For the second year in a row, Putman Media (Pharma Manufacturing’s parent company) rolled out the top picks for the company’s annual list of Influential Women in Manufacturing (IWIM). Although the awards, which are given on the basis of nominations, call out many women who have risen through the ranks to reach executive positions, they also honor those who serve as mentors and leaders, often paving the way for up-and-comers in their industry.
Among the 27 women named in this year’s winners were two key players from the pharma world. Here are some of their reflections on what’s been critical to their success and what the future holds for pharma.
Owner, senior associate, pharmaceutical market director at CRB, a pharmaceutical manufacturing facility planning, design and construction company
In her leadership role at CRB, Christa Myers works at the forefront of every major manufacturing trend in pharma. But she also makes time to give back to other women in her field through her work with ISPE’s Women in Pharma, a forum she helped launch to promote collaboration and career advancement.
What was the most game-changing decision you made in your career?
It sounds odd, but one of the most game changing decisions that I have ever made was the decision to allow myself to be me, to be wrong, and to be heard: They all go together. There are times in your career that you try so hard to grow past current weaknesses that you forget that you are full of strengths. When you allow yourself to make mistakes, you grow from them. When you allow yourself permission to be wrong, you listen more. When you listen more, you learn more. The amazing truth to business is that the more you listen, the more you tend to be heard.
What is the most exciting frontier in pharma?
Everyone is talking about the growth of cell and gene therapy products. The space is changing and growing on a daily basis. What will happen next? The mini-factories of cell therapy and gene therapy products are all based on enclosing some basic benchtop operations of cell preparations. What technology will turn the entire idea upside down by closing the entire process from patient to patient? The manufacturing of these therapies is changing rapidly with a focus to protect the patient from operator error and environmental impacts. The more closed and controlled the process can become, the better for the health of the patient and the overall cost of the facility and equipment within which it is processed.
Vice president of analytics engineering at Seeq, which provides software with advanced analytics capabilities to the industrial processing manufacturing sector
A chemical engineer by training, Lisa Graham has over 20 years of experience in several manufacturing industries. But her transition to working for Seeq began after she started her own consulting firm, Alkemy Innovations. Now, Graham leads an analytics engineering team that is 50 percent female — bucking the industry norm where just 26 percent of computer engineers are women.
What could be the next big breakthrough in pharma manufacturing?
The most exciting frontier in pharma is innovation related to the emerging needs of patients, specifically how to supply small batches quickly and with consistent quality. This includes the rapid evolution towards continuous manufacturing (CM) to meet these ever-changing supply chain requirements. As we see more companies successfully producing products this way, there is growing evidence to support how CM offers batch size flexibility, streamlined development and smaller manufacturing footprints — all without the old challenges of scaling. The lessened angst around scale-up means we can accelerate the process of development to commercial launch.
What will be the most talked-about issue in pharma in the coming year?
Pharma colleagues are investing even more time and energy into implementing holistic “fume hood to launch” strategies with emphasis on data analytics. It is increasingly possible to bridge the gap between lab-scale, pilot-scale and small-scale commercial manufacturing by leveraging modular equipment and agile process design. These strategies provide business value by building quality into the process, aligning process robustness with process validation, ultimately letting companies be agile as they balance current needs with projected future needs.