Rajneesh Luthra; P.Eng.

** ********** ******

416-***-**** (cell)

Email: abhqd9@r.postjobfree.com Toronto ON L6P 3K3

905-***-**** (resi.)

Objective: To obtain a progressing challenging position in a progressive

organization

EDUCATION:

. Professional Engineer of Ontario (PEO)

Nov. 06

. Applied for PMP certification

Nov. 14

. Project Management courses from Humber College Toronto : -

Dec. 12 - Aug 13

Project Management Skill Development (CNST 704), Project Resource

Planning and Scheduling (CNST 709)

Project Cost Management (CNST 718)

. Pharmaceutical courses from Seneca College Toronto : -

Jan. 05- Dec. 10

Advanced Regulatory Affairs / Advanced Formulation Methods /

Validation and Qualification of Pharmaceutical Products / Industrial

Drug Legislation / Pharmaceutical Manufacturing Methods

. Honors Bachelor of Science in Chemical Engineering (B.E.)

July 89-June 93

Department of Chemical Engineering, Punjab University, Chandigarh,

India (Credentials evaluated by University of Toronto)

Highlight of Experience:

. Experience in Process Design calculations, Process Flow Diagrams, R&D,

Formulation Development, Scale up, Optimization, New Product Launch,

Validation and Commercial Product manufacturing

. Possesses excellent problem solving, creative, communication skills:

written and verbal

. Excellent computer skills in MS-office, VISIO, LIMS, Trackwise,

Docubridge and SAP activities

. Good interpersonal, organizational, presentation, leadership, multi-

tasking and documentation skills

. Excellent attention to detail, independent judgment and effective team

player

. Good theoretical knowledge of liquid and semi-solid formulation

development

. Experience to work as Lead Investigator for non-conformance issues and

develop appropriate corrective and preventive actions (CAPA)

. Experience with continuous improvement methodologies such as Lean

Manufacturing and Six Sigma

Skills:

. Pharmaceutical Skills: Dispensing, Blending, Compaction, Tableting,

Encapsulation, Film and Enteric Coating, High Sheer Wet Granulation,

Flaking, Extrusion and Fluid Bed Pellet Coating in solid dose

Other Skills: Solid GMP knowledge, Prospective, Concurrent, Cleaning

Validation, Equipment Qualification (Installation, Operation, Process,

Design Qualification), Regulatory submission (Common Technical Document,

CTD), Product Troubleshooting, Change Control Process, Product

Investigation and CAPA

Professional Experience:

Project Leader - Production

June12 to Present

Apotex Inc. (Weston / Etobicoke) Toronto ON www.apotex.com

. Identify and implement process improvement opportunities to enhance

production efficiency and capacity

. Review Technical Reports (Validation, Technical Operations, Formulation

Development, and Annual Product Review) and revised Manufacturing

Production Documents and approve in the Trackwise system.

. Develop efficient, cost-effective commercially viable manufacturing

processes for Solid Dose products

. Process troubleshooting and root cause analysis to meet performance and

increase productivity

. Lead and mentor the production technicians and provide technical

expertise to stakeholders

. Work with internal customers to identify and define projects that will

improve operations and reduce costs

. Work closely with Lean team for implementation of revised Change Control

Process to reduce change cycle time

. Lead as a Change Owner to implement production related changes and get

feedback, assessment from other business areas for successful change

. Provide technical and general support and guidance to Change Control

team's Technical Writers to ensure accuracy and completeness of MPD

updates.

. Provide Technical Production Impact assessment for all Request For Change

(RFCs)

. Act as a Lead Investigator for major and critical and recurring non-

conformance issues. Collaborate with Quality, Subject Matter Expert and

other related departments and develop appropriate CAPAs.

. Prepare Standard Operating Procedures for new activities and train

production personnel

Technologist - Product Launch (Technical Operations)

Sept.03 to May 12

Apotex Inc. (Weston / Etobicoke) Toronto ON www.apotex.com

Product Launch Activities:

. Evaluated early formulation trials, compatibility, stability and

optimization for critical process parameters to attain quality attribute

for Blend Uniformity, Content Uniformity, Assay and Dissolution profile

. Participated in activities leading to Technical Transfer, process

validation and commercial production troubleshooting under the guidance

of Scientist/Manager

. Developed formulae and process for new products which includes literature

searching, performing risk assessment for formulation/process

development, conducting experimental design and executing of lab scale

and pilot scale developmental batches to support the final formulation

and process

. Performed process optimization trials based upon the risk assessment

results within SUPAC levels

. Applied Six Sigma Technique of DMAIC e.g. Design of Experiment (DOE) to

resolve formulation issues

. Executed scale up verification/demonstration batch before validation

batches in commercial facility

. Write Technical Transfer Report to provide recommendations for validation

batches

. Supported Validation batches execution and reviewed the validation

reports

Existing Product Activities:

. Issued or reviewed Quality-Notifications to identify the root cause

problem for product investigation

. Investigated process design, formulation and process deficiencies to

recommend long term solutions

. Conducted small scale trials to find corrective actions and implement

solution to prevent future occurrence

. Lead multiple troubleshooting activities for commercial products on

manufacturing floor

. Evaluated data using statistical tools e.g. Cpk (process capability

analysis) to resolve production problems

. Executed trials to evaluate product performance for changes in raw

material supplier or alternate supplier

. Prepared reports and provided data to Regulatory department for

submission

Projects Handled:

1. Replaced time consuming equipment with equivalent high speed equipment

to increase productivity.

2. Scaled up production batch size from 90 kg to 540 kg in coating pan (48

inch to 66 inch), thus reducing manpower, overhead cost, documentation,

testing cost and other interrelated departments work.

3. Increased tablet press speed from 20 rpm to 60 rpm by change in

formulation within SUPAC level 1.

4. Handled enteric coated Delayed Release and matrix formed Controlled

Release products

Project Engineer

Oct. 01 to July 03

Justin Pharma and Engineering Inc. Chandigarh, India

A leading Consultant Company for bulk chemical, petrochemical, oil & gas,

pharmaceutical and gelatin plant

. Prepared basic and detailed engineering and technical specifications

for chemical industries

. Prepared Process Flow Diagrams (PFDs), Process and Instrumentation

Diagrams (P&IDs)

Process Engineer

June 93 to Oct. 01

Rallis India Limited Bombay, India www.rallis.co.in

A leading global organization having 5000 employees at 5 locations around

India in various chemical manufacturing and base for Boeing Aircraft USA

and India

. Handled independently the complete production unit operations involving

Chemical Reactions

. Provided technical leadership in the manufacturing of pesticide, API,

Polymers and specialty chemicals

. Introduced various systems to reduce production expenditure, energy

consumption that resulted in cost reduction in terms of line balancing,

debottlenecking, and design modification

Projects Handled:

Erection & Commissioning of Polymer manufacturing plant from initiation to

smooth production run

REFERENCES AVAILABLE UPON REQUEST

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