Vivek Gera

CEO

Jersey City, New Jersey, United States10 yrs 5 mos experience

Most Likely To SwitchAI Enabled

Key Highlights

Founder of an AI platform for pharmaceutical compliance.
Expert in GxP compliance and automation.
Led significant process engineering projects in mining.

Stackforce AI infers this person is a leader in Healthcare and Pharmaceutical compliance technology.

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Skills

Core Skills

Artificial Intelligence (ai)Regulatory ComplianceGxp ComplianceProcess ControlProcess Engineering

Other Skills

Acid Water TreatmentAutomationC#Cement SlurriesChange ManagementChemical EngineeringEnterprise Risk ManagementEnterprise SoftwareExperimental StudyFDA GMPMVC FrameworkManufacturingPharmaceutical ManufacturingProcess OptimizationProcess Simulation

About

Leucine is an AI-powered platform that helps pharmaceutical manufacturers stay compliant and audit-ready while ensuring their medicines reach patients faster. Using Leucine, the Manufacturing, QA, and QC teams can significantly increase productivity and reduce deviations from cGMP guidelines across thousands of complex regulated workflows from material receipt to batch release. See in action: https://www.leucine.io

Experience

Leucine

CEO

Nov 2019 – Present · 6 yrs 4 mos · New York, United States · On-site

Leucine is an AI-powered platform that helps pharmaceutical manufacturers stay compliant and audit-ready while ensuring their medicines reach patients faster.
Using Leucine, the Manufacturing, QA, and QC teams can significantly increase productivity and reduce deviations from cGMP guidelines across thousands of complex regulated workflows from material receipt to batch release. Leucine supports manufacturers across all modalities, such as small molecules, biologics, gene therapies, vaccines, etc.
For more information, visit: https://www.leucine.io

Artificial Intelligence (AI)Regulatory ComplianceFDA GMPPharmaceutical ManufacturingEnterprise Risk ManagementEnterprise Software+4

Independent

GxP Compliance Consultant

Aug 2017 – Nov 2018 · 1 yr 3 mos · San Francisco Bay Area

Specialist in the domains of GxP Compliance and Automation in Regulated Manufacturing. Provided technical consulting in the area of GxP Compliance to Fortune 500 Pharma / Medical Devices Companies.

Regulatory ComplianceAutomationGxP Compliance

Rio tinto

2 roles

Process Control Engineer

Feb 2014 – Mar 2015 · 1 yr 1 mo

Conceptualised, developed (using MVC framework in C#) and implemented an action driven process control monitoring system from scratch for 14 Pilbara Iron Ore mine sites.

Process ControlC#MVC Framework

Process Engineer

Sep 2012 – Jan 2014 · 1 yr 4 mos

Led recommissioning project of the Acid Water Treatment Plant and brought it to a treatment capacity of 5ML/day. Devised and implemented a Self-optimising pH control strategy (non linear) from the first principles leading to (a) Downtime < 5% (b) Raw material consumption < 1.10 times steady state consumption (c) Zero process related incidents.

Process EngineeringpH Control StrategyAcid Water Treatment

Norwegian university of science and technology (ntnu)

Erasmus Mundus Fellow - European Union

Jul 2010 – Dec 2010 · 5 mos · Trondheim Area, Norway

The only undergraduate from India to be awarded the prestigious "Erasmus Mundus Fellowship" by the European Commission (Fall 2010).
Worked with Prof. Sigurd Skogestad, who is one of the pioneers in researching self-optimizing control schemes, in association with SINTEFF, the largest independent research organization in Scandinavia. Published research work in ScienceDirect (by Elsevier).

Schlumberger

Process Engineer - Well Cementing Services

May 2010 – Jul 2010 · 2 mos · Mahape base, Mumbai

Designed and accomplished an experimental study, conclusively comparing cement slurries for fluid-loss properties leading to enhanced economic outcomes for a major client of the company.

Experimental StudyCement SlurriesProcess Engineering