Vishal Sharma

Lead the entire product and process development plan from raw material sourcing, formulation, testing, packaging compatibility, process innovation and scale-up to achieve launch milestone. Ensure products and packaging are safe, effective and comply with regulatory requirements. Responsible for all regulatory compliance-related technical operations and technology transfer.

Planning and executing the overall process flow of several projects at various stages of development, optimization, exhibition, and launch. Facilitating a seamless handoff between R&D and production through the coordination of technological processes. Overall responsibility for project initiation, validation and life cycle management including problem-solving.

Daily planning and distribution of tasks for the region. Compliance monitoring for all work allocations. Projects report (OEE- Overall equipment efficiency and output improvements) update and task completion reporting.

LEAD PROJECT MANAGEMENT | TECHNICAL OPERATIONS - Orbicular Pharmaceutical Technologies Pvt Ltd, India - India

(2019-08)

• Responsible for all technical operations and technology transfer in relation to regulatory compliance.
• Dossier compilation from all the CMO's and review the sections for its submission purpose.
• Lab setup with Anticancer formulation development facility and maintaining its operations.
• Responsible for product development strategy till the submission batches on site and post regulatory submission with its committed timelines.
• All CMO execution and Operations management and compliance per the regulatory requirements.
• Single point of contact and responsible for all CMO during all regulatory audits along with quality team.
• Responsible for all observations and responses with respect to audit and compliance timelines based on the current regulatory requirements.
• Prepare all phases of R&D process and plan summary for development, scale-up, registration and launch operations.
• Overall process flow planning and implementation for various projects in development, optimization, exhibition, and launch.
• Effective costing and budgeting for small and large-scale projects, as well as their operational execution.
• Project Coordination with a cross-functional team and external customer is essential for immediate and effective compliance with project and operational tasks.
• Project costing and mapping with its strategy and demand for the custom and regulatory requirement.

SR. MANAGER - Fresenius-Kabi Oncology Ltd, India - India

(2018-05 - 2019-06)

• Technology transfer and Project Management.
• Technology Coordinator within plant and R&D for smooth project transfer.
• Continues improvement in process and troubleshooting smooth operational executions.

MANAGER, TECHNICAL OPERATION - Sentiss Pharma Pvt. Ltd, India - India

(2016-08 - 2018-05)

• Responsible for global technology transfer for ophthalmic and injections, including planning and executing process flows for various optimization, process development, exhibit batch execution, and improvement and troubleshooting for commercial operation.

DEPUTY MANAGER, TECHNOLOGY TRANSFER - Gland Pharma Ltd., India - India

(2012-05 - 2016-08)

• Technology transfer expert for injections, Ophthalmic, Lyophilized and prefilled syringes for regulatory projects.
• Coordination with all cross-functional teams to ensure a smooth technology transfer from R&D to commercial execution while adhering to quality and schedules.
• Responsible for all anticancer product development and the site operation and regulatory audit responsibility.

Jr. Manager, Process Development - Dr. Reddy's laboratories Ltd, India - India

(2007-07 - 2012-05)

Sr. Officer, Production & Validation - Dabur Pharma Ltd, India - India

(2005-06 - 2007-07)

Officer, Projects and Qualifications - Sun Pharma Ltd, India - India

(2004-08 - 2005-06)

Project Trainee - Nicholas piramal India Ltd, India - India

(2003-08 - 2004-08)

PH.D - Parul University, Vadodara, India

MASTER'S - PHARMACEUTICAL SCIENCES - Jawaharlal Nehru Technological University, India (2015)

BACHOLAR - PHARMACEUTICALS - Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, India (2003)