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Snehal Khedkar

Lecturer @ School of Pharmacy & Technology Management, NMIMS, Mumbai

Principal Scientist / Drug Product Development

Greater Boston Area

Ranked #953 out of 19,060 for Lecturer in United States

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Snehal Khedkar's Email Addresses & Phone Numbers

Snehal Khedkar's Work Experience

School of Pharmacy & Technology Management, NMIMS, Mumbai

Lecturer

July 2006 to October 2006

Frequency Therapeutics

Principal Scientist/Drug Product Development

May 2016 to November 2019

Boston, MA

FORUM Pharmaceuticals

Senior Development Scientist, Formulation Development

September 2015 to January 2016

Waltham, Massachusetts

Snehal Khedkar's Education

Institute of Chemical Technology (UDCT), University of Mumbai

Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences

2002 to 2006

Institute of Chemical Technology (UDCT), University of Mumbai

M.S., Pharmaceutical sciences, A

1999 to 2001

Bombay College of Pharmacy, University of Mumbai

Bachelor of Pharmacy (B.Pharm.)

1996 to 2000

Snehal Khedkar's Professional Skills Radar Chart

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Questioning
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Snehal Khedkar's Estimated Salary Range

About Snehal Khedkar's Current Company

School of Pharmacy & Technology Management, NMIMS, Mumbai

Frequently Asked Questions about Snehal Khedkar

What company does Snehal Khedkar work for?

Snehal Khedkar works for School of Pharmacy & Technology Management, NMIMS, Mumbai


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Snehal Khedkar is Lecturer


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What industry does Snehal Khedkar work in?

Snehal Khedkar works in the Biotechnology industry.


Who are Snehal Khedkar's colleagues?

Snehal Khedkar's colleagues are Gideon Shapiro, Scott Nolan, Carolyn Gentile, Sharif Uddin, Gerhard Koenig, Raksha Acharya, Liza Leventhal, and Maria Ph.D.


About Snehal Khedkar

📖 Summary

Lecturer @ School of Pharmacy & Technology Management, NMIMS, Mumbai From July 2006 to October 2006 (4 months) Principal Scientist/Drug Product Development @ Frequency Therapeutics • Spearhead drug product development and related CMC activities for ongoing programs and provide suitable formulations for preclinical, toxicity study and clinical studies, while working cross-functionally.• Work collaboratively with biology team and experts in field to evaluate required target product profile and then strategize formulation/drug delivery/acceptance criteria accordingly.• Work collaboratively with analytical and drug discovery team to assess ‘developability’ of molecules, characterize drug substance and evaluate performance of developed formulations (stability, release)• Identify/invent novel drug delivery systems solving complex drug delivery problems and leading to the creation of proprietary products o Major accomplishments: Idealized, designed and developed a robust delivery system enabling first clinical drug product for intratympanic delivery, resulting in IP (US patent application filed)• Design and conduct (hands-on) pre-formulation, formulation development and physical testing of a developed formulation suitable for preclinical study.• Identify, vet and select drug product manufacturers suitable for Phase I and II studies and execute project objectives through these contractors. • Lead formulation project management to support ongoing animal studies at CROs for various developed formulations using a cross-functional team approach.• Author and review CMC sections for IND submissions, pilot/clinical batch records, and technical reports. • Make team presentations to cross-functional teams providing inputs and strategies helping decision making.• Hire, mentor and supervise co-op students every six months bi-annually. From May 2016 to November 2019 (3 years 7 months) Boston, MASenior Development Scientist, Formulation Development @ FORUM Pharmaceuticals • Formulation Leader for Phase II Compound FRM-0334.• Led and completed formulation development of oral capsule/tablet formulations that met the target product profile to enable Phase II a/IIb studies. • Managed project activities and timelines. Liaised with CMO regarding project activities and deliverables.• Wrote, reviewed, and edited GMP and non-GMP formulation development documentation to support clinical trials.• Participated in cross-functional teams. From September 2015 to January 2016 (5 months) Waltham, MassachusettsResearch Scientist II , Formulation & Analytical @ TetraPhase Pharmaceuticals • Idealized, designed, conducted pre-formulation and formulation development of for various molecules in pipeline.• Performed hands on analysis of drug substance/drug product, as well as developed dissolution methods.• Developed stable oral capsule, tablet, suspension and parenteral dosage forms to meet the target product profile for TP434, TP271, TP834 for preclinical and/or Phase I studies.• Liaised with CMOs and facilitated formulation technology transfer. • Major accomplishments: o Developed pre-formulation technical package for lead compound TP434 (Eravacycline).o Supported development of I.V. dosage form of Eravacycline using lyophilization technology and conducted various drug product compatibility and stability studies (now known as Xerava).o Developed stable oral tablets for Eravacycline that was suitably scaled up to support Phase I study.• Verified CRO developed analytical methods for drug substances (HPLC, LCMS) and performed daily analysis, thus supporting process chemistry.• Conducted impurity profiling, solid, and solution stability studies for multiple lead molecules in pipeline.• Authored pharmaceutical development technical reports, protocols, and related CTD portions for regulatory submissions- IND filing, reviewed draft and executed clinical manufacturing batch records.• Supervised and mentored two scientists (with MS degrees) and five to six co-ops every year with daily activities. From May 2009 to December 2012 (3 years 8 months) Watertown, MAResearch Executive (R&D) Formulations @ Ipca Laboratories Limited • Developed formulation and process for ANDA (US/EU market) – SR Metformin; SR Diclofenac tablets, SR pellets in capsule (extrusion-spheronization) for Venlafaxine (EU).• Evaluated patents and proposed strategy.• Supported process scale up and technology transfer to CMO.• Liaised with analytical teams and regulatory affairs to ensure project deliverables. • Mentored and guided scientists working toward their master degree qualifications. From October 2007 to August 2008 (11 months) Formulation Scientist @ Halo Pharmaceutical, Inc. • Led formulation/process development, as well as clinical trial material manufacturing of small molecules.• Developed a very difficult fluid bed coating process (1 kg to 40kg) for enteric-coated pellets of an enzyme product used in prevention of antibiotic associated diarrhea and led its CTM manufacturing for Phase II clinical studies.• Improved an existing multi-step manufacturing processes for a commercial drug product (encapsulated mini tablet formulation) to reduce yield losses from 30% to 5%, (Scaled up from 25 kg to 300 kg).• Successfully led multi-step scale up and manufacturing of registration batches for three DEA-controlled drug substances that went into ANDA filing. • Developed composition and a robust roller compaction process for drug substance with poor flow properties yielding drug product that met target product profile.• Conducted transfer of manufacturing processes to the validation group. • Worked on aggressive timelines to support regulatory filing deadlines for multiple client projects.• Authored and reviewed batch records, protocols, and reports. From May 2013 to August 2015 (2 years 4 months) Whippany , NJ


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Snehal Khedkar's Personality Type

Introversion (I), Intuition (N), Feeling (F), Judging (J)

Average Tenure

1 year(s), 10 month(s)

Snehal Khedkar's Willingness to Change Jobs

Unlikely

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