Dean Kramer, MS, MBA, CBBSS

Experience

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  Alliance Group

  Jan 1991 - Jan 1992

  Lab Technician

  Analyzed samples for chemical constituents using a variety of instrumentation and wet chemistry techniques. Responsible for notebook review, quality control data review, and report generation.

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  University of Wisconsin-Madison

  Jan 1991 - Jan 1992

  Lab Technician

  Studied the cascade effects of nutrients evolution in fresh water ecological systems. Responsibilities included study initiation, sample collection and logging, sample preparation, sample analysis, and data entry. In charge of routine maintenance and ordering supplies for the Lachet Nutrients Lab

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  U.S. Geological Survey (USGS)

  Jan 1992 - Jan 1993

  Enironmental Consultant

  Researched and analyzed total and available nutrients for a stream/storm runoff project. Performed all the duties of a lab technician, including sample collection, solid/liquid phase extractions, data analysis, and report tabulations.

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  University of Wisconsin-Madison

  Jan 1994 - Jan 1996

  Laboratory Manager and Academic Staff

  Managed the Center for Waste Management, an environmental consulting group. Responsible for heading up numerous environmental fate, waste reduction/disposal, and alternative planning projects. Performed all supervisory duties including a full range of recruiting activities, performance evaluation, career development growth, routine instrument maintenance, fiscal budgeting, and ordering supplies, as well as monitoring and complying with OSHA regulations. Responsible for methodology development, quality assurance/quality control data review, complying with operating procedures, report publication, and safety.In addition, taught two upper level courses on Solid Waste Management and Waste Water Treatment for the College of Natural Resources. Show less

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  Thermo Fisher Scientific - Nicolet Instruments

  Jan 1996 - Jan 1998

  Customer Support Application Chemist

  Utilized expertise in Fourier Transform Infrared and Raman spectroscopy to provide hands-on experience and training for customers around the United States in a multitude of different industries (including pharmaceutical and military). Reviewed customer analysis methods/applications, provided troubleshooting services, and interrupted results, as well as customized new analysis methods for improved accuracy and efficiency. Coordinated training programs, manuals, and professional presentations for nationwide seminars and onsite company presentations. Aided internal product testing/development, development of markets, software validation for GLP/GMP facilities, and maintained a customer database. Oversaw and developed resources for the growth of the Training and Application Show less

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  Covance

  Jan 1998 - Jan 2002

  In addition to Operation Supervisor 109 duties, responsibilities include: lead process efficiency committees (Six Sigma Projects), harmonize operating procedures across pharmaceutical research departments, host clients and regulatory agencies, develop and implement financial business plans, forecast revenue targets, develop annual budget, lead departmental meetings, and oversee ISO 9000 audits. Also responsible for creating training program/training files, overseeing software and application validation efforts for CFR 21 Part 11, developing departmental intranet site, and performing application programming efforts. Show less Directed operations for in vivo and in vitro pharmaceutical research under the Good Laboratory Practices (GLP) in the spirit of the Good Manufacturing Practices (GMP) in compliance with OSHA, EPA, FDA, NRC, DNR, and state/local agencies. Lead, planed, and organized day-to-day laboratory operations in an efficient, error-free manner while in compliance with appropriate standard operating procedures (SOPs). Ensured personnel, equipment, space, and support resources for current and new client studies, as well as performs all supervisory duties including a full range of recruiting activities. Evaluated all work contracts, employee orders, and project Profit & Loss. Also responsible for setting up training standards, writing Standard Operating Procedures (SOPs), and Quality Control. Show less

  • Operations Supervisor 110

    Jan 2000 - Jan 2002

  • Operation Supervisor 109

    Jan 1998 - Jan 2000
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  Ortho Molecular Products

  Jan 2002 - Jan 2013

  Responsible for providing leadership and strategic direction to the manufacturing facility. Provides overall direction of the Manufacturing, Supply Chain, Inventory Control, Receiving/Warehousing, Purchasing, Planning, Labeling, Distribution, Maintenance/Machine Repairs, Process Engineer, Quality Assurance/Quality Control and Building Grounds, as well as all related staffing, and resources responsibilities in the manufacturing of Nutraceuticals under GMP compliance. Responsible for the Quality Department and all the activities revolving around testing, auditing, approving, and rejecting of documents, procedures, product, components, packaging materials, and labels. Financially responsible for the day-to-day operational functions, as well as short/long term strategic company planning and budgeting. Maintains a loyal and collaborative environment where people are treated fairly and honestly at all levels and promotes character-based values. Responsible for continuous improvement of efficiency, error reduction, cost control, and utilization and oversees Six Sigma Black Belts. Provides collaborative leadership that fosters an organization focused on Best Practices and regulatory compliance. Coordinates and drives all activities to support company objectives and profitability through sales, manufacturing, marketing, product development, quality, and general management functions. Also responsible for the Contract Manufacturing business and all related selling and operational activities. Show less Directs and leads a discrete manufacturing facility that produces and distributes nutraceuticals to health care professionals. Oversees Manufacturing, Supply Chain Management, Receiving/Warehousing, Purchasing/Scheduling, Labeling, Fulfillment, Information Technology, Maintenance/Machine Repairs, Building Management, Contract Quoting, Customer Service and Order Entry departments, as well as all related staffing, resources, and functions related to human resources. Direct and oversee product production and distribution under regulatory Good Manufacturing Practices (GMP) compliance. Financially responsible for the day-to-day operational functions, as well as short/long term strategic company planning and budgeting. Developed “Winning” teams that delivered results. Show less Directed the Quality Assurance and Quality Control departments (personnel, budgets and capital). Responsible for all regulatory compliance for the manufacturing of Nutraceuticals under Food and Drug Administration (FDA) Good Manufacturing Practices (GMP). Oversaw the approval/rejection of all components received, in-process materials, packaging materials, labels, and finished products released. Managed approval/rejection of all manufacturing records generated, all investigations performed and that all components received / finished products released meet quality specifications. Reviewed and approved all procedures or specifications that impact the identity, strength, quality, and purity of the finished product. Directed day-to-day quality operations, defining budgetary needs, and developing business strategies to support quality efforts and process flow. Assessed quality initiatives by organizing, leading, and implementing process efficiencies and institutes improvements. Harmonized operating procedures across departments, and hosting regulatory agencies. Developed and implemented training programs that provided the necessary knowledge and experience. Also responsible for overseeing all quality audits and reporting deviations to the leadership group. Show less Managed Quality Assurance and Quality Control departments in the manufacturing of nutraceuticals. Responsible for regulatory compliance under appropriate Good Manufacturing Practices (GMP), overseeing day-to-day quality operations, developing business strategies to support quality efforts, and process flow. Assessed quality initiatives revolving around approving/rejecting all components received, in-process materials, packaging materials, and all finished products released. Reviewed production records and analysis results generated in the laboratory to make sure errors have not occurred, or if they have occurred, that they have been fully investigated. Show less

  • Vice President of Operations

    Jan 2007 - Jan 2013

  • Director of Operations

    Jan 2004 - Jan 2007

  • Director of Quality

    Jan 2002 - Jan 2004

  • Manager of Quality Assurance and Control

    Jan 2002 - Jan 2002
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  Provident Nutraceutical a Division of Ortho Molecular Products

  Jan 2014 - Jan 2018

  President Provident Nutraceutical a division of Ortho Molecular Products

  Responsible to grow top line revenues profitably, while adhering to corporate values. Also responsible for providing strategic leadership for the company by working with the Board, CEO, and other management to establish long-range goals, strategies, tactical plans, and policies. Carries out and delivers on the corporate objectives and tactical plan that are developed as part of the strategic planning process. Responsible to provide collaborative leadership that fosters an organization focused on customer care, best practices & process refinement, and regulatory compliance. Also responsible for organizational fiscal functions and performance, while developing strategic partners. Enhances and/or develops, implements and enforces policies and procedures of the organization by way of systems that will improve the overall operation and effectiveness of the corporation. Effectively develops solutions that alleviate risk and create the greatest gains to business challenges and opportunities. Effectively recruit, develop, and retain key hires within the organization. Models both high morality and high character; that communicates and reinforces vision, mission, values, and culture. Develops customer partnerships that collective serve one another. Facilitates cross-departmental collaboration that strengthens internal communication with staff; creates and promotes a positive work environment that supports consistency throughout the organization to achieve customer satisfaction and departmental efficiency. Responsible for implementing and monitoring the budget to ensure that sound financial controls are in place, that the flow of resources enables continuous progress towards the achievement of the company mission, and that funds are allocated properly to reflect present needs and future potential. Show less

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  Ortho Molecular Products

  Jan 2019 - now

  Provides strategic leadership and coordination for business process transformation by partnering with all business unit leaders, focusing continuous improvement culture and related value stream activities on effective and efficient simplification and optimization of processes and systems, so that long term business objectives can be sustainably accomplished while embracing the vision and mission of the company. Leads and champions the operational excellence and continuous improvement culture to support the company’s strategy and business objectives. Introduces and implements structured and disciplined methods and tools for continuous improvement and provides training to employees to establish and maintain a continuous improvement culture. Drives “bottom-line” performance improvement in critical operational performance areas such as cost, labor productivity, customer service, quality, safety, compliance, capacity management, and inventory management. Develops and designs a best-in-class lean continuous improvement organization, processes, and procedures based on expert understanding, industry experience and insights into future direction. Accountable for developing appropriate Core Value Drivers, KPI’, and operations metrics, so that operational effectiveness can be tracked. Oversees Continuous Improvement, Business Intelligence, Informational Services and Development, and Operational groups. Show less

  • Chief Administrative Officer (CAO)

    Aug 2024 - now

  • Executive Vice President of Continuous Improvement

    Jan 2019 - Sept 2024