Management of people and process within the Global Quality organization, specifically providing oversight for the Global Marketing Affiliates - OUS and being the link between the Global Logistics organization and Marketing Affiliates/ Partners. Responsibilities include oversight of global marketing affiliate partners to ensure the highest standards of compliance for all logistical activities for commercial products; relationship building with logistics service providers, and affiliates;… Show more Management of people and process within the Global Quality organization, specifically providing oversight for the Global Marketing Affiliates - OUS and being the link between the Global Logistics organization and Marketing Affiliates/ Partners. Responsibilities include oversight of global marketing affiliate partners to ensure the highest standards of compliance for all logistical activities for commercial products; relationship building with logistics service providers, and affiliates; development and oversight of internal/ external distribution planning, shipping lane solutions, monitoring partner performance, metrics, mitigation and triage of critical logistics issues. Qualifying suppliers for use including authoring quality agreements, external approval of IQ/OQ/PQ logistic solutions; ensuring Quality representation on technical and commercial projects; providing guidance to ensure compliance to regulatory requirements; supporting internal quality systems including change control, deviations, CAPAs, training, document management, complaints, and Annual Product reviews; participate in business reviews Show less

Quality oversight for the Lilly marketing affiliates OUS globally with responsibility over logistics and distribution.

We are a team of brand advisors and consultants with deep expertise in both quantitative and qualitative research that helps companies like yours drive innovation and fuel growth through brand strategy.As a strategic partner for our clients, we work in a collaborative environment to help solve business challenges using design thinking, customer-focused research, data, and ideation workshops.Based out of the midwest, we have worked with hundreds of clients across the country to… Show more We are a team of brand advisors and consultants with deep expertise in both quantitative and qualitative research that helps companies like yours drive innovation and fuel growth through brand strategy.As a strategic partner for our clients, we work in a collaborative environment to help solve business challenges using design thinking, customer-focused research, data, and ideation workshops.Based out of the midwest, we have worked with hundreds of clients across the country to transform their brand processes, communications, employee experiences, and market strategies. With over 15 years of industry and business experience, we’ve developed an approachable, customizable, and collaborative process that gives brands clarity and inspires innovation. Show less

At BoldThink we create brands. We work with businesses to help ensure they have what it takes to be a leader in their industry. Our success is based solely on whether our clients succeed. From brand consulting, strategic planning, design and marketing, we help our clients every step of the way. Let us know what we can do to help your business grow.

Advisory board member helping guide objectives of the Organizational Leadership Department at IUPUI.

Managing and providing oversight and guidance to our external manufacturing and supplier labs in the Americas (Latin America and North America). Responsiblities include: oversight for parenteral manufacturing, laboratory certification and method transfer reviews.

Biologist. Applied theoretical and scientific knowledge to complex experiment design for early and late stage, small and large molecules, development compounds, raw materials and components for quality control microbiology. Detail oriented, organized and an in-depth experience in project planning and use of Six Sigma methodology to support the logistics, commercialization, up scaling, verification testing and bench-scale production of an innovative product pipeline. Global industry… Show more Biologist. Applied theoretical and scientific knowledge to complex experiment design for early and late stage, small and large molecules, development compounds, raw materials and components for quality control microbiology. Detail oriented, organized and an in-depth experience in project planning and use of Six Sigma methodology to support the logistics, commercialization, up scaling, verification testing and bench-scale production of an innovative product pipeline. Global industry expert for the development of endotoxin compendia method verification with a thorough understanding of the regulations for verification of the Anti-Microbial Effectiveness, Sterility, Particulates, Bioburden, Purity and Microbial Contamination testing as applied to the pharmaceutical industry.Thrive in project-oriented, independent environments that require innovative and out of the box problem-solving solutions.Excel in forging key partnerships and leading teams towards innovative outcomes. Writes technically complex documents, protocols, verification plans and research summaries in a manner that is concise and easy to understand and follow. Show less

Development microbiology for Global Quality. Commercialization and Regulatory review planning and project management. Alignment of testing plans and quality standards throughout Lilly, with affiliates and third party manufacturers/testing labs. Bacterial endotoxin, MFI for container closure, dye ingress testing development expertise. Technical writer/reviewer of Product verification packages, Standard Operating Procedures and Equipment Qualifications IQ/OQ/PQ. Six Sigma team project member, Lab… Show more Development microbiology for Global Quality. Commercialization and Regulatory review planning and project management. Alignment of testing plans and quality standards throughout Lilly, with affiliates and third party manufacturers/testing labs. Bacterial endotoxin, MFI for container closure, dye ingress testing development expertise. Technical writer/reviewer of Product verification packages, Standard Operating Procedures and Equipment Qualifications IQ/OQ/PQ. Six Sigma team project member, Lab Safety Representative, Equipment Coordinator. Show less

Microbiological and endotoxin compendial method verification support scientist for parenteral manufacturing, global sites and affiliates, while adhering to cGMP's using aseptic technique.Write and investigate laboratory events (deviations) and OOS and OOT results. High through-put routine testing of product and water.

Contribute to the R01 Abstract for NIH grant submissionConducting investigative tasks in support of NIH grant for the study of persistent subclinical endotoxemia resulting from chronic infections that have been causatively linked to atherosclerosis and cardiovascular disease. These tasks include research of endotoxin methods for detection in blood serum samples, laboratory set up, protocol creation, testing samples, analyzing and summarizing data and training of principal research scientist… Show more Contribute to the R01 Abstract for NIH grant submissionConducting investigative tasks in support of NIH grant for the study of persistent subclinical endotoxemia resulting from chronic infections that have been causatively linked to atherosclerosis and cardiovascular disease. These tasks include research of endotoxin methods for detection in blood serum samples, laboratory set up, protocol creation, testing samples, analyzing and summarizing data and training of principal research scientist / lead investigators. Show less

decommissioned the pork insulin processaided in the production of insulin for stockpiling / inventory to support transfer of activities to Biosynthetic Human Insulin