Daniel Newton

The company generates waste regulated by federal, state, and local entities. The waste stream is complex, with hundreds of compounds directed throughout the facility for remediation and disposal. Each functional group has a disparate method for handling waste.

During the course of this ever-developing program, I successfully interfaced with and managed stakeholders/team members across three functional groups and two countries, from the C-suite to boots on the ground. This project remains ongoing, with an impact of seven figures in FY 2023 and a currently high six figures in FY 2024.

This project involved generating and verifying a list of all chemical compounds disposed of using the Chemical Abstracts Service's numbers. The reactivity of these chemicals was cataloged and compiled in a database for future reference. Currently, the 2nd and 3rd phases of the project are moving into production using Lean Kaizen methodologies to drive continuous improvement and identify functional bottlenecks while funding the program through a portion of the financial impact, creating a huge net positive financially. Management of this project requires coordination with and compliance with the EU Annex, FDA, EPA, and state-level regulations.

In 2023 – 2024, I undertook a project with a regional biotechnology manufacturing startup. Through the strategic application of Lean, Kaizen, and Six Sigma methodologies, I massively increased manufacturing operational efficiency.

I employed a structured approach that combined principles from each of the methodologies, which I found a great deal of previous success. To ensure buy-in, I worked closely with the operational stakeholders, advocating for the value of lean principles in complex organizations.

During this time, I worked with the team to create value stream maps. Then, I implemented a Pareto analysis of the identified bottlenecks to determine the most appropriate candidates for improvement. Finally, I worked directly with team members to observe and develop an understanding of the process. We identified dozens of potential improvements through Kaizen events and aligned them with the previous Pareto analysis. This allowed the venture to rapidly implement changes that had massive effects on its bottom line.

The venture was previously failing and had less than a year remaining. As of mid-2024, it is profitable and planning for expansion using the principles I successfully championed.

Managed this project for a company that manufactures sterile injectable products for international markets. Over time, through ad-hoc changes, the efficiency of the manufacturing systems and protocols significantly decreased. As a result, a large-scale project to overhaul these systems was initiated with dozens of active participants.

This program required advocating directly with mid-level management and high-level executives to create resources and bring skilled team members on board. Not only were resources successfully created, but I was also able to champion institutional momentum, resulting in a nascent but growing culture of continuous improvement that remained in place after my departure.

Junior members of the manufacturing team identified inefficiencies and presented them to concerned parties. Through applying servant leadership principles, these members were empowered to initiate the process under guidance and were active participants in identifying and engaging stakeholders. The members actively engaged in the process developed professionally and personally and moved on to successfully apply the principles they demonstrated to other functional units within the company.

The company had launched an extensive catalog of products in 2016 and 2017. The high number of products generated significant issues in production efficiency, unacceptable lead times, and considerable team fatigue during product turnaround.

During the course of managing this program for approximately 5 years, I developed and championed a number of projects with great success, creating a culture of communication using TQM, Lean, and Kaizen principles. Due to this company being a startup, resources were limited, but I was able to manage 7-figures in budgetary availability to ensure results. These results were reported to stakeholders regularly, and contributed enormously to the success of the venture.

This program and associated projects involved identifying underperforming products and programs using Value Stream Mapping/Pareto analysis. Then, dozens of customers were interviewed, and voice-of-the-customer (VOC) practices were used to find suitable alternatives. Additionally, process improvements and automation were continually added into the manufacturing environment to multiply the efficiency of the team members, allowing for a highly lean operating environment, producing vastly more products with less staff than competitors.

Currently conducting an ongoing regulatory gap assessment for an international pharmaceutical client transitioning from FDA CFR21 to EU Annex 1. This has resulted in the elimination of dozens of audit liabilities and directly reduced the potential of 6 – 7 figures of fines ranging from major to minor.

From 2023 – 2024, I leveraged my extensive biotechnology operations experience to work directly with operations and quality unit upper management to identify gaps in their compliance with the updated regulatory requirements for drug production. This ranged from quality control practices to manufacturing practices and facility adjustments. As with all projects, I took the opportunity to champion continuous improvement by working with boots on the ground to find additional concerning practices or needed facility improvements.

During this time, I drove a culture of communication and accountability, ensuring that the top-level liabilities were remediated with the highest priority. I also smoothed the way politically through savvy stakeholder management and a culture of servant leadership and respect for all participants.

I managed a diverse project with multiple stakeholder units across a large, 24/7 manufacturing facility, including quality assurance, quality control, HES, supply chain, engineering, operations, and manufacturing. I identified and worked together with stakeholders from each unit seamlessly to accomplish the identification and remediation of waste in the process.

As I have for the last two decades, I led with Lean/Kaizen principles and introduced Six Sigma principles as needed. Throughout the entire project, I spearheaded servant leadership, mentoring and guiding individuals throughout the process to provide a sustainable and long-lasting foundation of operational excellence through Agile-influenced, iterative, continuous improvement. The project wrapped up in the summer of 2024 and continues to provide great value to the enterprise, with potential future projects being negotiated.