Lois Vidaver

 

 

THE UP AND COMING FIELD OF BIOTECH/BIOMED ENGINEERING IS EXPERIENCING A GROWTH SPURT

 

ACCORDING TO THE BUREAU OF LABOR STATISTICS (BLS), JOB GROWTH FOR BIOMEDICAL ENGINEERS (THE BLS DOESN’T SEPARATE OUT BIOTECHNOLOGY ENGINEERS AS A SUBGROUP) IS PROJECTED TO GROW 27 PERCENT FROM 2012 TO 2022, MUCH FASTER THAN THE AVERAGE FOR ALL OCCUPATIONS.

 

BIOMEDICAL ENGINEERS ANALYZE AND DESIGN SOLUTIONS TO CHALLENGES IN BIOLOGY AND MEDICINE WITH THE GOAL OF IMPROVING THE QUALITY AND EFFECTIVENESS OF PATIENT CARE. THEY TYPICALLY NEED A BACHELOR’S DEGREE IN BIOMEDICAL ENGINEERING FROM AN ACCREDITED PROGRAM TO ENTER THE OCCUPATION. ALTERNATIVELY, THEY CAN GET A BACHELOR’S DEGREE IN A DIFFERENT FIELD OF ENGINEERING AND THEN EITHER GET A GRADUATE DEGREE IN BIOMEDICAL ENGINEERING OR OBTAIN ON-THE-JOB TRAINING IN THE FIELD. FOR MORE INFORMATION, VIEW THE BLS WEBSITE: WWW.BLS.GOV/OOH/ARCHITECTURE- AND-ENGINEERING/BIC.

 

THE FIVE PROFESSIONALS FEATURED IN THIS ARTICLE HAVE TRAVELED SEVERAL OF THOSE CAREER PATHS, LANDING IN CORPORATIONS THAT ARE GLOBAL HEALTHCARE LEADERS, TO PERFORM WORK THAT HELPS PATIENTS PROLONG OR ENHANCE THEIR LIVES.

 

ACHIEVING RESULTS AT CSL BEHRING

CSL Behring is a global biotherapeutics company committed to saving lives and improving the quality of life for people with rare and serious diseases worldwide.

 

Danielle Trantham works with the various manufacturing areas to identify potential process improvement projects. When opportunities are identified, she provides project management support to implement those projects within the manufacturing processes. “We collaborate and work together to achieve better results for the patients who rely on our therapies,” she says.

 

Growing up, Trantham knew she wanted to be some sort of scientist.

 

“I had this vision of myself in a lab mixing chemicals and conducting experiments,” she recalls. “In high school I was exposed to engineering, and I knew right away that chemical engineering was the field for me. What I didn’t know at the time was the vast number of career paths that are available.”

 

During career day on her college campus, Trantham had the chance to meet with representatives from different industries including paper, chemical, petroleum, and pharmaceutical. Drawn to pharmaceuticals, she earned a bachelor’s of science degree in chemical engineering from Louisiana Tech University.

 

“I wanted the result of my work to impact lives and help others in a positive way,” she says. “There is no better satisfaction than knowing that the products we produce improve quality of life and save lives. Everyone at CSL Behring is passionate about meeting the needs of patients worldwide.”

 

At the beginning of her career, responsible for the validation of new production equipment and new products, Trantham enjoyed learning the manufacturing processes and how the equipment operates. Trained in project management and lean manufacturing, she has applied that knowledge when managing different types of projects and leading the implementation of process improvements.

 

Her most satisfying project so far featured work on CSL Behring’s new plasma pooling machine, used to pool bottles of frozen plasma. The plasma is collected at CSL Plasma, a subsidiary of CSL Behring that operates one of the largest plasma collection networks in the world. Serving as project manager, Trantham was involved with the design, installation, and validation of the machine, which uses two robots to pick up bottles of frozen plasma, insert them into a cutting machine to remove the top, and then release the plasma into thaw tanks.

 

“The best part was learning how to program and operate the robots,” states Trantham. “Most important, the new plasma pooling machine was a true process enhancement, and at CSL Behring we continually innovate and seek better ways of doing things. One thing that has surprised me most about the industry is the number of medical products that can be manufactured from a single liter of human plasma.”

 

CSL Behring is focused on continuously improving its manufacturing processes and creating operational efficiencies, Trantham points out. “In order to comply with new regulations, our company spends a good amount of effort in identifying and implementing new technologies and automation within the manufacturing processes,” she adds. “We strive to be the best at what we do.

 

“I recently became a mother to a beautiful baby girl, Samantha,” Trantham adds. “I want to be a role model for her, and show her that you can have a dream and achieve it with determined focus and a lot of hard work.”

 

FINDING FULFILLMENT AT NOVO NORDISK

The Novo Nordisk mission is to develop and produce high quality insulin products for diabetic patients in order to improve their quality of life.

 

As product development engineer—quality assurance aseptic production, Melissa Hester develops insulin production processes at the company’s U.S. site in Clayton, NC. “Using insulin formulation instructions developed at our headquarters in Denmark, part of my job is to transfer those processes to Clayton and integrate them into our systems and production lines,” she explains. “I am also responsible for reviewing and approving critical documentation, investigations, and procedures to ensure site compliance with federal regulations.”

 

Hester earned a bachelor’s of science degree in materials science engineering from North Carolina State University, after deciding that a career that involved developing products for patients that help maintain and improve their everyday lives would be fulfilling.

 

To best prepare for a career in pharmaceuticals, Hester advises, it is helpful to have some knowledge of the FDA regulations before starting the job. Pharmaceutical manufacturing is strictly regulated, and understanding how those rules and regulations apply in a manufacturing environment would help someone transitioning into a pharmaceutical career. It is also important to have a good understanding of cGMP (current Good Manufacturing Practices), FDA guidelines and regulations, as well as problem-solving skills.

 

“What I like most about working for Novo Nordisk is being a part of a company that provides life-saving products to people. When you leave work every day, you know that you have done something to help a person’s life and make it a little easier for them,” Hester says.

 

DELIVERING INNOVATION AT BRISTOL-MEYERS SQUIBB

The mission of Bristol- Meyers Squibb (BMS) is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.

 

Angela Y. Au, PhD, Engineer II, began in biologics process development when she first joined BMS, becoming part of the Biologics Drug Substance Upstream Manufacturing Sciences and Technology organization in December 2013. She has worked on several early and late stage pipeline antibodies and fusion proteins and currently works on the Nulojix cell culture process.

 

Nulojix is an approved biopharmaceutical that is used to prevent acute rejection in adult kidney transplant patients. Her responsibilities include supporting commercial manufacturing campaigns by working with operations and leading laboratory studies related to process improvements and investigations. She also works to improve the upstream small-scale models use in the labs. “I also support next generation cell culture processes in collaboration with process development, write reports supporting regulatory filings with Health Authorities such as the FDA, and help with health authority inspections,” she states.

 

Biomedical engineering (BME) is a natural fit for Au, tying together her passion for science and math with the ability to help people in the field of health sciences. Researching the BME field while in high school, she recognized that it encompasses the various engineering disciplines. “It seemed like BME would keep me challenged as the field is constantly evolving,” says Au. “The idea of developing methods and solutions to help enhance a patient’s way of life or longevity was my main driver for choosing this particular career path.”

 

Au earned her bachelor’s in science degree in biomedical engineering in 2003 from Johns Hopkins University, pursuing a second major in mathematical science while minoring in entrepreneurship and management. She followed up with a master’s of science degree in bioengineering from Syracuse University in 2005. Continuing part-time at the university toward a PhD in biomedical engineering, she worked full-time in the nutraceutical industry as research and development manager. Au completed her PhD in 2011.

 

She points to her mentors as a vital ingredient to her success. At Johns Hopkins, Au reached out to Dr. Carmelita Frondoza, who served as her undergraduate research advisor. “Dr. Frondoza became my mentor and served as a role model for women in engineering and medicine, balancing her family and work life, while being one of the reputed leaders in the field dominated by males,” Au remarks.

 

Well after earning her undergraduate degree, Frondoza continues to inspire Au, to improve herself by learning how to communicate effectively, think on her feet, and challenge herself as well as the status quo.

 

“Dr. Frondoza constantly enforced the idea that as a female engineer and scientist, it was important that I be able to support myself through my accomplishments, through publications, by sharing my research at conferences, and to create a network of colleagues by serving on various committees and reviewing peerreviewed manuscripts,” says Au.

 

Dr. Julie Hasenwinkel, Au’s graduate school advisor, also served as mentor. “These strong, intelligent women role models have both shown me, and others, that women can be successful, respected engineers and scientists while also balancing personal lives,” says Au.

 

Once on the job, she found inspiration at BMS. “As a new hire, BMS was helpful by providing a culture that supports existing and new employees,” Au comments. “BMS spans several locations and sites around the world, and this requires close collaboration with colleagues across the network. Additionally, BMS is highly engaged in its employees’ personal development, which allows continued growth within the organization and also career-wise.”

 

Au’s advice to young professionals or recent graduates is to ensure a basic understanding and grasp of the fundamentals with respect to that chosen career. “Things are most likely not going to go as planned, but the flexibility to adapt to change is crucial,” she says.

 

“Being able to adjust to roadblocks or deviations has ironically been why I am where I am today,” Au continues. “I never set out to work in the nutraceutical industry nor the biopharmaceutical industry at Bristol- Myers Squibb. Based on my undergraduate and graduate school research which I loved, I thought I would be at a biotechnology company designing polymeric scaffolds for cartilage repair, nanoparticles for spinal cord repair, or developing an artificial liver model. However, despite straying from biomaterials research and what I had initially set out to focus on, the fact that I am able to help patients by providing them medicines to prolong or enhance their lives is what drives and motivates me daily. I really love what I do. I continue to gain new skills daily and am constantly being challenged to find solutions to problems.”

 

SOLVING PATIENTS’ NEEDS AT ELI LILLY AND COMPANY

Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world.

 

Sarah Langan is as - sociate consultant engineer in the bioprocess research and development organization. Specifically, her role is to produce new medicines for clinical trials, and to determine how to scale up a laboratory-scale process to a large-scale manufacturing process to produce medicine for human use. These new medicines span a wide range of therapeutics, such as treatments for diabetes, cancer, and Alzheimer’s. “It is personally rewarding to be part of a team that helps solve unmet patient needs,” Langan says.

 

Langan graduated from Rose-Hulman Institute of Technology in 2006 with a degree in chemical engineering. While at Lilly, she completed a master’s in engineering from Purdue University in 2013.

 

Math and science were favorite subjects at school, and interesting courses at Rose-Hulman and handson summer internships helped confirm engineering was a good fit. “I really enjoy that I get to use math and science to solve problems,” Langan says.

 

Enjoying the people she works with, Langan especially values the knowledge and ideas each of those individuals brings to the company. “Everyone plays an important role, from scientists to equipment operators. It’s fun to work in an environment where everybody is on the same team,” she says.

 

Exploring all options is instrumental when preparing for careers like Langan’s; she shares that she rarely says “no” to an opportunity. “There is always something to be learned from exposure to new situations, and those experiences help fine-tune career choices and work advancement,” Langan says. “Even if a task isn’t particularly enjoyable or rewarding, it’s still a very important guidance tool. For the most part, my college and work experiences have been wonderful, but it is the accumulation of all of them that have helped shape my career.”

 

The engineer also recognizes the importance of being involved in extracurricular activities. With her Lilly coworkers, she participates in community outreach events, and plays in an after-work volleyball league. “Professional societies like the Society of Women Engineers and International Society for Pharmaceutical Engineering have broadened my network outside of Lilly,” notes Langan. “Besides being fun, these activities can often be differentiators when applying for a job in college, or advancing your career.

 

“I think the most important skills to be successful in any role are to be hard working, inquisitive, and kind,” she adds. “It also doesn’t hurt to be well organized. It is easy to feel overwhelmed by a complex problem or project. A well-organized approach usually makes any problem seem more manageable.”

 

RIDING THE WAVE OF THE FUTURE AT TEVA PHARMACEUTICAL

Teva is a leading global pharmaceutical company whose mission is to deliver high-quality healthcare to millions of patients every day. The company is dedicated to addressing unmet patient needs through the innovation and creativity that its integrated generics and specialty capabilities brings to the science of combining drug development capabilities, devices, services, and technologies in a holistic, patient-centric approach.

 

“At Teva my job is to create, build, and grow the personalized medicine & pharmacogenomics unit in a way that will ensure that Teva has the capabilities to integrate biomarker research, and treatment personalization, into our drug development programs – where there is a clear benefit for patients and healthcare in terms of a clinically meaningful improvement in benefit/risk profile.” says Iris Grossman, PhD, vice president, global head of personalized medicine & pharmacogenomics.

 

Grossman’s education includes Duke University, research associate, pharmacogenetics, 2005 –2007; Weizmann Institute of Science, PhD (collaboration), medicine/ pharmacogenetics, 2002 – 2005; and Technion - Israel Institute of Technology, Direct PhD, medicine/pharmacogenetics, 2000 – 2005.

 

Originally, Grossman wanted to be a neurologist, “to work with patients and help people feel better.” However, while pursuing her PhD, she got a “wake-up call to the impact our genetic make-up has on the way we respond to drugs, and how solutions could potentially be engineered around it,” Grossman recalls. “This was my calling. It became clear to me that this was how I could follow my dream of helping people feel better but in much more fundamental way and on a much bigger scale.”

 

The issue, Grossman believes, is that following the more typical “one size fits all approach” to medicine is quite limited. “We all know that each of us is unique and this approach is not exactly efficient,” she says.

 

Grossman’s been fortunate to have been an interal part of projects that “had the effect of impacting mindset and strategy across multiple large pharmaceutical companies – this in itself is enormously rewarding and satisfying,” she acknowledges.

 

The one project that stands out involves developing a genetic predictive test for response to Copaxone, a well-known treatment for patients with multiple sclerosis.

 

“This has been a complex and challenging project; however, if we can successfully identify those patients who are genetically predisposed to show a high response to Copaxone, we would hope to provide those patients with a vastly superior benefit risk profile- potentially making a huge impact on the success of their treatment and on their lives,” she explains.

 

The biomedical industry has shown a great openness and willingness to allow compelling science to change the traditional way of developing drugs, she says, feeding a significant increase in investment and leading to a greater number and broader spectrum of development programs that move faster to the market.

 

“The willingness of the industry to adopt personalized medicine and pharmacogenomic techniques provides the platform for the future direction of the industry,” says Grossman. “I can only see even greater investment, further advances in understanding and application, and, subsequently, even broader outputs and therapies that cover additional diseases and larger patient populations.”

 

Grossman finds this booming area of activity incredibly satisfying. “More and more of this field allows you to link science to meaningful therapeutic solutions and to see the entire process within a reasonable time frame,” she says. “This is exciting and compelling and provides momentum for research in the field that will ensure its continued vibrancy and evolution for a long time to come.”