Keyur Bhalodia

Dynamic and results-driven technical leader with 17+ years of experience in GMP pharmaceutical, biopharmaceutical, and food manufacturing. Specializes in process performance, technology transfer, scale-up, validation, change control, and deviation/CAPA management. Proven track record delivering high-value, complex projects in API and bioconjugate manufacturing — including molecules and processes successfully registered and approved through FDA Drug Master Filing (DMF).

Adept at leading cross-functional teams, driving continuous improvement, and ensuring regulatory compliance to enhance operational efficiency and product quality.

Production Supervisor at Aspire Bakeries (2024-12 – 2026-06)

• Lead daily production operations with full ownership of process performance, downtime tracking, waste categorization, and data reporting to support continuous improvement initiatives.
• Maintain zero-incident safety performance; conduct root cause analysis (RCA) for safety events and ensure compliance through Intelex reporting.
• Successfully supported BRC and FDA audits, ensuring strict adherence to GMPs and internal quality standards.
• Served as SME for SAP PCE/S4 HANA implementation, improving real-time data flow from warehouse to production; trained 29 ingredient mixers, achieving full successful implementation.
• Performed RCA and authored nonconformance reports; adjusted process specifications based on run data and SAP MII data to drive corrective actions.
• Collaborated cross-functionally with Quality, Maintenance, Sanitation, and Utilities teams to ensure all products met specifications and customer requirements.
• Applied structured CI tools including 5 Whys, Gemba walks, Centerlining (CIL), Hyper Care, and run-data audits to drive operational improvements.

Production Supervisor at ARA Avanti RX Analytical Inc. (Medical Unit of Tilray) (2024-02 – 2024-11)

• Oversaw formulation, fill/finish, decarboxylation, grinding, and curing operations of controlled substances in a Class 7 cleanroom GMP environment, ensuring full compliance with SOPs and safety regulations.
• Launched 15 new products by generating and executing change controls aligned with VMP plan requirements, successfully introducing products to international markets.
• Developed and revised SOPs, Master Batch Records (MBRs), and controlled documents, improving operational consistency and regulatory compliance.
• Served as Acting QPIC, ensuring adherence to controlled-substance regulations.
• Led hiring, training, scheduling, and performance management to meet production targets and maintain a compliant, high-performing workforce.
• Performed IQ/OQ/PQ validation of production equipment, authoring technical protocols and final reports as SME.

Team Leader at Eurofins CDMO (2016-06 – 2022-04)

• Managed cross-functional project teams across Pilot Plant, Kilo Labs, and HPAPI Kilo Lab, providing coaching and guidance to ensure successful process execution.
• Served as SME for small- to large-scale kilo lab process setup, including manufacturing, evaluation, and validation of new equipment per qualification protocols.
• Authored and reviewed multi-scale batch records for buffer preparation in PDE/GMP environments; drafted, revised, and approved SOPs in accordance with change control procedures.
• Led engineering and execution team for new HPAPI Kilo Lab design, equipment qualification, and site setup; maintained effective management communications while ensuring quality, efficiency, and productivity.
• Drove end-to-end project delivery across Process Improvement, Cycle Time Reduction, Cost Reduction, API manufacturing qualification, and Technology Transfer initiatives, consistently meeting deadlines.
• Applied hands-on expertise in small- to large-scale chromatography and Tangential Flow Filtration (TFF) for biological molecules.

Production Supervisor / QA Supervisor at Joriki Inc. (2010-02 – 2016-06)

• Supervised batching, pasteurization, and aseptic filling operations in an ISO 9001/22000 beverage facility, ensuring full compliance with HACCP and GMP requirements.
• Managed a team of 28 operators, maintaining safety, quality, and compliance with regulatory and internal standards.
• Optimized utilization of pasteurizers, fillers, and packaging equipment; performed CIP & SIP per GMP standards to maximize line efficiency.
• Designed a changeover matrix and led downtime investigations, reducing customer complaints by more than 50% and improving line efficiency by 25%.
• Conducted RCA on production issues and developed and implemented corrective and preventive action (CAPA) plans to drive sustained process improvements.
• Reviewed and approved line clearances, ATP swabs, and batch records to ensure consistent product quality.

Pilot Plant Associate at Radiant Technologies Inc. (2009-06 – 2009-12)

• Performed cell extraction, filtration, distillation, liquid-liquid extraction, and preparative HPLC to isolate high-value alkaloids from biomass crude, achieving 99% purity.
• Operated large-scale 9-foot column chromatography; evaluated fractions by TLC and concentrated conforming fractions using a 20 L Buchi rotary evaporator.

Research Assistant at Brock University (2007-05 – 2008-05)

• Conducted independent literature reviews and performed computational quantum analysis of organic reactions using physical chemistry software to determine reaction pathways and transition states.

Bachelor of Science in Biotechnology – Brock University (2008)

Diploma in International Business Management – Royal Canadian Institute of International Studies (2004)

Bachelor of Engineering in Chemical Engineering – M. S. Ramaiah Institute of Technology (1999)