BHARGAV VYAS
Old Bridge
Summary
Regulatory CMC scientist with over a year of post approval life cycle management experience and Formulation Scientist with 5 years of sterile formulation development and internal/external technology transfer and regulatory affairs experience I hold over 6 years of pharmaceutical education with a master’s in industrial pharmacy. With proficiency in scientific formulation studies, ability to review and author CMC documents, and in-depth knowledge about cGMP, FDA, and ICH guidelines.
A proficient regulatory CMC scientist adept at implementing global product and project regulatory strategies through the authoring and review of CMC submission documents. Executes comprehensive assessments of CMC changes, identifies regulatory requirements, and critically evaluates supporting documents. Outcome-focused regulatory affairs professional conducting CMC activities across diverse global development stages, encompassing post-approval supplements, annual reports, registration renewals, market expansion, IND/IMPD, and responses to health authority inquiries. Ensures adherence to established business processes and systems for effective regulatory management. Frequently praised as adaptable and quick learner by my peers and have worked with a cross-functional teams of multiple companies. Worked on multiple Formulation Development projects of Injectables, sterile products, oral liquids, and topical products. Authored and Reviewed CMC documents required for regulatory filings. Serve as bridge between R&D facility and regulatory teams and handle multiple projects concurrently and on time. Substantial experience of coordinating with internal and CMOs production teams for a smooth operational and technology transfer of sterile and other products. In-depth knowledge of research and development of drug formulations, dosage forms and delivery systems.
Scientist skilled in leading research projects and driving innovative solutions. Deep expertise in experimental design, data analysis, and scientific writing. Strong focus on collaborative efforts and achieving measurable results. Known for adaptability, critical thinking, and reliability in dynamic environments. Proficient with molecular biology techniques, statistical software, and project management tools.
Overview
7
7
years of professional experience
Work History
Sr Scientist-Regulatory Affairs-CMC
Organon Inc.
10.2022 - Current
- Author, compile, and review CMC documents for pharmaceutical development projects, ensuring accuracy and compliance with regulatory standards
- Skillfully respond to agency inquiries, maintaining a track record of delivering high-quality submission documents that meet regulatory expectations
- Apply extensive knowledge of CMC regulations, ICH guidelines, and FDA requirements to guarantee global regulatory compliance
- Proficiently work with the eCTD format for streamlined electronic regulatory submissions
- Ensure strict adherence to cGMP to maintain product quality and meet regulatory standards
- Spearhead Global Regulatory Affairs initiatives, with a primary focus on Pre-Approval and Post-Approval activities for all regulatory CMC submissions
- Leverage in-depth understanding of pharmaceutical development and Preclinical development to drive successful regulatory outcomes
Formulation Scientist-II
Akorn Inc.
09.2021 - 09.2022
- Perform literature search and review, patent search and interpretation, perform risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes
- Author and review technical documentation related to CTD Module-2 and Module-3 like, Drug substance specifications, Release and stability Drug product specifications, manufacturing process flows, scale up manufacturing process documentation, technology transfer and process validation documentation
- Develop process for Injectable manufacturing employing a variety of pharmaceutical manufacturing techniques, including filter compatibility, Vmax study, solubility enhancement, etc
- Prepare and review BMR/MMR; Product Development Report (PDR), Process Characterization/Validation Protocol and Reports, Quality Overall Summary (QOS) and other necessary documents to support ANDA filing
- Perform Gap analysis and prepare responses to information requests and deficiency letters from FDA to support submissions
- Successfully executed and supervised Pivotal, Engineering and exhibit batches with reference to the QbD and guidelines provided by the FDA
- Actively participated and resolved Formulation development related issues from CRLs and DRLs from FDA
- Interact with eCTD submission team to manage submission of CMC documents and other material to the FDA
- Work as a liaison between R&D, Quality, regulatory affairs and manufacturing departments to fulfill 21 CFR part 4 requirements
Scientist
API Pharma Tech LLC.
04.2018 - 08.2021
- Executed Pre-formulation studies for injectable formulation like Solubility study, Order of addition, Excipient selection, IIG Evaluation
- Planned, conducted, and interpreted formulation and process development experiments as per self-written protocols for injectable formulations like, Sterilization optimization study, Material compatibility study, Container- closure suitability study and Freeze-Thaw study
- Interpretation of Literature search and patent search for a generic formulation
- Participated in technology transfer, prepared Technology Development report, QbD trial report, Risk Assessment, Identified CPPs, CQAs and QTPPs
- Developed product specifications for in-process, release, and stability, work closely with Analytical Research to reverse formulate generic products, Maintain a high level of quality and regulatory compliance
- Performed tests and release raw materials, finished products, in process samples, scale-up samples, process validation samples, cleaning validation samples and stability samples using a variety of standard analytical techniques
Education
M.S. - Industrial Pharmacy
St. John’s University
12.2017
B.S. - Pharmacy
K. B. Institute of Pharmaceutical Education & Research
06.2015
Skills
- Sterile Formulation development
- Scale-up
- Technology transfer
- Stability study
- QbD
- CPP
- QTPP
- Risk Assessment
- Pre- Formulation studies
- Formulation studies
- Product development trials
- Material compatibility
- Filtration studies
- Protocol and Report
- QOS
- Product Development report
- SOP
- Specifications
- IQ
- OQ
- PQ Preparation
- BMR & other Module 2 & 3 documents
- Troubleshooting
- Strong Communication
- Leadership
- Teamwork
- Pressure Management
- Multiple Project Work management
- Homogenizer
- Viscometer
- Density meter
- Autoclave
- Spray Dryer
- Freeze - Dryer
- Manual Tablet Compressor
- Capsule Filler
- Liquid Filling Machine
- Pumps
- Dissolution Apparatus
- Disintegration Apparatus
- HPLC
- GC
- Ion - Chromatography
- UV - Vis Spectrophotometer
- IR Spectrophotometer
- VTD
- Analytical Method development
- Method validation
- Quality control analysis
Documentation Skills
- Protocol and Report
- QOS
- Product Development report
- SOP
- Specifications
- IQ
- OQ and PQ Preparation
- BMR & other Module 2 & 3 documents
Equipment
- Homogenizer
- Viscometer
- Density meter
- Autoclave
- Spray Dryer
- Freeze - Dryer
- Manual Tablet Compressor
- Capsule Filler
- Liquid Filling Machine
- Pumps
- Dissolution Apparatus
- Disintegration Apparatus
- HPLC
- GC
- Ion - Chromatography
- UV - Vis Spectrophotometer
- IR Spectrophotometer
- VTD
Analytical Skills
- Analytical Method development and Method validation with HPLC
- GC
- Ion - Chromatography
- Quality control analysis
Formulation Skills
- Sterile Formulation development
- Scale-up
- Technology transfer
- Stability study
- QbD
- CPP
- QTPP
- Risk Assessment
- Pre- Formulation studies
- Formulation studies
- Product development trials
- Material compatibility
- Filtration studies
Timeline
Sr Scientist-Regulatory Affairs-CMC
Organon Inc.
10.2022 - Current
Formulation Scientist-II
Akorn Inc.
09.2021 - 09.2022
Scientist
API Pharma Tech LLC.
04.2018 - 08.2021
B.S. - Pharmacy
K. B. Institute of Pharmaceutical Education & Research
M.S. - Industrial Pharmacy
St. John’s University
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