Vishal Rathod
Boston,MA
Summary
Experienced scientist dedicated to excelling in the design and development of pharmaceutical products, emphasizing the enhancement of patient well-being. Expertise in pre-formulation studies, formulation technology, and process development leverages advanced methodologies to improve bioavailability for poorly soluble compounds across diverse dosage forms, including modified release, targeted delivery, and sterile preparations. Proven leadership skills include guiding teams, managing complex projects, and achieving strategic objectives through effective planning, mentorship, and cross-functional collaboration. Recognized for a collaborative approach and unwavering commitment to excellence, offering a fresh perspective and strong dedication to quality and success while aspiring to contribute as a scientific leader and subject matter expert in comprehensive development and manufacturing strategies.
Overview
15
15
years of professional experience
Work History
Scientist II Formulation Sciences
Blueprint Medicines, a Sanofi Company
01.2024 - Current
- Led > 3 projects as the workstream lead for the FIH development aclinical manufacturingnd
- Led formulation development at the discovery-development interface, guiding programs (small molecules and new modalities) from candidate selection to First-in-Human readiness as a formulation sciences workstream lead.
- Provided formulation support suitable for each phase and collaborated closely with teams in medicinal chemistry, biology, process chemistry, DMPK, toxicology, and preformulation for formulation-related activities.
- Planned and executed drug product development strategies, including formulation design, process characterization, and supporting clinical manufacturing, with a focus on data-driven decisions and risk mitigation.
- Managed external partnerships with CROs and CMOs during GLP and GMP stages to ensure successful manufacturing, quality compliance, and efficient technical transfers.
- Led activities at external manufacturing sites, supporting batch execution, troubleshooting, and documentation in partnership with Quality Operations.
- Contributed to multiple continuous improvement initiatives at Blueprint (AI initiative, Lab and infrastructure establishment, and pharmaceutical sciences engagement initiatives).
- Supported regulatory filings (IND and IMPD for Canada and EU) by drafting and reviewing drug product sections and working with regulatory teams and vendors to meet submission timelines.
- Promoted innovation and scientific knowledge-sharing by contributing to journal clubs, staying current with new technologies, and mentoring junior colleagues to build team capabilities.
Scientist I Formulation Sciences
Blueprint Medicines
10.2021 - 12.2023
- Developed phase-appropriate solid oral formulations for early-stage candidates, supporting both preclinical and clinical development with a focus on bioavailability, stability, and safety.
- Conducted formulation and drug product development activities for crystalline base, salts, and amorphous dispersions, from experimental design and process optimization to technology transfer and vendor oversight for GMP manufacturing.
- Characterized API and drug product properties and contributed to analytical method development and stability studies, ensuring formulation performance met quality and regulatory expectations.
- Assessed biopharmaceutical properties and product attributes of various drug substance forms.
- Led the relocation of the solid oral formulation lab, successfully transferring equipment, technology, and infrastructure to enhance workflows and capabilities with new containment systems.
Research Assistant
Natoli Institute of Industrial Pharmacy and Lachman Institute
09.2015 - 09.2021
- Prepared stable nanosuspensions using wet stirred media milling, anti-solvent precipitation, and homogenization approaches.
- Supported a NCE program for developing phase appropriate formulation approaches to enable long acting release profile: microspheres, implants, and controlled release oral tablets.
- Developed amorphous solid dispersions (ASDs) and dried nanosuspension using hot melt extrusion (HME) and spray drying (SD) techniques to enhance drug solubility/dissolution rate including the downstream processing of final powdered blends and tablets.
- Studied effects of type and concentrations of surfactant and lipids on stability of nano lipid drug carriers.
- Worked with Natoli Engineering on troubleshooting and enhancing manufacturing process as well as DP development.
- Worked with new chemical entities (NCEs) on several NDA projects to optimize dry and wet granulation process using roller compaction, high shear granulator, and fluidized bed granulator.
- Worked on multi-unit particulate systems (MUPS) using FBD. Investigated efficiency of enteric coating on tablets using dissolution.
- Investigated tablet processing problems such as sticking, picking, capping etc. for various internal and external collaborators using Piccola 8-station rotary tablet press and presster compaction simulator.
- Performed sample analysis/ material’s solid state and drug product characterization/ supported product development activities for pharmaceutical companies, contract research and manufacturing organizations (CRO’s & CMO’s).
- Supported in developing a novel liquid nebulizer solution and suspension for a small molecule based therapeutic company filing for 505(b)(2)NDA. Managed sourcing of APIs and raw materials, analytical method development, solubility and solid-state characterization, forced degradation, formulation development and characterization, and stability studies.
Formulation Development Intern
Merck Animal Health
06.2020 - 08.2020
- Developed high-throughput excipient compatibility test protocol for Chew Tablets and Tablets.
- Assisted in analyzing the data from design of experiments utilized to optimized wet granulation process.
- Researched, compiled, and presented a draft guidance document of fit-for-purpose prototype long acting injectable/parenteral formulations development protocol for pre-clinical development team.
Pharm Sci-Analytical Science Intern
Merck Research Laboratories
06.2018 - 08.2018
- Distinguished kinetic solubilities of a salt and free base form using a surface dissolution UV imaging system.
- Studied the relationship between intrinsic dissolution rate and salt disproportionation risk at all pH conditions
- Developed a novel method to characterize the drug release lag time from film-coated tablets using SDi2.
Research Intern (Co-op)
Amneal Pharmaceuticals LLC
09.2016 - 12.2016
- Developed a complete product profile by identifying (q1), quantifying (q2), and providing inputs in developing identical microstructure (q3) for different sterile drug products.
- Developed rheological methods for complex sterile ophthalmic products to formulate the identical microstructure to the reference listed drug. Performed viscosity and gel-sol based studies (shear rate, non-newtonian fluidics) on in situ ocular gelling product.
- De-formulated the sterile products by developing the formulation based calculative model interlinking osmolality, buffer capacity, pH, and elemental analysis.
- Assisted in sterile manufacturing of pilot scale micro-emulsion in a GMP approved facility.
Research Intern (Summer)
Amneal Pharmaceuticals LLC
06.2016 - 08.2016
- Provided inputs in developing portfolio for dosage form development and assisted in preformulation studies
- Formulated bench scale ocular products by high-pressure homogenization, IKA mixer, and ultrasonication.
- Reverse engineering for the batches prepared using the formulation and characterization techniques:
- Formulation: Sterile ophthalmic: micro-emulsions, ointments, creams, suspensions, gel-forming solutions.
- Characterization: hot stage microscope, Horiba–globule size distribution, rheometer, and osmometer.
Product Specialist
Ronsan Pharmaceuticals
03.2014 - 05.2015
- Performed pre-formulation and formulation studies for the product development of solid dosage forms
- Conducted compatibility studies of the active compounds and excipients and performed disintegration and dissolution testing on tablets. Drafted technical documents including laboratory notebooks, batch records.
Trainee
Aeterna Healthcare Pvt. Ltd
07.2012 - 12.2012
- Performed pre-formulation studies: particle size analysis and literature review.
Industrial Trainee
Emil Pharmaceuticals Ltd
05.2011 - 06.2011
- Analyzed samples obtained from primary production to demonstrate compliance with relevant specifications.
Education
PhD - Pharmaceutical Sciences
Long Island University
Brooklyn, NY, USA09.2021
MS - Pharmaceutics
Long Island University
Brooklyn, NY, USA01.2018
Bachelor of Pharmacy - undefined
Mumbai University
India05.2012
Skills
- Product Development Skills: Drug product development, Preformulation studies, process optimization, QbD and biopharmaceutics-based profiling, solubility enhancement: nanosization/ASDs/lipids/Films, DOE and modified release drug delivery systems
- Dosage forms: Solid and Liquid Oral (suspensions, solutions, capsules, tablets), Ophthalmic, and Injectable Products, as well as Semi-Solid and implantable Products
- Equipment Expertise: Spray drying, Hot melt extrusion, FBD, High Shear, Roller Compaction, Compaction Simulation, Tablet Press, coating, 3D printing, homogenization, and ultrasonication
- Characterization and Analytical Tools: mDSC, TGA, Moisture Sorption, PXRD, FTIR, Microscopy, Malvern 3000, Zetasizer (DLS), UV, HPLC, UPLC, Disintegration test, In-vitro drug release studies (dissolution and diffusion)
- Software Skills: Minitab 19, JMP, Design expert, Unscrambler (multivariate statistics), PDXL (XRD), TA Universal Analysis (mDSC)
Timeline
Scientist II Formulation Sciences
Blueprint Medicines, a Sanofi Company
01.2024 - Current
Scientist I Formulation Sciences
Blueprint Medicines
10.2021 - 12.2023
Formulation Development Intern
Merck Animal Health
06.2020 - 08.2020
Pharm Sci-Analytical Science Intern
Merck Research Laboratories
06.2018 - 08.2018
Research Intern (Co-op)
Amneal Pharmaceuticals LLC
09.2016 - 12.2016
Research Intern (Summer)
Amneal Pharmaceuticals LLC
06.2016 - 08.2016
Research Assistant
Natoli Institute of Industrial Pharmacy and Lachman Institute
09.2015 - 09.2021
Product Specialist
Ronsan Pharmaceuticals
03.2014 - 05.2015
Trainee
Aeterna Healthcare Pvt. Ltd
07.2012 - 12.2012
Industrial Trainee
Emil Pharmaceuticals Ltd
05.2011 - 06.2011
MS - Pharmaceutics
Long Island University
Bachelor of Pharmacy - undefined
Mumbai University
PhD - Pharmaceutical Sciences
Long Island University
Honors, Awards & Professional Activities
Track Chair: AAPS abstract screening committee, 2023 - Current
Best Abstract Award (AAPS): From Computational Predictability to Verification of Anti-Solvent Precipitation Process, Solid State Characterization, and In-Vitro Dissolution of a Weakly-Basic Nanoamorphous Micellar Dispersion, 2020
Seed Grant Award: 3D Printed Nanoparticles-Loaded-Orally Disintegrating Tablets for Pediatric Patients (LIU) 2019
Rho Chi Award: Beta Theta Chapter at LIU Pharmacy, Honor issuer: Rho Chi Society, 2018
Reviewer: Various pharmaceutical sciences journals and the AAPS abstract screening committee, 2017 - Current
Publications
- B Gajera, H Shah, B Parekh, V Rathod, M Tilala, R Dave: Design of experiments-driven optimization of spray drying for amorphous clotrimazole nanosuspension, AAPS PharmSciTech, 2024
- V Rathod, A Pinniti, B Gajera, R Dave: Strategizing spray drying process optimization for the manufacture of redispersible indomethacin nanoparticles using quality-by-design principles, AAPS PharmSciTech, 2024
- V Patel, V Rathod, R Haware, W Stagner: Optimized L-SNEDDS and Spray-Dried S-SNEDDS Using a Linked QbD-DM3 Rational Design for Model Compound Ketoprofen, International Journal of Pharmaceutics, 2022
- H Shah, V Rathod, P Basim, B Gajera, R Dave: Understanding the Impact of Multi-factorial Composition on Efficient Loading of the Stable Ketoprofen Nanoparticles on Orodispersible Films using Box-Behnken Design, Journal of Pharmaceutical Sciences, 2021
- V Rathod, WC Stagner, B Gajera, R Haware: Hybridized Nanoamorphous Micellar Dispersion Using a QbD–DM3 Linked Rational Product Design Strategy for Ritonavir: a BCS IV Drug, International journal of pharmaceutics, 2020
- V Rathod, D Shah, R Dave: Systematic implementation of quality-by-design (QbD) to develop NSAID-loaded nanostructured lipid carriers for ocular application: preformulation screening studies and statistical hybrid-design for optimization of variables, Drug development and industrial pharmacy, 2020
- WC Stagner, M Iyer, V Rathod, SK Meruva, S Staton, R Haware: Human Volunteer, In vitro, and Molecular Level Evaluation of an Optimized Taste-Masked Isoniazid-Chitosan Spray-Dried Microparticle Matrix, International journal of pharmaceutics, 2019
- V Rathod, C Kinkema, H Chen: Role of Citric Acid in Enhancing Drug Performance: A Double-Edged Sword?, AAPS – Orlando, Florida, 2023
- V Rathod, V Patel, R Haware: Investigating the Role of Critical Formulation and Process Variables Using Hybrid-design Approach on the Redispersibility of Spray Dried Coprecipitated Nanoamorphous Micellar, AAPS - Orlando, Florida, 2023
- X Yu, V Rathod, L Morin, B Pepper, S Lucas, H Chen: Control of Recrystallization in Tablets Containing Amorphous Solid Dispersion, AAPS - Boston, 2022
- V Patel, V Rathod, Nikita Patil, Robert Sedlock, R Haware: Effect of Relative Humidity on Physico-Mechanical Properties of Coprocessed Excipient MicroceLac 100, CombiLac, and StarLac by DM3 Approach, AAPS - Philadelphia, 2021
- V Patel, V Rathod, R Haware: Application of Computational Machine Learning Tools to Compare Predictive Performance on Critical Quality Attributes of Spray Dried Lipid-based Formulation, AAPS (Virtual), 2020
- V Rathod, B Gajera, WC Stagner, R Haware: From Computational Predictability to Verification of Anti-Solvent Precipitation Process, Solid State Characterization,and In-Vitro Dissolution of a Weakly-Basic Nanoamorphous Micellar Dispersion, AAPS (Virtual), 2020
- V Rathod, B Gajera, R Haware: Development of Nano-amorphous Spray Dried Powder to Improve Dissolution Rate: Stabilizer Selection and Formulation Optimization Using Quality by Design (QbD) Approach, AAPS – San Antonio, 2019
Thesis
- Author: V Rathod, Title: Solubility Enhancement and Taste Masking of Bitter and Poorly Soluble BCS Class IV Drug Using Hybridized Nanoamorphization and Micellization Methodology, Status: Unpublished for IP, Year: 2021
- Author: V Rathod, Title: Optimization and design of ibuprofen-loaded nanostructured lipid carriers using a hybrid-design approach for ocular drug delivery, Status: Master's Thesis published, LIU, NY - ProQuest, Year: 2018