Falgun Patel
Senior Scientist at Blueprint Medicines- Claim this Profile
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English Full professional proficiency
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Gujarati Native or bilingual proficiency
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Hindi Native or bilingual proficiency
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Bio
Pete Mustonen
I had the pleasure of working directly with Falgun for almost three years in Alkermes Analytical Development. He is a well-rounded analytical scientist, with a particularly strong HPLC, GC, dissolution, and particle size analysis background. He was a key contributor on several initiatives, including both early stage and late stage projects and non-GMP and GMP activities. He was a electronic systems team power-user and instrumental in introducing automated forms for electronic laboratory notebooks. Recently he was the lead analytical chemist supporting API manufacture and responsible for method development of both HPLC and particle size methods. He is a detail-oriented, diligent scientist and a great team member and colleague.
Shalin P.
It was pleasure to study with Falgun during my time at KLE college of Phramacy. It is not everyday that you come across someone as dedicated and motivated as Falgun. He is honest, dependable, and incredibly consistent for his study. I highly recommend Falgun as an asset to any team.
Pete Mustonen
I had the pleasure of working directly with Falgun for almost three years in Alkermes Analytical Development. He is a well-rounded analytical scientist, with a particularly strong HPLC, GC, dissolution, and particle size analysis background. He was a key contributor on several initiatives, including both early stage and late stage projects and non-GMP and GMP activities. He was a electronic systems team power-user and instrumental in introducing automated forms for electronic laboratory notebooks. Recently he was the lead analytical chemist supporting API manufacture and responsible for method development of both HPLC and particle size methods. He is a detail-oriented, diligent scientist and a great team member and colleague.
Shalin P.
It was pleasure to study with Falgun during my time at KLE college of Phramacy. It is not everyday that you come across someone as dedicated and motivated as Falgun. He is honest, dependable, and incredibly consistent for his study. I highly recommend Falgun as an asset to any team.
Pete Mustonen
I had the pleasure of working directly with Falgun for almost three years in Alkermes Analytical Development. He is a well-rounded analytical scientist, with a particularly strong HPLC, GC, dissolution, and particle size analysis background. He was a key contributor on several initiatives, including both early stage and late stage projects and non-GMP and GMP activities. He was a electronic systems team power-user and instrumental in introducing automated forms for electronic laboratory notebooks. Recently he was the lead analytical chemist supporting API manufacture and responsible for method development of both HPLC and particle size methods. He is a detail-oriented, diligent scientist and a great team member and colleague.
Shalin P.
It was pleasure to study with Falgun during my time at KLE college of Phramacy. It is not everyday that you come across someone as dedicated and motivated as Falgun. He is honest, dependable, and incredibly consistent for his study. I highly recommend Falgun as an asset to any team.
Pete Mustonen
I had the pleasure of working directly with Falgun for almost three years in Alkermes Analytical Development. He is a well-rounded analytical scientist, with a particularly strong HPLC, GC, dissolution, and particle size analysis background. He was a key contributor on several initiatives, including both early stage and late stage projects and non-GMP and GMP activities. He was a electronic systems team power-user and instrumental in introducing automated forms for electronic laboratory notebooks. Recently he was the lead analytical chemist supporting API manufacture and responsible for method development of both HPLC and particle size methods. He is a detail-oriented, diligent scientist and a great team member and colleague.
Shalin P.
It was pleasure to study with Falgun during my time at KLE college of Phramacy. It is not everyday that you come across someone as dedicated and motivated as Falgun. He is honest, dependable, and incredibly consistent for his study. I highly recommend Falgun as an asset to any team.
Experience
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Blueprint Medicines
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United States
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Biotechnology Research
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400 - 500 Employee
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Senior Scientist
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Dec 2021 - Present
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Lyndra Therapeutics
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United States
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Biotechnology
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1 - 100 Employee
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Scientist 2
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Aug 2020 - Dec 2021
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Scientist
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Dec 2019 - Aug 2020
Analytical scientist working on novel therapeutic drug delivery platform.
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Alkermes
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Ireland
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Biotechnology Research
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700 & Above Employee
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Senior Research Associate 2
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Jan 2017 - Nov 2019
• Technical writing for protocol, report to assist with NDA submission. • Key member of ‘Centers of Excellence’ team for Particle size, Authored guidance documents for method development, general use and maintenance of PSD instruments. • Introduced innovative techniques in drug substance and drug product analysis. • Developed, validated, and transferred various methods using GC, UPLC, Surface area, PSD etc. • Power-user of Electronic Lab Notebook and SDMS, represented department and… Show more • Technical writing for protocol, report to assist with NDA submission. • Key member of ‘Centers of Excellence’ team for Particle size, Authored guidance documents for method development, general use and maintenance of PSD instruments. • Introduced innovative techniques in drug substance and drug product analysis. • Developed, validated, and transferred various methods using GC, UPLC, Surface area, PSD etc. • Power-user of Electronic Lab Notebook and SDMS, represented department and guided IT on form development, bug identification, form qualification among other things. • Contributed in project team cross-functional project team meetings, CMC meetings etc. • Trained other team members on various techniques. • Team player responsible for achieving various project needs in timely manner. Show less • Technical writing for protocol, report to assist with NDA submission. • Key member of ‘Centers of Excellence’ team for Particle size, Authored guidance documents for method development, general use and maintenance of PSD instruments. • Introduced innovative techniques in drug substance and drug product analysis. • Developed, validated, and transferred various methods using GC, UPLC, Surface area, PSD etc. • Power-user of Electronic Lab Notebook and SDMS, represented department and… Show more • Technical writing for protocol, report to assist with NDA submission. • Key member of ‘Centers of Excellence’ team for Particle size, Authored guidance documents for method development, general use and maintenance of PSD instruments. • Introduced innovative techniques in drug substance and drug product analysis. • Developed, validated, and transferred various methods using GC, UPLC, Surface area, PSD etc. • Power-user of Electronic Lab Notebook and SDMS, represented department and guided IT on form development, bug identification, form qualification among other things. • Contributed in project team cross-functional project team meetings, CMC meetings etc. • Trained other team members on various techniques. • Team player responsible for achieving various project needs in timely manner. Show less
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SEQENS Pharmaceutical Solutions
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France
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Method Developement Scientist
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Jul 2012 - Jan 2017
• Independently developed robust and effective analytical methods for assay, impurities, residual solvents for raw materials, in-process control, final product release and stability testing of API, Intermediate, and other products in full compliance with cGMP and ICH guidances. • Phase appropriately validated/verified compendial/non-compendial methods based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration. • Authored and… Show more • Independently developed robust and effective analytical methods for assay, impurities, residual solvents for raw materials, in-process control, final product release and stability testing of API, Intermediate, and other products in full compliance with cGMP and ICH guidances. • Phase appropriately validated/verified compendial/non-compendial methods based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration. • Authored and executed validation protocols and reports based on scientifically sound acceptance critieria established for clinical phase of API. • Performed method transfer of analytical methods (from USP/EP/internal and external sources) to Quality Control department to ensure successful analysis of products during manufacture. Provided effective training for QC analysts on new methods and technology. • Collaborated with cross functional teams to establish appropriate specifications for in-process and final release testing. • Coordinated effectively with clients for development, manufacture, and release of product for new drug evaluations (NDEs) by supporting analytical aspects of project to meet project timelines. • Closely interacted with Process Chemists, Regulatory Affairs, Quality Assurance, and project teams to meet analytical development needs. • Authored Standard Operating Procedures (SOPs) to improve laboratory practices in accordance with changing regulatory environment. • Served as analytical subject-matter expert to help deliver and interpret analytical results related to manufacturing and development variations, Laboratory Investigations (LIR/OOS), Quality Investigations (QI). • Contributed to regulatory filings through submission of thorough scientific reports related to executed analytical protocols. • Identified gaps in existing analytical technology and data processing methods and devise approaches to improve them.
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Quality Control Analyst
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Jan 2012 - Jul 2012
• Provided accurate and timely results for the samples submitted for analysis to support manufacturing and research and development departments. • Used liquid chromatography, gas chromatography, ultra violet spectroscopy, infrared spectroscopy, titrimetry, particle size analyzer, TOC, and other techniques to assess the quality of Raw material, In-process, Final and Stability samples. • Performed calibration of the instruments used for analysis to industry standards. • Authored… Show more • Provided accurate and timely results for the samples submitted for analysis to support manufacturing and research and development departments. • Used liquid chromatography, gas chromatography, ultra violet spectroscopy, infrared spectroscopy, titrimetry, particle size analyzer, TOC, and other techniques to assess the quality of Raw material, In-process, Final and Stability samples. • Performed calibration of the instruments used for analysis to industry standards. • Authored operating procedures for the laboratory. • Maintained reference standard program. • Performed secondary data review for analyses conducted by other analysts. • Provided analytical expertise involving method re-validations, method re-development, and critical reagent qualification. • Conducted product degradation studies and qualify in-house reference standards and reference markers suitable for use in API testing. • Provided leadership (technical and procedural) and training for new colleagues to become effective analytical chemists. • Helped in method transfer, method validation and method verification of various compendial and non-compendial HPLC and GC methods.
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Acron Pharma PVT LTD
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Ahmedabad
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Junior chemist
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Feb 2008 - Jul 2008
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Esma formulations PVT LTD
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Ahmedabad, India
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QC intern
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Nov 2007 - Feb 2008
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Education
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2017 - 2017
University of Mississippi
Post graduate program, Pharmaceutical Sciences -
2008 - 2010
Long Island University
MS, Pharmaceutics -
2003 - 2007
Rajiv Gandhi University of Health Sciences
B.Pharm, Pharmacy
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