Proven leader with **+ years in healthcare, biotechnology and drug development.
Experienced in building and leading strategic, technological and operational changes.
International Regulatory/Quality experience
Demonstrated expertise in delivering results with both strategically and operationally focused teams.
Top performer with a track record of delivering measurable enterprise value to the bottom line through identifying opportunities, analyzing benefits, and executing action plans.
Effective in creating a positive and accountable culture focused on balancing results with associate growth and development..
Skills Summary
Team Building and Leadership
Process Improvement
Operational Planning
Excellent background in method development, training, validations of equipments and analytical methods,LIMS implementatin and IND filling.
Execellent Customer Service
Organizational Development
Experienced in developing and implementing regional and global quality programs for GMP and GLP laboratories
Drug Development
Skilled in FDA, EMEA, Canada, Japan and other International Regulatory agencies inspections and expectations
Reference Lab Operations
Strong Ananlytical Skills
Strong understanding of Statistical analysis and metrics-driven improvment
Professional Experience
REGENERON PHARMACEUTICALS
Director of Supply Chain Synchronization, May 2014-current
Work closely with all groups at Manufacuring Site to ensure business needs are met
Forecast driven planning of resources, equipment and infrastructure
Metrics to measure materials and information flow in order to determine performance gaps
Process improvement to achieve targeted business goals
Develop and deliver forecast and resource planning tools to all departments in IOPS
Design, standardize and implement performance metrics
Implement management review and corrective actions processes
Support departments to identify/improve/modify processes to meet targeted goals
Align IOPS departments operations management goals with supply chain planning parameters
Re-design Supply Chain organization to meet the increasing complexity of multiple products at different stage of drug development
Develop a forecast model for strategic growth planning and implementation
Lead External Manufacturing (fill and finish) and Supply Chain Compliance Team
DIRECTOR OF QUALITY CONTROL, January 2012-May 2014
Oversee work planning and technical guidance to lab personnel
Oversee data analysis and review and release of product
Oversee assay transfer internally from R&D to the QC laboratory or from Process Sciences to the QC laboratory
Act as QC liaison to External Manufacturing regarding transfer of identification assay to fillers and the performance of bioburden and sterility testing at the fillers
Oversee technical and regulatory reports, SOPs, Transmittals, CAPAs and CCs for area. Responsible for investigations for OOS deviation
Oversee quality system for monitoring OOS results, atypical results and invalid tests release intermediate and final product
Provide information to investigators as needed during regulatory audits
Ensure quality and regulatory compliance
Prepare annual employee evaluations and recommendations
Lead Operational Excellence and put processes for smooth operations in all labs across QC (Chem, Biochem and Micro), 80% backlog reduction in 6 months.
QUINTILES,INC.
EXECUTIVE DIRECTOR, GLOBAL QUALITY ASSURANCE& DATA MANAGEMENT SEPT. 2007 – NOV 2011
Developed Metrics for QLAB-performance and quality metrics
Lead several process improvement projects like Complexity metrics (Quality before launching a protocol), Demographics Quality process for QECG using Six Sigma Tools
Developed Culture of Quality Program for QLAB and QECG teams
Initiated and lead ISO 15189 cetification program for QLAB
Lead development of tools like Root Cause Analysis, Impact Analysis process for investigating quality incident and compliant
Lead the development of Quality Assurance strategy map
Lead a global team, participated and lead inspections world-wide.
Participation in selection and implementation of LIMS system-modular approach.
Implemented Effectiveness Check process in CAPA for continuous improvement.
Lead re-engineering Trackwise (QA database) through Quality By Design process
Managed the team of 55 employees worldwide with best in class ‘management effectiveness score’ of 95%.
Developed ICH level globalized programs for instrument and method validations and technology transfers.
Responsible for profitability-increased 60% revenue/headcount. Managed budgets of up to 5 million per annum.
AMGEN, INC
Senior Manager, QC Labs February 2001 to September 2007
Managed several teams like lot release, stability testing, sample management including up to 19 direct reports
Handled several inspections from regulatory agencies world-wide.
Particpated in several Six Sigma/Lean projects that saved $1 million for QC lab through work effeciencies( team of eight people handling 80,000 samples/year to 150,000 samples/year).
Standardization of specifications and reference standard testing.
Standardize global procedures for sample handling, chain of custody and processes for critical materials management and analytical methods.
Developed direct reports to take leadership roles. Was able to get 20 employees promoted and transferred at different sites.
Development and troubleshooting of several analytical methods using technology like EIA, RIA, PCR and Threshold DNA and HPLC. Automation using Tecan, Biomex Fx and Hamilton
Validated equipments as required by the Federal Code of Regulations 21CFR Part 11.
Excessive experience with commercial and clinical non-conformance and CAPA quality systems.
Major role in implementation of new LIMS system globally- one site at a time.
Lot release,in process testing and quality systems for Phase I clinical trial drugs.
Extensive experience in environment monitoring, water testing, raw material testing, bio burden and sterility testing.
Expirence with moving the commercial production and quality testing off shore.
Expirence with stability programs and change control for analytical methods and specifications.
Clear understanding of USP, ICH and GxP guidelines and lot release.
Developed training documents for sample management, analytical methods like EIA, Volume, Spectrophotometer, Bradford and appearance
Participated in teams and developed training like Employee Development, Quality By Design, Mentorship, and Organization Change Management.
Developed and participated in several strategies like Preparing the Organization for Future-staff development, Managing resources effectively-leadership development, Six Sigma project for improving sample turnaround times
Responsible for budgets of 2 million and profitability of the organization.
Recipient of Spot Stock Award.
BIOSOURCE INC,
Research Scientist October 2000 to February 2001
Developed Cytokines ELISA Kit.
oShort time as opportunity at Amgen was pending.
SPECIALTY, INC.
Supervisor, Central Quality Laboratory, March 1987 to October 2000
Developed and standardized global quality program for harmonization of analytical methods.
Introduce quarterly quality control program and developed reference standards for over 500 analytical methods.
Developed Quality Assurance program for Sample Management area in the reference lab with sample load of 11,000 samples per day.
Developed and implemented training program for employees and clients
Responsible for 60 employees over two shifts
Participated in CAP and CLIA inspections
Analytical Testing and Managed clinical trials for laboratory testing
Planned and implemented Lean laboratory through automation to increase effeciencies and decrease turnaround times for sample testing.
Design and construction of new facilities, development of testing kits for auto-immune and infectious diseases using PCR and EIA technology in Singapore, Asia
Trained and transferred methods to India
Developed and validated about 300 methods using EIA, RIA, HPLC, PCR and Western Blot techniques
Centrally managed inventory, prepared kits and method transfers for about 500 different methods for production in laboratory
Implemented LIMS system-big change globally.
Transferred and validated various testing instruments like ACS 180, Hitachi, ELAN analyzer, etc. and liquid handling robots like Hamilton, Packard, Biotek and Tecan.
Trained over 50 employees at different levels. Wrote over 100 analytical methods
Education
COLORADO TECHNICAL UNITVERSITY – Colorado Springs, CO
Doctor of Management (Organization Development and Change) April 2013
VILLANOVA UNIVERSITY-On Line Program
Master Certificate in Six Sigma- Master Black Belt in Six Sigma and Lean September 2009
UNIVERSITY OF PHOENIX – Woodland Hills, CA
Master of Management September 2007
UNIVERSITY OF PHOENIX – Woodland Hills, CA
Bachelor of Science (Business Management) April 2005
UNIVERSITY OF GUJARAT – Gujarat, India
Bachelor of Science (Microbiology/Chemistry) April 1980