Kristi Coley-Stephan Email and Phone Number

As a Consultant at IPM Integrated Project Management Company, I play a key role in guiding organizations through the successful implementation and execution of critical projects and complex initiatives. With a focus on the medical device industry, I lead projects from planning and scheduling to control activities, ensuring the fulfillment of identified objectives. My responsibilities include applying technical, theoretical, and managerial skills to meet project requirements and managing projects within established scopes, schedules, and budgets. With a focus on EU MDR regulatory compliance, I work closely with global medical device companies to ensure remediation and compliance to standards. Effective application of Agile, Waterfall and hybrid project management methodologies across a variety of Project Management Software platforms.

As Manufacturing Supervisor at DiaSorin Inc., I led teams of up to 12 members, optimizing capabilities through targeted training and fostering a collaborative culture. I oversaw In Vitro Diagnostic Regulation (IVDR) assay kit manufacture across multiple kits, addressing challenges through troubleshooting. Managing quality control within the QMS platform (SmartSolve), I ensured compliance, overseeing non-conformance and CAPA workflows. Through cross-functional collaboration, I successfully met tight timelines in a cost-effective manner, emphasizing efficient communication and resource optimization

As a specialist in recombinant antibody production and project/ program management, I optimized processes and allocated resources efficiently to drive efficiency. I had a proven track record of evaluating and implementing novel technologies, enabling high throughput production capabilities.Key Contributions:-Collaborated across multidisciplinary teams to deliver custom products for high-priority customers.Successfully managed projects with confidential information and stringent timelines, ensuring product success.-Led the building and training of effective teams, distributed workloads, and provided ongoing coaching to team members.-Developed communication tools for project tracking and reporting, significantly enhancing visibility and coordination.-Implemented data management tools, resulting in a remarkable 60% reduction in production timelines and costs.My expertise involved balancing technical acumen with strategic leadership, resulting in streamlined operations, cost savings, and the successful execution of projects.

Led the de novo creation of advanced recombinant antibody technology, overseeing the entire lifecycle from initial feasibility assessments through to the successful production and manufacturing handoff. This project has resulted in over $5M sales, to date.My role involved:Conceptualization and Feasibility: Initiated and drove the conceptualization phase, ensuring comprehensive feasibility studies were conducted to lay the foundation for successful antibody technology development.Technological Advancements: Spearheaded the integration of state-of-the-art technologies, staying at the forefront of advancements to enhance the quality and efficiency of recombinant antibody production.Cross-Functional Collaboration: Collaborated seamlessly across multidisciplinary teams, including research, development, and production units, fostering a unified approach for optimal project outcomes.Quality Assurance: Maintained a stringent focus on quality assurance throughout the process, implementing robust measures to guarantee the final product's efficacy and reliability.This comprehensive approach resulted in the successful creation of cutting-edge recombinant antibody technology, demonstrating a commitment to innovation, quality, and cross-functional collaboration.

Development, optimization and delivery of post-secondary advanced science curriculum. Teaching groups of 15 students to successfully pass AP science tests (AP Biology, AP Chemistry, AP Physics). Recruiting, interviewing, hiring & coaching employee teachers.

Development & implementation of novel high throughput Transient Transfection technique. Work with optimization of cell growth through cell line engineering & cell culture media engineering. Analysis & investigation of multiple cell culture vessels, including custom built bioreactors & cell factories.

Recombinant protein expression and optimization of expression in eukaryotic cell lines. Broad experience in Molecular Biological techniques: qPCR, real Time PCR, PCR, RNA extraction, PCR, primer design, Restriction Digests, Ligation, Cloning, Transfection, Cell Culture with a variety of mammalian cell lines. Method Development, SOP creation, work in a cGMP environment.