HIREN SONI, P.Eng.

*** ****** ***, *********, ** N3T 0B7 (: 519-***-****

*: acrmws@r.postjobfree.com

HIGHLIGHTS OF QUALIFICATIONS

Over 20 years professional engineering experience in every aspects of Pharmaceutical and Chemical Industry with excellent project, process and people management skills. Proven track of record in directing process, project operations and staff in fast paced result oriented environment. Managed commissioning, qualification, process start up teams in a multi production API project (50KL to 175KL volume).

Managed process operation and successfully handle and commercialize several Active pharmaceuticals ingredients.

Diverse and successful research and development background with experimental design, Technology transfer and process scale up

Solid understanding of process chemistry and implementation, cGMP compliance in a manufacturing environment and analytical chemistry in product quality assessment

Excellent experience in project execution including plant design, preparation of Front- end study report, process flow diagram, P&ID, specifications, equipment layout and IQ, OQ and PQ

Well organized and able to maintain professional standards in a fast paced environment

Excellent communication skills, attention to detail and accuracy

Enjoy working in a team to share new ideas and produce optimal results

Completely familiar with cGMP, CAPA, GLP, SOP, ICH and FDA guidelines

Specialties

Extensive operational expertise in establishing and maintaining cGMP or equivalent processes

Pharmaceutical (API) Facility Design

Technology Transfer

Project management

Process development, Optimization and validation

Process scale up and trouble shooting

Qualification activities (IQ, OQ - Commissioning), Process and Cleaning Validation

PROFESSIONAL EXPERIENCE

APOTEX PHARMACHEM INC. CANADA 2004- present

group leader

The areas of responsibilities include process characterization and implementation, process costing, root cause analysis and CAPA, Process technology optimizations and scale up.

Mentor and train junior staff on new technology and day to day work within the department..

Applying engineering knowledge and expertise to scale up and implement processes from lab scale to plant production.

Writing and executing Installation, Operational, Performance and Process Qualifications

Providing batch process optimization and schedule scenarios for the new processes developed

Providing PFDs, P&IDs, mass balances, raw material specifications, and bill of materials

Writing of MBRs, SOPs, DMF, APRs, CCs and experimental design protocols under cGMP.

Providing cost and benefit analysis for the economic evaluation of the projects

Coordinate with Operations management, Production staff, and Quality Control on scheduling priorities.

Conduct on-the-floor monitoring of production in progress and offer guidance to production staff in process execution. Conduct in-process testing as required.

Troubleshoot problems encountered during new process piloting or routine production, and design and carry out experiments, with R&D as necessary, to investigate and resolve production problems.

Complete campaign summaries and evaluate campaign success with respect to campaign goals. Complete up-to-date costing analyses of assigned processes and critically evaluate production costs; identify methods for cost reduction.

Identify opportunities for improvements in process chemistry, plant unit operations, cGMP compliance, and production scheduling.

Recommend, design, acquire, organize installation of, commission, and ensure qualification of low capital cost enhancement projects.

CADILA PHARMACEUTICALS LIMITED. INDIA 2001 - 2003

Executive - Pilot plant

Responsible for the kilo lab and pilot plant activities including process scale up, technical package preparation, Technology transfer to different site and contract manufacturing activities.

Successfully scaled up different Active Pharmaceutical Ingredients (API’s) from lab to kilo lab and to the commercial plant level with process validation

Responsible for production planning and optimum plant utilization, utility calculation, energy consumption and costing

Performed Raw Material Costing (RMC) and Gross Contribution (GC) calculation for all API’s and intermediates to understand the market potential

Prepared SOP’s and Master Batch Records based on test and validation batches

Responsible for the preparation of technical package including batch manufacturing process, standard test procedure, in-house specification and product development record (PDR)

Implemented general safety standards WHMIS, MSDS, HAZOP

Assist in process technology transfer activities to contract manufacturing sites for assigned processes.

DISHMAN PHARMACEUTICALS AND CHEMICALS LTD. INDIA 1999 - 2001

Senior Project Engineer

Successfully designed, erected and commissioned a 175 KL capacity plant for the Active pharmaceuticals Ingredients within twenty percent less time for the joint venture of SOLVAY Pharmaceuticals Inc, Netherlands and Dishman Pharmaceuticals Ltd

Responsible for preparing accurate Front-end study reports, P&ID, process flow diagram, equipment and plant layout, detailed specification of processing equipment and drawing

Write validation protocols for the processes, equipments and facilities with critical parameters as per guidelines

Mentor junior project engineer staff on new and ongoing projects and guide their work on assigned projects.

Equipments and facilities qualifications (IQ, OQ, PQ)

Identified new equipments as per process requirements from a validation perspective and qualified vendors

Prepared protocols and qualified HVAC systems for the different finish product handling areas

Economic evaluation of project and prepared detailed budget for the ongoing and new projects with the time frame

Efficiently planned and executed multi purpose plant facilities as per cGMP norms including installation, commissioning and validation of equipment within the specified time frame and project budget

TORRENT PHARMACEUTICALS LIMITED. INDIA 1995 - 1999

Production Supervisor

Responsible for meeting deadlines in the production and efficient utilization of manpower

Achieved quality of the final products according to the pharmacopoeia, safety, cGMP standards and communication with service department like utility and quality control

Developed and directed the implementation of production scheduling and reporting procedures

Prepared yearly expense and capital budgets

Responsible for corporate safety and environmental compliance including Hazardous Operation (HAZOP) study and Hazardous Material analysis

Expertise in unit operations like Distillation, Hydrogenation, Bromination, Nitration, Condensation, Chloro sulphonation and Grignard reaction

EDUCATION

Bachelor Of Chemical Engineering

Gujarat University, Gujarat

PROFESSIONAL DEVELOPMENT

Licensed Professional Engineer of Ontario

Training on USFDA guidelines by Dr. Daniel Harpez, Harpez Consultancy Services-USA

"GMP - The ICH guide for API manufacturers" Training conducted by Dr. Norman C. Franklin, Managing Director of Interactive Consulting Associates Ltd., Europe

REFERENCES AVAILABLE ON REQUEST

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