New Berlin, Wisconsin, United States
QA/QC, Product Development, and Project Management Professional. Professional Skills: - Auditing - Budgeting - Clinical Trials - Collaboration & team-building - Continuous Improvement - Document Control - Formulation, Specification Design, & Testing - Process Design, Optimization, and Implementation, SOPs - Product Development : Benchtop, pilot & Scale-Up (solid dose, powders, liquids) - Product Sensory Evaluations, Focus Panels, Data Analysis - Project Management & Strategic Planning - Quality Assurance & Quality Control - Regulatory Compliance (cGMP, supplements & medical devices) - Resource & Personnel Management - Supplier management - Testing - Training
• Strategic project management to ensure delivery of projects on time/within scope utilizing End-2-End /Stage Gate process. • Led two cross-functional 5-10 member product portfolio working groups, project managed average of 25 individual concurrent projects • Recommended & implemented corporate-level and cross-departmental process improvements • Managed product development execution platform including system maintenance, administration, and delegated project responsibilities. • Affiliations: Project Management Institute (PMI) member (June 2017-present) • Specific Accomplishments o Led successful completion of commercial development/launch of four new dietary supplement products, including two novel flavored protein powder blends developed as Product Development Coordinator
• Directed development, concept through launch across three commercial product lines. Led cross-functional team (10) • Designed & established product, process, and packaging specifications • Formulated/co-formulated products • Managed new ingredient and vendor sourcing and material qualification processes • Led identification, qualification, selection, and development of contracts with 3rd party contract manufacturers • Conceptualized, designed, and implemented new processes & procedures • Manufactured proof-of-concept bench-top and pilot batches and led scale-up • Problem-solved product manufacturing and quality issues, identified and implemented product and process improvements, Key Performance Indicators • Ensured compliance to regulatory requirements (cGMP, FDA, Health Canada, IRBs, organic, labeling, New Dietary Ingredients-NDI) • Authored and maintained SOPs and records in compliance with regulations total management system • Co-developed product substantiation/compliance documentation, led compliance review process • Measured, evaluated, and reported performance vs metrics • Designated and coordinated product testing • Designed and conducted internal and external sensory evaluations, designed sensory specifications, led training • Drafted product labels • Conducted personnel training • Managed new product development laboratory and pilot manufacturing areas • Co-managed day-to-day workload for 2 R&D personnel • Managed capital and expense budgets • Specific Accomplishments o Led launch of 35+ new products across 3 product lines (2007-2017) o Conceptualized and led time/cost-savings focused projects: Re-design of product development processes, targeted software and equipment implementations, database development
• Led day-to-day operations of industrial QC Microbiology laboratory. Led Microbiology staff (3) / media prep lab staff (3) • Ensured compliance to regulatory requirements (cGMP - FDA 21 CFR Part 111-dietary supplements) • Reviewed and approved laboratory test results, oversaw product release, coordinated investigation of customer complaints • Created & implemented laboratory new processes, including authoring cGMP Standard Operating Procedures (SOPs) • Implemented process improvements yielding time and cost savings • Led implementation and validation of laboratory-related equipment and testing methodologies • Conducted interviews and provided hiring recommendations, conducted staff annual performance reviews • Managed laboratory inventory including sourcing • Assisted with laboratory testing as needed to ensure on-time results availability • Created monthly and yearly departmental performance summaries for reporting to top management • Specific Accomplishments o Co-developed & implemented custom laboratory sample tracking & results reporting software application similar to LIMS o Rapidly promoted to supervisor after 2 years (1 year as microbiologist (2003-2004), 1 year as senior microbiologist (2004-2005)