On Tech Ethics Podcast – Advancing Your Skills and Career in Biotech

Daniel Smith: Welcome to On Tech Ethics with CITI Program. Our guest today is Tammy Mandell, who is the director for the education and training programs at Biotility, which is a leader in biotech education and training. Tammy has more than 12 years of combined academic research and industrial biotechnology experience and is fluent in the techniques methodology and regulatory compliance relevant to the applied sciences. Today we are going to discuss how you can leverage bio utility’s educational offerings for talent development and career growth in the biosciences. Before we get started, I want to quickly note that this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have any questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests. And lastly, I want to note that CITI Program has partnered with Biotility to offer various online courses available via citiaprogram.org. And on that note, welcome to the podcast, Tammy.

Tammy Mandell: Thank you for having me.

Daniel Smith: It’s wonderful to have you. To get started, can you tell us more about yourself and how you got involved in biotech education?

Tammy Mandell: Sure. For years I conducted research in academic settings, both at Princeton University and the University of Florida. And then ultimately I was recruited to work in a gene therapy company, and I noted when I made that transition that my traditional curricula preparation really hadn’t prepared me for industry careers, so I went back to school and earned my master’s degree in curriculum and instruction and really focused all of my projects on really bettering or improving on how we can teach students for these career opportunities.

Daniel Smith: That’s really interesting. For our listeners who might be interested in working in biotech and making that career transition or starting their career in biotech, can you provide a brief overview of some of the key roles in the industry that they might start in and then move into throughout their careers?

Tammy Mandell: I’m really glad you asked that question because I think a big part of even going into these careers is being aware of what those opportunities are. I know that when I was going through school and growing up and loved science, nobody ever really spoke to me about working in the bioscience industries. And there are so many rewarding and meaningful career paths within these organizations.

For example, you can work in the research and development group, which is really focused on discovering and then building out how we can maybe make a new product or service. A lot of work goes into that. You can go into the quality control unit, which is the unit that tests the raw materials and process samples and the finished products that are coming out of these companies, really making sure that they are safe and efficacious for use by the public. You can work in biomanufacturing, which is of course the unit that’s making the product. And a lot of different skills and competencies go into these roles. It really depends on what the product is that the company is making. But really one of the bigger pieces is understanding that when you’re working in these roles, you’re working under federal regulations such as good manufacturing practices, which are really put in place to ensure that these products that can impact a human life are made in a controlled fashion so that they are indeed safe and efficacious.

Daniel Smith: To go off of that a bit, is there a traditional pathway to this type of work? And it sounds like based on what you were saying, it might be a mix, so I’d like to hear more about that and then also what people can do to get into this field.

Tammy Mandell: Historically, the industry has used the bachelor’s degree as the benchmark for entry into these roles and the traditional bachelor’s programs, although they teach the scientific concepts and some of the skills, they really don’t speak to the regulatory compliance and the culture of working in the industry. And there’s a bit of a gap from coming out of a traditional bachelor’s program, bachelor’s science program, and going to work in the industry.

Over the years, there have been fantastic two year degree programs that have been established throughout the country, and they’re very committed to really focusing in on, what are the competencies and skills that have required in the industry? I think most of us have learned science in the context of academic research, and it’s a bit of a paradigm shift to even learn how to teach science in the context of industry careers. Again, coming back to then these really good two year degree programs. A follow on to that is that there are now some really fantastic high school programs that are offered all over the country and typically they’re a three-year sequence. And students in high school are learning techniques that I didn’t even learn in college and beyond. And not only are they learning the techniques, they’re learning the theory behind these techniques and how they can be applied to the discovery manufacturer and testing of these products.

Daniel Smith: Are there any resources out there that you’re aware of, where people can learn more about these two-year programs and also the high schools that offer these programs as well?

Tammy Mandell: A wonderful resource is InnovATEBIO and this is funded by the National Science Foundation and it represents a consortia of education and training programs throughout the country. And within that, there are many, many resources not only about the careers in the industry, and for that I would recommend biotechcareers.org, which is also funded by the National Science Foundation, but within InnovATEBIO, they also have resources for learning, resources for educators and resources for just learning more about what these careers are.

Daniel Smith: Wonderful. I will be sure to include those resources in our show notes so our listeners can check them out. Now I want to shift gears and talk more about Biotility and BACE, as I know you all have many resources for biotech professionals as well. First, can you tell us more about Biotility in general?

Tammy Mandell: Absolutely. Biotility was established by the state of Florida back in 2005, and we were developed as an arm or a center within the state focused on building workforce talent for the bioscience industries. This was a time when Florida had invested heavily in growing the bioscience industry as a new economic driver, and of course to support the growth of the industry, we need the workforce talent to fill these positions. The way that we approached developing workforce talent was really from three different angles. One is we developed and continue to develop certificate short courses that are designed to meet not only the current but the emerging industry needs. And this was done from multiple focus group sessions with the industry asking, “What do you find lacking in hiring your current new hires and even in your existing talent pool?” And then we worked to develop courses to address those gaps.

Our other approach was working with educators because if we’re going to build the talent pipeline, we need to not only embed the idea of working in these different roles into our curricula, but we also need to educate our students on, what are the competencies and skills you need to be successful in these roles? We offer a lot of educator professional development that really help them teach science in the context of industry careers, and like I mentioned previously, understanding how to integrate the idea of regulatory compliance and FDA oversight into the work that we do. And then the third prong is credentialing or workforce credentialing and what this is the mechanism to validate competencies and skills valued by the industry, and then they provide the credential earner an opportunity to demonstrate to potential employers that they have indeed mastered these competencies and skills.

Daniel Smith: Now, to get a little more specific on that three-pronged approach, can you tell us more about who these offerings are geared towards and what topics they cover?

Tammy Mandell: Because we are trying to not only build a pipeline of talent but address current needs with the industry, the individuals that take our courses are actually coming from very diverse backgrounds. Some of our courses were really designed for direct industry training so that people that are currently employed can advance in their position or possibly they just need to do annual training of some of the critical skills that are being looked at by the FDA. For example, good manufacturing practices is a course that not only is highly valuable to anybody who wants to become employed in the industry, but people that are already working in the industry are required to take a refresher course annually to be compliant with FDA training regulations. We also get a lot of undergraduates, graduate students and postdocs who maybe hadn’t initially thought they were going to go to work in the industry, but then realize that this probably was the most opportune path forward for them.

And they can take a number of our courses that really help fill the gaps that they didn’t get in their traditional bachelor’s degree programs or even graduate degree programs. Some of the more common courses that we have students take are the good manufacturing practices course. We have one about good documentation practices because documentation is such a critical skill within the industry. We have some that are more focused on lean practices and working efficiently and efficient ways of organizing an industry. We have some that are very industry specific, such as corrective action, preventive action, root cause analysis, so it really depends where they are in their career and where they are in terms of what they might already know or have experienced.

Daniel Smith: That’s wonderful. It sounds like there’s a lot of really helpful resources for people throughout different career stages. Can you talk a bit more about where and how people can access these courses?

Tammy Mandell: Like I previously mentioned, we really were established in the state of Florida but we now operate nationally. Most of our certificate short courses are available on the CITI Program on their platform. And this really opens the door for people to make use of these resources no matter where they are. In addition, our credentialing exam is offered nationally. We have over 250 test sites throughout the country. And the opportunity to earn the credential, whether at a test site or even remotely, is possible for anybody.

Daniel Smith: Absolutely. And again, I will certainly include resources in our show notes where people can learn more about where they can access these courses and how. Now, you just mentioned the credentialing exam, so I want to talk some more about that. Can you start by just giving us a brief overview of what the BACE is?

Tammy Mandell: The BACE is a national industry recognized exam that assesses core competencies and skills that were identified by the industry as valuable when they’re hiring candidates. And it’s the outcome of what we call a industry de cum analysis. And this is a process by which you really tease from people who are working in these specific roles, what are the minimum competencies and skills that are required to be successful in your job? And from that, we created a framework of the knowledge and skills and abilities that really needed to be in place, and it is now overseen by a national advisory board.

They maintain the framework of the exam. They actually do a thorough review every three years to make sure that it remains relevant to their needs. The national board also approves the version of the exam every year. We are an ISO 17024 compliant credentialing body, and as such, it’s a controlled exam. And again, we need to put out new versions, actually three versions of the exam each year to allow for retake. But at the end of the day, for somebody who passes this exam and it is a rigorous exam, it’s a comprehensive exam that’s made up of both a knowledge as well as a practical component, it’s valued by industry and in some cases as used as a preferred hiring qualification and certainly helps get a foot in the door and move on to employment.

Daniel Smith: Excellent. Who’s eligible for the BACE?

Tammy Mandell: We don’t set any criteria for eligibility. People can sit for the exam having learned these competencies and skills, whether from life experience or from participating in a specific program, so we don’t dictate that. I will say that those that are most successful on the exam are students who have either completed a rigorous high school program, although it’s a challenging exam and the pass rate at that level is about 50%.

A lot of students that are participating in the two-year degree programs and even the four-year degree programs. And for them, the pass rate is more in the range of 70%. The difficulty level of the exam is set by our advisory board. Again, keeping in mind that they are hiring people who are going to be working on manufacturing products that will impact a human life. They need to set the bar high, and you have to score an 80% to earn the credential. You do have the opportunity for retakes, but typically there’s some preparation that is involved. I will also note that Bio-Rad, which is an international company that provides materials and equipment and reagent supplies for the bioscience industries, also has an education and training arm called the Explorer Program, and they have a textbook that they aligned to the BACE, so it makes a really great resource for really anybody who wants to sit for this exam.

Daniel Smith: Can you provide some thoughts on what the best pathway for preparing for the BACE is and then what competencies and skills people should focus on when preparing?

Tammy Mandell: Biotility, as the credentialing body, cannot teach directly to the exam. It’s really up to different organizations to prepare curricula and deliver curricula that is aligned with these industry standards. And we do offer courses that would certainly help with the exam. Most of them go into a bit more depth than what is required on the exam itself. I think the powerful combination is earning this credential and then also having certificates of completion for these different courses.

For example, good manufacturing practices, it’s going to go into more depth than what you need to pass the BACE exam, but if you understand GMPs when it comes to that portion of the exam, you’re going to pass that portion with flying colors. Good documentation practices, same thing. More depth in the course. However, you combine that with the credential, and again, it’s going to really make a difference when you’re sitting for this exam. The BACE exam, the scope of the exam is broad because the idea behind it is that a company can hire a credential earner, and because they have this broad base of knowledge, they can now be very quickly trained on company specific protocols.

And this is really important to the companies. Again, as part of the regulatory compliance, they are going to have to conduct their own internal training regardless. But when you have somebody who already has the more specific knowledge regarding the technical skills in their applications or understanding the biological systems, how do we use cells and the cell infrastructure to manufacture a product? How do we purify our specific product away from that cell and that cell debris? How do we go about testing those products? What are the different assays that are used to ensure that our product is safe within a specific pH, meets the identity standards that we’ve set for it? These are all things that credential learners have under their belt. They also have basic safety. Again, that regulatory compliance piece and just again, an understanding of the science behind the techniques, because that’s what the industry said that they want is not just somebody who can do the work. They want them to understand why it’s done that way so that they can recognize when things are maybe trending out of compliance or aren’t working correctly.

Daniel Smith: For folks who do receive the BACE certification, are there certain requirements for maintaining the certification or are there just considerations for their own professional development over time?

Tammy Mandell: That’s a great question. The credential itself is valid for five years, and the hope is one of two things. If they sit for the exam after completing a high school program, more often and a not because it is such a rigorous exam, those credential learners are going to be continuing onto a post-secondary degree. The credential is still valid after they finish up their bachelor’s degree. If they haven’t found employment, then they would need to sit for the exam again if they wanted to have it as a credential to put forth to their potential employer. If they found a position, then they probably don’t need to sit for it again because now they’re on that trajectory for moving up.

Daniel Smith: Are there any additional resources where listeners can learn more about Biotility, BACE and just biotech careers in general? I know you already mentioned a few, but are there any others out there that you’d like to mention?

Tammy Mandell: Well, I’d highly recommend going to our website, the Biotility website that you can go straight to the BACE portion or just Biotility in general. If anybody registers to sit for the exam, whether through a school or simply as an individual, in which case they can do it remotely, they will have access to free practice exams, free study materials, as well as recommendations for other resources that they can use. I would also still encourage looking at the InnovATEBIO site and the biotechcareers.org site because there’s just a ton of information there. I think the first step really is just exploring the careers and seeing if it’s something that’s really of interest to you.

Daniel Smith: Absolutely. And those are a lot of very helpful resources. A lot for our listeners to check out. On that note, do you have any final thoughts that we’ve not already touched on today?

Tammy Mandell: One of the things that really excites me about the CITI Program and Biotility relationship is that we can really work together to explore different career paths and how we can create more content to really help individuals have opportunities and maybe careers that they really hadn’t thought of. And one thing that we’re doing now is going through the library of the CITI Program and the Biotility courses and looking at gaps that we might fill that could then lead to sequences or clusters of courses that could then be really synergized to create new credentialing opportunities. I think that there’s a lot of potential there. I think a lot of value to students that are participating in the CITI Program courses.

Daniel Smith: I agree. And I think that that is a wonderful place to leave our conversation for today. Thank you again, Tammy, and thank you to our audience for tuning in today. And with that, I look forward to bringing you all more conversations on all things tech ethics.