Microbiologist Vanessa Figueroa talks about the twin challenges of building talent and good communication across pharma manufacturing

Vanessa Figueroa, a pharmaceutical microbiologist and consulting partner, has more than 12 years combined experience in pharmaceutical, biotechnology and medical device industries. Vanessa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. A year ago, Vanessa joined Eureka for a Q&A on latest trends in environmental monitoring. She joins us again, in advance of Charles River’s 2019 QC Micro Summit, where she will be a featured speaker.

Eureka: How has your career and industry experiences helped make you a subject matter expert in your field?

VF: My career has been a wonderful journey thus far, affording me with opportunities to engage with many different cultures, many different types of products, and also various regulatory agencies. I started my career working with combinational devices and moved into sterile injectables, but also have worked with oral solid dosage, other medical devices and biologics too. Exposure to different types of manufacturing processes gives me the chance to think differently, and apply microbiology principles in a new way. This then allows me to work cross-functionally, determine what is relevant and important for a given process but also to know when the level of microbiological control is appropriate. Not all products and process require the strictest level of microbial control, and therefore navigating this evaluation process requires skill and in depth understanding of science as well as compliance.

Eureka: What do you feel are the biggest challenges currently facing your industry?

VF: Building the workforce of the future. We need talent in this industry who can think in new and different ways, because the products that are being developed have never been manufactured and tested before. This requires not only proper education and training but most importantly, our workforce requires critical thinking skills like never before. Professionals on all levels must be able to appropriately apply regulatory standards to the new products but also be on the forefront of creating new ones. This means new standards, new guidance documents and new test methods. It may be controversial to say, but I believe in some aspects of the industry, we have never been properly prepared with regards to talent, and we have all felt the repercussions of that. However, knowing that major change is already here, we must adapt rapidly and be immediately open-minded to new ways of learning and growing. This means companies must engage with academia (and vice versa), they must support new talent by providing meaningful training programs while also encouraging bold, new ideas.

Eureka: Can you highlight the most important aspect related to current industry changes and/or trends?

VF: The industry is large, and all changes are important, but I prefer to take this opportunity to highlight something in microbiology. I would like to believe that the trend for adopting new test methodologies has been important for many years now, and arguably even decades. However, I still feel that some companies have been really hesitant to adopt these new technologies. Rapid microbiological methods or even alternative methods are now more widely available for testing various microbial attributes of a product than ever before. It has been my experience that regulatory agencies are very accepting of these technologies and I think the trend to adopt them on a local, company level needs to make significantly more progress. Ultimately, the goal is a method that is reliable, yields strong data in an expeditious manner, and helps us to make sound quality decisions on a routine basis. Some of the more traditional methods leave us lacking with regards to reliable, trending data points. We have the chance to improve upon this by selecting newer methodologies.

Eureka: What do our colleagues within the industry need to be doing differently in their day-to-day?

VF: Improve communication! Communication is really the key to all strong relationships, correct? This shouldn’t differ in the workplace, and it’s especially important in pharmaceutical manufacturing. Our industry manufactures lifesaving products that impact patients and their families. To ensure the supply chain isn’t affected, products must be made right the first time, and comply with strict regulatory standards. Communicating to each other within a department, and also communicating with other departments is essential. Each batch of product requires intense coordination to be successful, and so we must learn to communicate well with each other. This means daily huddles, open door policies, having difficult conversations and holding each other accountable. I truly believe if we all communicate a little more, and a little more clearly, we would see improvements with throughput. Take sample management. The coordination needed to get a sample of product from the manufacturing line to the quality control laboratories for testing and release can be complex. Chain of custody and sample conditions must be maintained at all times, and all pertinent data associated with the sample must be accurate. In order for this to happen, many personnel are typically involved with one sample submission, so making sure these folks communicate is essential for the sample to be properly tested, and on-time, ultimately assisting with final batch release.

Vanessa Figueroa is currently a consulting partner at Quality Executive Partners, where her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Vanessa has a Bachelor’s degree in molecular biology from State University of New York at New Paltz, and a Master’s degree in molecular biology and microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Meet Vanessa and other industry thought leaders at our 2019 QC Micro Summit in Charleston, SC, September 24-26, 2019.

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