JG

JAY GANDHI

Senior Manager, Product Development at Capstone Development Services

Jay Gandhi has a diverse work experience in the pharmaceutical industry. JAY began their career as an Intern in Manufacturing Operations at MACLEODS PHARMACEUTICALS LTD. In this role, they followed SOPs and safety guidelines for tablet manufacturing processes and performed in-process testing for tablet dosage forms.

Jay then worked as a Chemistry Laboratory Technician and later as a Graduate Student Researcher at Long Island University, CW Post Campus. In these roles, they performed various research experiments, conducted literature reviews, and authored abstracts, presentations, and manuscripts. JAY also prepared materials for chemistry laboratory classes and ensured that all required materials and equipment were stocked and available.

After completing their education, Jay joined Zoetis as a Quality Control Chemist. JAY conducted chemical and physical analyses on raw materials and final products, ensuring compliance with company SOPs and regulations. JAY also investigated deviations and wrote exception reports.

Jay then joined Baxter International Inc. as a Research Associate. JAY successfully completed new product development and transfer projects, partnering with manufacturing sites to identify and solve problems. JAY also utilized Six Sigma processes to lead product and process improvement initiatives. During their time at Baxter, Jay received a Rising Star Award nomination.

Next, Jay worked at Pfizer as a Scientist, where they led and supported formulation and process development activities for complex sterile injectable products, including combination products. JAY was the single point of accountability for these projects.

Currently, Jay is employed at Capstone Development Services Co, LLC. JAY started as a Product Development Manager and is currently serving as a Senior Manager, Product Development - Formulation. In these roles, they lead and manages multiple drug product development and manufacturing projects, including drug-device combination products. JAY is responsible for identifying and evaluating external service providers, driving product development and scale-up activities, and ensuring successful registration and commercial launch.

Overall, Jay Gandhi has demonstrated expertise in product development, process optimization, and quality control within the pharmaceutical industry.

Jay Gandhi has a solid education background in the field of biomedical sciences and pharmacy. JAY obtained their Bachelor's degree in Pharmacy from Savitribai Phule Pune University, completing their studies in 2010. Subsequently, they pursued a Master's degree in Biomedical Sciences, General from LIU Post, which they completed in 2013. In 2016, Jay enhanced their knowledge by obtaining a Diploma in Quality Management from Advance Learning Interactive Systems Online (ALISON).

In addition to their formal education, Jay Gandhi has also pursued various certifications to further broaden their skill set. JAY completed a two-day course on The Pharma Business Development with Stefan Fischer, offered by CELforPharma, in June 2022. In 2016, they obtained a Lean Six Sigma Green Belt Training certification from Baxter International Inc. JAY also acquired knowledge in Six Sigma - Understanding Design of Experiment (DOE) in July 2016, and applied Six Sigma techniques to the process validation lifecycle through a certification from PDA - Parenteral Drug Association in March 2015.

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Previous companies

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Timeline

  • Senior Manager, Product Development

    April 1, 2023 - present

  • Product Development Manager

    November, 2019