Ashish Shah

Commercial manufacturing support:

• Technical lead for process and technology-related projects to support commercial manufacturing operations for a blockbuster drug ($1B in sales), ensuring product quality and a process yield exceeding 85%.
• Collaborated with managers, operators, and vendors to perform root cause analysis on failing systems to ensure an uninterrupted supply of products to patients (> 100 batches/year).
• Develop and implement process improvement strategies to optimize production efficiency. Designed and implemented process improvements and control strategies to improve product quality.

Project management:

• Worked alongside diverse teams to maintain adherence to 3-month-per-batch performance goals for drug product release.
• Managed relationships with internal stakeholders, vendors, suppliers (raw materials and equipment), and CMOs (external organizations).
• Lead risk management and change management activities: Perform risk assessments for process and equipment-related changes, and implement necessary changes.
• Prepared technical reports and presentations to communicate findings and recommendations to management. Technical owner of quality documentation, such as change management, deviations, and CAPAs.

Technical Operations/Manufacturing Support:

• Served as the technical lead for process-related changes, equipment qualifications and management, and technology-related projects, managing over 20 major process changes for commercial products.
• Coordinated maintenance and repair activities to minimize downtime and maintain production targets. Maintained records of all maintenance activities, service requests, and storage information for equipment (30+ production equipment).
• Designed and implemented process improvements and control strategies to improve product quality.
• Optimized production processes (increased efficiency and reduced manpower) through automation, saving over 8 hours of setup time per batch.
• Determined design criteria or specifications for process and equipment-related changes. Evaluate and recommend equipment upgrades to enhance productivity and reduce costs.

Project Management:

• Managed multiple large capital projects concurrently, from conception through the commissioning and validation stages (> $1 million/project). Created accurate project specifications and documented them in technical manuals.
• Managed relationships with vendors, suppliers (raw materials and equipment), and CMOs (external manufacturing)—coordinated activities with suppliers, contractors, and other departments to achieve department goals.

Technical Operations/Manufacturing Support:

• Supported both cleaning and process validation of pharmaceutical drug product manufacturing operations.
• Developed process documentation and training material to support the standardized processes and new product launches.
• Collaborated with other departments such as Quality Control and Maintenance on projects related to process engineering initiatives.
• Prepared technical reports and presentations to communicate findings and recommendations to management.

• Worked on the plant floor with the technicians, plant manager, supervisors, engineering staff, and other staff to troubleshoot technical problems in manufacturing and/or packaging equipment.
• Authored and reviewed production documentation, such as batch records, SOPs, and deviations. Trained production personnel on the use of production systems and procedures.
• Planned and developed manufacturing processes, based on process documentation and lab studies, to run safely and efficiently in the pilot plant, while ensuring cGMP compliance.
• Worked with purchasing and warehouse to ensure that raw materials and production supplies were available before manufacturing, as per schedule.
• Prepared instructions for unit operations, production batch records, bill of materials, and other GMP-related documentation for all processes run in Production.

• Performed research goals related to process development, technology development, and production of active pharmaceutical ingredients (API).
• Developed and optimized processes to improve productivity, product quality, and product consistency.
• Monitored key performance indicators (KPIs) to assess process performance and identify improvement opportunities.

• Performed research goals related to process development, technology development, and production of active pharmaceutical ingredients (API).
• Performed hands-on process development and scale-up work consisting of scales ranging from laboratory to commercial.
• Developed and optimized processes to improve productivity, product quality, and product consistency.