Meet Bill Monteith, PCT's New Chief Operating Officer

William Monteith, Chief Operating Officer, Hitachi Chemical Advanced Therapeutics Solutions | November 24, 2015

Bill_Monteith.jpgWilliam (Bill) Monteith joined PCT in October, 2015. He is a dynamic global commercial pharmaceutical Operations and Quality Executive with a documented record of organizational success and a proven record of accomplishment in strategic planning and execution, business process improvement, cost reduction, FDA and DEA regulatory compliance, facility startup and turnaround, technical transfer and analytical method validation, supply chain, and multi-plant management.

Before joining PCT, Bill was VP and General Manager, and then Executive VP, Technical Operations, at the commercial cell therapy biotechnology company Dendreon Corporation. He has also held leadership roles at Sandoz, Shire, and Wyeth pharmaceuticals, ranging from technical operations to quality assurance.

Bill is a member of the American Chemical Society, the American Society of Quality Professionals, the American Society of Pharmaceutical Scientists, and the International Society of Pharmaceutical Engineers. He received his BS in Chemistry from Saint Lawrence University in Canton, NY.

Can you explain your role at PCT, including responsibilities and objectives?

I am very pleased to have joined PCT in October as the Chief Operating Officer based out of PCT’s Allendale, New Jersey headquarters. In this role I am responsible for PCT’s Manufacturing Operations, Quality Assurance/Quality Control, Facilities, Materials Management, Project Management and Manufacturing Sciences and Technology departments. My main objective is to work with the team to continue to build PCT into the premier contract manufacturing organization for cellular immunotherapy, gene therapy and stem cell work for both clinical and commercial clients within the industry.

How does your previous experience in Quality Assurance influence or impact your current outlook on the business?

My previous Quality experience was at a big pharma company that had just gone under a consent decree. Even though the exact facility I was at was not directly part of the consent decree, a consent decree impacts the entire organization. We had to make our quality systems more robust. Teamwork was required to assure that this happened. The most important lessons I learned out of that experience that impact my decision making to this day are:

  • There is a cost that companies pay for being non-compliant—so do it right the first time.

  • Quality is everyone’s responsibility, not just those in the department that bears the Quality name.

  • Quality and compliance must be built in to every process and design, from the early development stage through commercialization. The FDA wrote a whole guidance on this, called Quality by Design.

  • Companies must have strong, robust business and quality systems, as well as processes and procedures that are practical and easily understood and followed, in order to achieve sustainable compliance.

  • Technical Operations decisions that do not consider impact from a Quality perspective can cost the company money, and can result in regulatory action and harm to the company’s reputation

I am pleased now to bring this knowledge to PCT, an organization that is already strongly commited to Quality by Design principles, and to be a part of the continued drive to focus on Quality.

What have you learned about successful cell therapy commercialization from previous roles that you bring with you into your role at PCT?

I have  accumulated a wealth of learnings related to  commercialization of cellular immunotherapy from my many years of experience in this industry. If I had to pick some key areas of importance, I think they would be:

  • Make/buy analysis for manufacture of your product. Is the return on investment greater with outsourced manufacturing versus building infrastructure and manufacturing it in-house? Cellular immunotherapy manufacture in a cleanroom environment can be very costly.

  • Understanding that cost of cell therapy manufacturing is not the only concern. What is needed is a commercial manufacturing strategy that takes into account quality, cost of goods, scalability, and sustainability. This means that cell therapy developers must plan ahead. Working through facets such as scalability and sustainability at an early stage can provide significant cost and time advantages as a cell therapy moves along in its clinical process.

  • Sound characterization of the product’s critical parameters during the development stage—know your product and process!

  • Thorough pressure test of the marketing forecast—forecast inaccuracy can mislead a management team to make costly decisions.

  • Understanding process drivers for cost of goods during the development stage—look for opportunities such as process and laboratory automation early on. The most efficacious product in the world won’t sell if patients can’t afford it and insurance companies or the government won’t pay for it if it is too costly.

  • Do thorough market research to understand how your customers—patients, physicians and the government—will view your product. The understanding of cellular therapy in the medical and public community has come a long way. In the early days I had heard it referred to as “Voodoo” medicine. Mechanism of action needs to be clearly understood and the public must be educated.

What is your leadership style?

I would describe my style as calm, intuitive, striving to build consensus, but not afraid to make an informed decision if consensus cannot be reached.

I believe that a good leader makes his or her own job obsolete. By that, I mean they build strong, well-trained teams that are extremely effective in running the business and dealing with situations that arise, whether the leader is there or not. So building strong teams is my first priority and something that PCT has already distinguished itself in. To get strong teams, I think as a leader you have to be a good listener and understand what the team needs in order to be successful in the way of support, tools, and resources. Respect has to be built along with trust. A team has to know each other and trust each other well enough to be vulnerable, while being frank and open in sharing their opinions in meetings. This is especially important during conflict. Conflict isn’t a bad thing when the team knows how to have constructive conflict—this is how the team and the company grows and deals with change. Most of my teams will be given a copy of Patrick Lencioni’s book, “The Five Dysfunctions of a Team," as the author does a great job addressing these issues in regards to team building

William Monteith, Chief Operating Officer, Hitachi Chemical Advanced Therapeutics Solutions

William Monteith, Chief Operating Officer, Hitachi Chemical Advanced Therapeutics Solutions William is a dynamic global pharmaceutical Operations and Quality Executive with a documented record of organizational success and a proven record of accomplishment in strategic planning and execution, business process improvement, cost reduction, FDA and DEA regulatory compliance, facility startup and turnaround, technical transfer and analytical method validation, supply chain, and multi-plant management.

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