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Click here or scroll down to respond to this candidateCandidate's Name
Lincolnshire, IL Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLESUMMARYAccomplished analytical product development professional with over 20 years of experience in analytical method development, method validation and quality control testing. Goal-oriented, results driven Project Manager with a robust track record of successfully managing large and complex technical projects. Diverse background in laboratory operations and management of multi- disciplined R&D and QC teams. Decisive leader with proven track record of leading diverse teams and 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. SKILLSDrug Development Project Management Regulatory Affairs Laboratory Operations Management Business Strategy Continuous Improvement Method Development/Validation Technology Transfer CMC cGMP Compliance Problem Solving Strategic Planning Influence and negotiation Conflict Management Change Management WORK EXPERIENCENelson Labs, Itasca, IL July 2023 March 2024Senior Manager, Laboratory Operations Provided strategic and business oversight of the chemistry departments day-to-day operations with a focus on continuous process improvement. Led phase appropriate method development and validation or method transfer to support early phase clinical development to commercialization. Authored/reviewed documentation (methods, SOPs, transfer protocols/reports etc.) to support new and existing commercial products. Acted as study director, consulting with customers, designing protocols and approving studies. Led analytical OOS/OOT investigations and provided guidance in process investigations. Reviewed analytical raw data and result reports, including release and stability data. Ensured effective integration and coordination among team members with a focus on successfully achieving results against set objectives. Worked cross-functionally with Sales and Consulting teams to grow business offerings of the laboratory and increase profitable volume growth.Integrated Project Management Company Inc., Burr Ridge, IL May 2017 July 2023 Senior Project Management Consultant Guided cross functional teams at biotech and pharmaceutical companies for IND, NDA, and BLA submissions. Led creation and execution of comprehensive and integrated project plans for clinical trial readiness in collaboration with Nonclinical, Clinical Pharmacology, CMC, Clinical Development, and Regulatory Affairs teams. Established PMO Toolkit including timeline visualizations, dashboards, target product profiles and RAIDA logs utilizing automation in Smartsheet. Provided guidance to clinical science and data science teams of a pharmaceutical company in development and implementation of Decentralized Clinical Trials initiative. Created a pilot program, conducted workshops to establish current and future state of DCT capabilities. Provided PM leadership to Global Medical Affairs team on global MSL Excellence project. Strengthened global MSL organizations ability to collect, analyze and share MSL generated field medical insights, key intelligence topics and key intelligence questions. Identified key project milestones and dates of project deliverables, identified dependencies and risks in project plans, and managed the effective flow of communication of project updates among stakeholders. Created and maintained quality plans, communication plans, risk logs, project update dashboards, action item logs, budget tracking, and project change control logs. Ensured required activities were performed pursuant to the project schedules. Ensured timely and successful projects completion by assessing critical paths, performing risk management, and executing resource planning. Advanced goals by keeping project teams informed, focused, and motivated. Conducted team workshops and provided training to project teams. PPD, Middleton, WIAssociate Director Oct 2009 - April 2017 As member of senior leadership team drove cross-divisional operational strategies and high- priority process improvement initiatives across organization As head of R&D department directed laboratory operations of multi-disciplined R&D, QC and Stability teams performing method development and validation, extractable/leachable testing, QC and stability testing, ICP-MS metals testing, oligonucleotides testing, and impurity identification using LC-MS; overseeing a staff of 75-80 analysts. Designed and presented operational strategies, business plans, and financial performance reports to executive leadership team. Led global procurement and business development activities for multiple sites by writing and negotiating key contracts and defining the scope of work using competitive pricing based on global market trends. Established and maintained excellent relationships with key clients by consistently delivering high quality results for complex projects. Developed and implemented cross-functional strategies for successful execution of drug development programs at global sites. Assessed critical paths and potential risks for projects to ensure timely completion and quality compliance. Provided 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, laboratory investigations, procedural deviations, OOS/OOT investigations, root cause analysis, and implementation of CAPA. Participated in FDA inspections and client audits. Focused on continuous improvement initiatives: quality, safety, data integrity, operational excellence, efficiency, technical expertise, advanced technologies, and new service offerings. Key Achievements Established a motivated and quality-driven R&D 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%) Significantly improved department quality metrics: First Time Right (FTR) improved from 32% to 54%, Readiness Check Failure (RCF) dropped from 22% to 8% within one year PPD, Middleton, WILaboratory Manager Oct 2006 - Sep 2009 Provided management and strategic guidance to group leaders and technical teams 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. Key Achievements Established Centers of Excellence within R&D group to provide technical expertise and support to entire campus on various technologies. Performed gap analysis for 20 line extension programs of a global pharmaceutical company and successfully managed a large team in accelerated completion of remedial validation for each program Successfully integrated all development and validation activities performed on site enhancing productivity. Championed daily lab safety with no injuries, no near misses, and no issues of non-compliance by staff members.PPD, Middleton, WISenior Research Scientist Oct 2000 - Sep 2006 As technical lead on site for R&D and stability groups provided leadership and guidance to multi-disciplined teams performing analytical method development, validation and routine/stability services, with emphasis on technical performance and efficiency. Drove projects to completion ensuring progress and technical competency. Instructed project leaders on experimental design of projects and drafting of protocols. Performed technical review of weekly status reports, final reports, protocols and analytical methods. Trained staff on analytical method development and validation and regulatory process Provided training and guidance to staff on maintenance and operation of analytical instrumentation and writing procedural and instrumental SOPs. Led problem solving and technical and procedural troubleshooting sessions. Key Achievements Implemented automated software (DryLab) and column switching capabilities on site to increase efficiency during method development and provided relevant training to staff. Streamlined method development process to achieve scientifically sound analytical methods. Expedited method validation process by utilizing multiple analysts and instruments resulting in shorter turnaround times.EDUCATIONJohns Hopkins University, Baltimore, MDMaster of Science, Regulatory ScienceUniversity of Wisconsin, Oshkosh, Oshkosh, WIBachelor of Science, Chemistry, BusinessINDUSTRY LECTURESTwo 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 CERTIFICATIONS, & AFFILIATIONSCertifications: LEAD Certification Six Sigma Preclinical/Drug Product Design Strategies Affiliations: AAPS Analysis & Pharmaceutical Quality Leadership Committee AAPS Chemistry, Manufacturing, & Control Focus Group Industrial Advisory Committee - Milwaukee School of Engineering, Biomolecular Engineering |
