Accomplished pharmaceutical product development professional with strong analytical chemistry background, and diverse experience in laboratory operations, strategic project planning, and quality management. Results-oriented, decisive leader with proven track record of developing and implementing robust action plans to facilitate positive change with focus on quality and innovation. Motivated, high energy individual with strong interpersonal skills. Excel in fast-paced, dynamic environments while remaining pragmatic and focused.
As member of senior leadership team at PPD GMP Laboratories drive cross-divisional operational strategies and high-priority process improvement initiatives across organization. As head of R&D department direct laboratory operations of multi-disciplined R&D and QC teams.
Developed and implemented cross-functional strategies for successful execution of drug development programs at global
sites. Assess critical paths and potential risks for projects
to ensure timely completion and quality compliance. Made data driven decisions to achieve quality improvements and operational success. Effectively communicated operational strategies with technical teams, while keeping teams motivated and focused. Provided proactive leadership to managers and technical leaders at global sites in support of manufacturing processes, technology transfer, and process development activities. Provided training and strategic guidance to staff on cGMP compliance, procedural deviations, OOS investigations, root cause analysis, and implementation of CAPA. Evaluated performance and implemented goal setting for teams and individuals, keeping in mind
scientific advancement. Participated in FDA inspections and client audits. Focused on continuous improvement
initiatives: quality, safety, data integrity, operational excellence, efficiency, technical expertise, advance technologies, and new service offerings.
•Established a motivated and quality-driven department resulting in increased annual revenues from $8 million to $18 million over four years
•Substantially improved department productivity by doubling profit margins (from 25% to 50% )
•Consistently surpassed department productivity and revenue goals by maximizing utilization of available resources
As leader of analytical methods development and validation group provided direct management to group leaders and strategic guidance to teams of 20-30 analysts performing activities in support of drug development programs at global sites.
Spearheaded vision, strategy, and execution of project plans for all stages of drug development studies with focus on analytical method development. Provided leadership, coaching, and technical guidance to project teams ensuring efficient execution of operational plans, cGMP compliance, and timely client deliverables. Provided technical support to global manufacturing sites during technology transfer, and process/cleaning validation. Provided coaching, training, troubleshooting and technical support for complex analytical and process investigations. Implemented systems and process improvements to increase efficiency, productivity and quality in laboratory operations. Oversight of OOS/OOT investigations. Served as Subject Matter Expert (SME) to clients' technical and regulatory concerns.
•Successfully integrated all development and validation activities performed on site enhancing productivity
•Established Centers of Excellence within R&D group to provide technical expertise and support to entire campus on various technologies
As on-site technical lead provided leadership and guidance to multi-disciplined teams performing analytical method development and phase appropriate method validation using HPLC and GC, technology transfer, lot release and stability testing, and continuous support of marketed products, with emphasis on analytical process improvements, superior technical performance, and efficiency.
Independently led projects design ensuring quality, cGMP compliance, and technical competency. Provided guidance to project leaders on experimental design of method development, validations, transfers, and drafting of study protocols. Worked with operational teams to ensure successful transfer of analytical methods at global sites. Provided training and guidance to staff on maintenance and operation of analytical instrumentation and writing of procedural and instrumental SOPs. Led problem solving and technical and procedural troubleshooting sessions.
•Decreased method validation turnaround time by 40% by designing validation activities in parallel
•Implemented automated software (DryLab) and column switching capabilities on site significantly improving efficiency during method development
•Established a step-by-step method development process to improve efficiency and achieve scientifically sound analytical methods
Lean Six Sigma Yellow Belt Certification July 2015
LEAD Certification 2013-2014
Preclinical and Drug Product Design Strategies Short Course, University of Wisconsin Madison, Extension Services in Pharmacy, October 2009
Introduction to Regulatory Process Course, Madison, WI- July 2001
Two Dimensional “Iso” LCMS and its Potential Application to support Formulation Development- Forum on Formulation Support at AAPS Annual Conference, New Orleans, LA November 2010
Drug Development and Approval Process- UW Speakers Bureau, February 2008
Member AAPS Analysis and Pharmaceutical Quality (APQ) Leadership Committee
Member AAPS Chemistry, Manufacturing, and Control (CMC) Focus Group
Member Industrial Advisory Committee for Milwaukee School of Engineering Biomolecular Engineering Programs
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