As a young executive recruiter thirty years ago, the most important thing for the growth of my business was my network. Bioprocessing roles were my domain at the time, and it was a great honor when BioPharm asked me to join their Editorial Advisory Board for a time. That select group of individuals would pave the way for dozens of friendships and business opportunities within the biomanufacturing space.

One of those key contacts was Dr. Howard Levine. For many years, Howard has been a highly visible and well-known consultant in biomanufacturing and CMC. But before his consulting company gained a reputation, Howard was a successful leader of biomanufacturing operations with four of the most important early biotech companies. Recently, Howard opted for retirement, and I met up with him to discuss his career choices and his advice for those coming up behind him now that he’s stepping aside.

DGJ: Howard, you started your career as a chemist, but rapidly put your stamp on the biology field, for companies like Genentech, Amgen, Xoma and Repligen. I was surprised when you told me that you had actually started as a chemist in an academic post, as I always thought you were an engineer.

Howard Levine: You’re not the only one, Dave, who thinks of me as an engineer. When I started college, I was an engineering major. But I found it a bit boring and it seemed to me that engineers made too many assumptions. So, I switched to chemistry. A lot of people thought of me as a bioprocess engineer, and in fact I became the President of an AIChE chapter for a year. My answer is that yes, I am a chemist, but I can hold my own with the engineers. That transition to industry came originally because protein chemistry skills looked to be an important skillset.

DGJ: Tell me about that move you made from chemistry in an academic setting to playing a role at what many would consider the birth of a new industry?

Howard Levine: I was doing my postdoc at Harvard, in Frank Westheimer’s lab. [Westheimer was a National Academy of Sciences chemist and a winner of the National Medal of Science.] In a lab like that, all the assumptions are that you will end up a Professor. But people started to talk to me about jobs in companies. At the time, I had an older brother who I saw struggling on the Professor ladder, working on grants and so on. It was about 1979 when one workmate told me, “I’ve got a friend who’s out at this new company called Genentech. I think they might be interested in someone like you,” and he wrote them about me. One thing led to another and I was offered a position on the West Coast in a department that was initially the protein research department. Genentech had less than 100 people in total at the time.

DGJ: Wow – today it is more than 13,000 people. I’d say you were in at the very start of that one! One thing I always admired about you, Howard, is that you weren’t afraid to listen to the occasional call from outside your organization. It would have been mighty easy to just stay at Genentech and put your career into cruise control, growing with the firm. But you didn’t do that. In fact, you made another big geographical move, this time from NorCal to SoCal.

Howard Levine: That’s right. After about four years at Genentech and some great experience in process development, I moved to Amgen, which was just setting up a production scaleup department. One of the key leaders from Genentech had left for Amgen and he recruited me and a few others to move South. There, I worked on their interferon project as well as bovine interferon. I was at Amgen when erythropoietin [EPO] was first cloned, and that’s what really put Amgen on the map. After some years there, I was recruited back to the Bay Area to work for Xoma. It was a cool job because Xoma was one of the first companies developing antibodies as commercial products.

DGJ: Didn’t the “antibodies as drugs” business begin with murine antibodies? I remember the huge impact that Xoma had with their work, and as I recall, it was all done in a gigantic mouse-ranching operation.

Howard Levine: Yes! We were making them in mice and in partnership with Charles River. It was my job to optimize the process of making antibodies in mice. As we moved up in scale and to production for clinical trials, we had to scale up to multiple thousands of mice per run. This is when I began to get more involved in manufacturing, as well as development.

DGJ: That must be where you really earned your stripes in process engineering, Howard, because when we met I know that you were considered the guy for questions about downstream processing and chromatographic or filtration processes for antibodies. That was the sharp edge of the sword for you for much of your career, am I right?

Howard Levine: Yes, this became a serious focus for me. I worked with partners at Millipore, for example, to develop the first nanofilters for virus removal. But I was sort of in a holding pattern for my career at the end of my stay at Xoma, as there were some clinical safety issues and the drugs weren’t approved. As luck would have it, I got a call one day from a recruiter for a role of VP Manufacturing Operations at Repligen, and we picked up and made the move back East.

DGJ: To Boston, eh? From one hot bed of the new industry to another, and to a company that had been developing quickly as one of Boston’s prime examples of biotech. They even had a large biomanufacturing effort under way which you took over at the time.

Howard Levine: That’s right, and along with manufacturing recombinant Protein A, my responsibilities also included supplying Repligen with clinical trial materials for a number of their drugs. But in late 1993 or early 1994 there were a couple of setbacks, and it was difficult to find the cash we needed. The industry was in bad shape, as there hadn’t been a lot of biotech approvals and it had begun to look like a sinkhole to investors. I had built up this terrific team of more than 100 scientists and engineers, and then had to go through the painful process of laying off most of them. I left myself in 1994 during this first restructuring of Repligen.

DGJ: And this must be where you transitioned once again, this time to the independent consultant role. For many, that’s a short-term gig that fades in comparison to a job working fulltime with a given product and team. But you went a different route and used that role as a kick-starter to build a bigger business.

Howard Levine: I found that I really enjoyed the consulting work. At that point, the summer of 1994, I founded BioProcess Technology Consultants. I worked initially as a sole practitioner, but as the industry grew and the demand for contract services grew, I found that I was getting way too much work. I hired a total of 30 consultants, all with experience in CMC. We built that company and had clients all over the world and then in 2019 we were approached by BDO as they were interested in adding these services. [BDO is a top ten global services provider]. The company name was changed to BioProcess Technology Group and I stayed on for a few years to ensure its successful integration into BDO.

DGJ: How would you advise a younger scientist or engineer who wants to grow like you did into a leadership role in today’s biotech.  Are there lessons you learned early on for leading others in product development and scaleup?

Howard Levine: Like you say, I was moved into management at a fast paced and turbulent time in the industry. I never had any formal management training. These days there is more of a recognition that management is not just something that comes naturally to people. It’s hard to just grow into it. My suggestion is that readers need to add this skill via whatever training their company offers, as most of them want to support the development of young leaders.
Hopefully, you have a good boss and you can watch and learn from that person. Watch for her listening skills, as that is so important. Is the boss able to offer advice and guidance without being overbearing and without micromanaging? My philosophy has always been to give my reports the overall guidance of where they should be going; a roadmap on how to get there. But then, a good manager needs to get out of their way and just let them do it.
The better managers want to hire someone who is better than they are in the given area. That’s the kind of team you want to build—it’s good for their career and yours. One lesson you need to learn is how to be “hands off” as much as possible but still be seen as available. You need to recognize when they need you, when they are struggling, and be open to listen and support them.

DGJ: What do you think might be the biggest challenge for these new industry scientists and engineers?

Howard Levine: As graduate students, you are trained to work for yourself, and your mentors and Professors are working for themselves as well. So, you come from this mindset and you get thrown into industry where you end up being a part of a team. That’s just such a unique experience! You can’t understate how critical it is to persist through that transition. People struggle with it.

DGJ: Did you struggle with technology differences as well in industry, or was that not a big deal?

Howard Levine: One of the things that was attractive to me is that it was a young industry in transition, because I like change and new ideas, innovations. But it’s still like that. Sure, it is not a “young” industry any longer, but everything is still in transition. There’s always something new coming down the road, so my advice is to be flexible. Don’t label yourself an “antibody person” because next year you could be working with some new mRNA vaccine, or a cell therapy product. But that’s what is so cool about the industry, There’s always something new coming along. So, I would say to be flexible. Don’t label yourself. You’re going to need to be learning, to shift as the industry changes, and there will always be plenty of that.