Laboratories (Now Lupin Pharmaceuticals)

December 2014 - Present

CMC Project Manager (contract)

Sanofi

March 2023 - March 2025

Associate Director Formulation Development

MapLight Therapeutics

June 2022 - August 2022

Senior Manager, Formulation Development

Spero Therapeutics

August 2020 - May 2022

Senior Scientist, Product Development

Lupin Pharmaceuticals

April 2019 - June 2020

Scientist, Product Development

Lupin Pharmaceuticals

December 2014 - March 2019

Scientist, Product Development and Technical Services

Ohm Laboratories

June 2013 - November 2014

Education

Pharmaceutical Sciences, Industrial Pharmacy

St. John's University

September 2007 - May 2014

Ph.D. Industrial Pharmacy (Pharmaceutical Sciences)

St. John's University College of Pharmacy & Health Sciences

August 2007 - April 2014

Pharmacy

Institute of Chemical Technology - Mumbai, India

October 2003 - April 2007

Certifications

• Financial Management Specification

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://credentials.giesbusiness.illinois.edu/3c097e4d-b708-4676-b990-0c4a753a8a2b

  August 2025 - Present

• How to Stop Being Busy and Start Being Strategic

  LinkedIn

  https://www.linkedin.com/learning/certificates/0b3b663841f5a546015e90146ac0d9825d18a71d09cfe42be433f6e022167452?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;5ShhcEy9Rc+BgheM617kDQ==

  July 2025 - Present

• Operations Management: Quality and Supply Chain

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://www.coursera.org/account/accomplishments/records/HZPE11VUAVTH

  July 2025 - Present

• Corporate Finance II: Financing Investments and Managing Risk

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://www.coursera.org/account/accomplishments/records/Z2ZP27JYOH9L

  July 2025 - Present

• Managerial Economics & Business Analysis Specialization

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://credentials.giesbusiness.illinois.edu/bbb74731-0079-4234-a60c-18ba5447fd98

  June 2025 - Present

• Operations Management: Organization and Analysis

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://www.coursera.org/account/accomplishments/certificate/2FOAPPNQ2D8I

  June 2025 - Present

• Strategic Leadership & Management Specialization

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://credentials.giesbusiness.illinois.edu/bd19d4c9-3ddb-4721-9ba8-4edbedd1ca4b

  June 2025 - Present

• Corporate Finance I: Measuring and Promoting Value Creation

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://www.coursera.org/account/accomplishments/records/40LMGRSXUHHM

  June 2025 - Present

• Entrepreneurship and Strategic Innovation Specialization

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://credentials.giesbusiness.illinois.edu/04ce48a8-e663-43af-9049-e4f5d8b68a08

  January 2025 - Present

• Managerial Economics and Business Analysis Specialization

  Gies College of Business, University of Illinois at Urbana Champaign (Coursera)

  https://www.coursera.org/account/accomplishments/specialization/ZYIXQGIFRWWT

  January 2025 - Present

• Registered Scrum Master

  Agile Education by Scrum Inc.

  http://s3.amazonaws.com/scruminc-certs/RSM-1323236

  January 2025 - December 2025

Publications

PATENT

Bharat Kirthivasan (2019). Stable liquid compositions of sodium picosulfate . US20190224177A1.

Bharat Kirthivasan (2019). Extended release suspensions of mixtures of dextro-and levo-amphetamines .

BOOK CHAPTER

Bharat Kirthivasan(2019). Nanostructures in pharma: elixir to oral medicine . Nanoparticles in Pharmacotherapy. p. 23--44. Elsevier

Bharat Kirthivasan, Bharat Kirthivasan (2015). Influence of Supercritical Carbon Dioxide for Pharmaceutical Processing: From Infancy to Present . Advances in Material Science Research Vol 18.

JOURNAL ARTICLE

Bharat Kirthivasan (2017). Adsorption onto Mesoporous Silica Using Supercritical Fluid Technology Improves Dissolution Rate of Carbamazepine-a Poorly Soluble Compound . AAPS PharmSciTech.

Bharat Kirthivasan (2013). In vivo brain microdialysis as a formulation-screening tool for a poorly soluble centrally acting drug . Drug development and industrial pharmacy.

Bharat Kirthivasan (2012). In vivo brain microdialysis to evaluate FITC-dextran encapsulated immunopegylated nanoparticles . Drug Delivery.

Bharat Kirthivasan(2012). Active brain targeting of a fluorescent P-gp substrate using polymeric magnetic nanocarrier system . Nanotechnology. 23. (25). p. 255102. {IOP} Publishing

Bharat Kirthivasan(2010). The formulation, characterization and in vivo evaluation of a magnetic carrier for brain delivery of NIR dye . Nanotechnology. 21. (39). p. 395102. {IOP} Publishing