Chintan Dalwadi

M. Pharm, Ph.D. (Pharmaceutics)

Talent

greater london, england, United KingdomMember since September 30, 2026

Formulation developmentTechnology transferSterile formulationsANDA projectsRegulatory submissionsEudraLexBatch manufacturing recordProcess validationDesign of Experiment (DoE)MINITABDOE++Project managementOOS/OOT investigationRoot cause analysisChange controlDrug excipient compatibility studyAPI characterizationStability studiesClinical supply manufacturingRisk assessments

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Formulation developmentTechnology transferSterile formulationsANDA projectsRegulatory submissions

About

Dedicated, Ph.D., having experience of more than 12 years in Formulation and Development and Technology transfer of Liquid orals and Sterile formulations for Europe and UK (MHRA) market

Experience

Development and Technology Transfer Leader - Crescent Manufacturing Limited - Park Royal, UK

(2026-01)

Accountable from an MSAT perspective for defining technology strategy & specific solutions as required to support the overall commercialization of product or dose form lifecycle.
Responsible for coordinating the review of regulatory submissions and responses to technical questions within MSAT and management of response to regulatory queries from MHRA regarding formulation development and technology transfer relevant to R&D.
Formulation development of Liquid orals ANDA projects and branded generic projects including solutions, suspension and oral concentrates and Technology transfer to production team.
Maintaining accountability for the product, from transfer from R&D throughout its lifecycle manufacturing
Develop relationship with different departments like Regulatory affairs, Production – UK, purchase, ADL, Production – UK and QA for proceeding in formulation development.
Mange meetings and providing projects updates on formulation developments, technology transfer and stability reports, analytical development and regulatory filing
Drive the project management process for new and existing projects during initiation, planning, execution, monitoring and control of the project.
To plan and perform scale-up and technology transfer activities. Review and Approval of technology transfer documents i.e, batch manufacturing record, process validation and hold time protocol, process validation and hold time reports, Elemental Impurity Report, Nitrosamine Report
Reviewing departmental quality documents i.e., bioavailability report, elemental impurity report, nitrosamine report, pharmaceutical equivalency report, product development report and relevant documents to support regulatory department.
Responsible for coordinating with contract development/manufacturing labs and maintaining overall accountability of the outsourced projects
Understanding of regulatory guidelines; ICH (Quality Guidelines), EMEA, EudraLex

Investigator Leader – Sterile Drug Product Development - GSK - Ware, UK

(2024-10 - 2025-10)

Develop robust Drug Product formulations & processes to meet development in accordance with regulatory guidance.
In partnership with internal and external partners, contribute to drug product development and manufacturing efforts
Build strong relationships with key internal and external stakeholders to help facilitate the delivery of DP objectives. Participate in a highly cross-functional internal and external CMC team environment.
Preparing oral or written summaries of results with interpretation for project work. Presenting effectively to internal GSK forums and external meetings.
Support clinical supply manufacturing, batch record development, change control implementation, formal risk assessments and technical investigations. Provide virtual and/or on-site support for process development/scale-up/transfer activities at internal and external sites.
Design and deliver experimental strategy/plans using QbD principles, perform data trending and analysis and interpret results, prepare/review development reports and contribute to preparing regulatory documents.
Support knowledge management strategies and execution needed for regulatory filings and a commercially viable drug product.

Formulation Team Leader - F&D & Technology Transfer - B&S Group, Syri Limited - UK

(2022-08 - 2024-10)

Formulation development of Liquid orals, Solid oral and Sterile ANDA projects and Branded Generic projects including solutions, suspension, solution for injections, oral concentrates and tablets etc.
Develop strong, collaborative relationship with different departments like purchase, ADL, F&D- India, Production – UK, RA- India & UK and QA for proceeding in formulation development.
Providing projects updates on formulation developments and stability reports
Drive the project management process for new and existing projects during initiation, planning, execution, monitoring and control of the project.
To resolve problem, review and optimization of process parameters to minimize risk during technology transfer.
To plan and perform scale-up and technology transfer activities. Preparation & review of technology transfer documents i.e, batch manufacturing record, process validation and hold time protocol, process validation and hold time reports
To perform Exhibit and Validation batches for new and existing projects also with coordination with CMOs
Preparation of response to regulatory agency queries – relevant to R&D.
Preparing or contributes to departmental quality documents i.e., elemental impurity report, pharmaceutical equivalency report, product development report and relevant documents to support regulatory department.
Works with contract development/manufacturing labs and maintains overall accountability of the outsourced projects
Handling of OOS/OOT investigation, root cause analysis, change control and deviation through QMS
Understanding of regulatory guidelines; ICH (Quality Guidelines), EMEA, EudraLex
Highlights own training needs and working with manager develop a training plan and achieve training goals
Maintain department facilities (safety and quality), records, equipment and procedure in line with GMP

Sr. Research Scientist – F&D & Technology Transfer - B&S Group, Syri Limited - UK

(2019-06 - 2022-07)

Formulation development of Liquid orals, Solid oral and Sterile ANDA projects and Branded Generic projects including solutions, suspension, solution for injections, oral concentrates and tablets etc.
Preparing pre-formulation solubility study, designs experiments and preparation of prototype formulations as per Quality by Design approach and carries out scientific work with development and characterizing formulation and stability studies
Literature search, Formulation strategy planning, Raw materials procurement, Patent evaluation
Innovator product characterization, drug excipient compatibility study and reverse engineering studies and conducting API characterization
To plan and perform scale-up and technology transfer activities - initiation, planning and execution.
Preparation & review of technology transfer documents i.e, batch manufacturing record, process validation and hold time protocol, process validation and hold time reports
To perform Exhibit and Validation batches for new and existing projects also with coordination with CMOs
Preparation of response to regulatory agency queries – relevant to F&D.
To resolve problem, review and optimization of process parameters to minimize risk during technology transfer.
Preparing or contributes to departmental quality documents i.e., elemental impurity report, pharmaceutical equivalency report, product development report and relevant documents to support regulatory department.
Handling of OOS/OOT investigation, root cause analysis, change control and deviation through QMS
Understanding of regulatory guidelines; ICH (Quality Guidelines), EMEA, Eudralex
Contribution and training of Pharmaceutical Software: Design of Experiment (DoE), MINITAB, DOE++

Sr. Research Scientist – F&D - B&S Group, GRPL - India

(2015-12 - 2019-05)

Formulation development of Liquid orals, Solid and Injectables ANDA projects (Suspension, Powder for oral suspension, Solution) and Branded Generic projects
Literature search, Formulation strategy planning, Raw materials procurement, Patent evaluation, pre-formulations as per QbD approach using Design of Experiment (DOE)
Innovator product characterization, drug excipient compatibility study and reverse engineering studies and conducting API characterization
To take laboratory trials, stability batches and other product related studies and documentation of same
Prepare and review stability compilation sheets, internal laboratory SOPs, maintenance of equipment and appropriately records details on raw materials.
Documentation as per regulatory requirements such as Draft Specifications, Qualitative and Quantitative composition regulatory form, Impurity Profile, Product Development Report, etc.