Tech update
OPPORTUNITIES AT PHARMA AND BIOTECH FIRMS

Qualified techies are in demand at pharma & biotech companies

The firms "want people who can immediately add value and make an impact," says an industry watcher. Some engineers have segued into science-related work

By Emily R. Blumenfeld
Contributing Editor

Jose Ramirez is a VP of IT at Novartis, supporting finance and supply chain.

At MedImmune, ChE Kristan Latham is QA manager for Synagis, a flagship product.

'We saw a four-fold increase in demand for highly qualified individuals beginning in the first half of 2004," reports Jacquie Klein. She is senior partner for pharmaceuticals, medical devices and biotechnology at Lucas Group (Dallas, TX). In partnership with the Wall Street Journal, Lucas is a major recruitment firm, with corporate HQ in Atlanta, GA and twelve locations around the country.

There's a true shortage of highly qualified technical talent, Klein believes. Companies "want people who can immediately add value and make an impact, particularly in lean manufacturing and continuous improvement," she says.

Klein sees a strong demand for experienced manufacturing, process and quality engineers. There's a special interest in quality engineers who specialize in supplier audits, an area that impacts the entire manufacturing process.

With the increased scrutiny of the industry by the Food and Drug Admin (FDA), Klein foresees a continuing strong demand for people with backgrounds in quality or regulatory affairs, quality control and a variety of other quality-related areas.

She is also looking for people experienced in corrective action/preventive action (CAPA) or chemistry manufacturing control (CMC), for Six Sigma black or green belts, and for candidates who are ASQ (American Society for Quality) certified and have worked in a good manufacturing practices (GMP) or ISO environment. These, says Klein, are what distinguish one resume from another.

The well-positioned pharma or biotech candidate, she says, has spent five to ten years in manufacturing, preferably all at one good company, has a good educational record and an excellent work history. She notes that an MBA plus a BS in engineering "positions someone very well for advancement."

The BS/MBA is the optimum educational mix for a prospective manufacturing ops manager or VP. On the other hand, an advanced degree that focuses on biol-ogy or chemistry is good "if you know you want to be in quality control or R&D.

"I encourage all candidates to consider the field," Klein says. "I think the world is wide open for them, and I'm always looking for candidates with good credentials."

Diversity at Novartis

Laurie Pellegrino

Laurie Pellegrino is executive director for organizational diversity at Novartis Pharmaceuticals (East Hanover, NJ). At Novartis, "Understanding and utilizing the power of diversity is a core value and a prized element of our corporate culture," she notes.

A diverse workforce is considered a competitive advantage at Novartis. "Diversity drives innovation and creativity, and is a critical success factor for pharmaceuticals," Pellegrino says. "A company with a workforce that reflects the diversity of its customer base is more likely to understand and meet the needs of its customers."

Pellegrino notes that IT is "a significant enabler of our business success. From drug discovery and development to marketing and sales, we expect IT to work cross-functionally across the organization." Strong project management skills and an understanding of business needs are useful adjuncts for the IT star in pharma and biotech, she declares.

Jose Ramirez: Novartis VP in IT and more

Jose Ramirez

Jose Ramirez has been a VP of IT, supporting finance and supply chain at Novartis since 2002.

Ramirez grew up in San Antonio, TX where his dad worked in civil service. In 1972 he graduated from St. Mary's University (San Antonio, TX) with a major in English and a minor in CS. He completed an MBA at Southern Methodist University (Dallas, TX) years later, in 1990.

After he finished his bachelors Ramirez found a job doing general office work at a sheet music company. One day the president called him in and said, "Our IBM operator quit. Do you want the job?"

"I jumped at the opportunity," Ramirez says. "Punching and sorting cards on antiquated equipment is how I got into IT, and I've loved technology ever since."

He spent some years honing his craft at an IT service bureau. In 1981 he joined Sandoz Animal Health (Dallas, TX), where he became IT director and eventually CFO.

In 1993 Sandoz consolidated animal health into its crop business, and Ramirez moved to Chicago to continue his career. Then in 1997 Sandoz merged with Ciba to become Novartis.

Ramirez saw great opportunity in Novartis' pharma division. "The pharmaceutical business has always been a big attraction for me. I realized it was the flagship of the new company, the most strategic part of the business and certainly where the biggest challenges and the biggest rewards could be."

Ramirez came to the pharmaceutical industry very familiar with the process of regulatory compliance. "Even though I had not had much experience with the FDA, both the animal health and the crop businesses were closely regulated by the EPA," he explains.

His experience in finance, manufacturing and other parts of the business has been especially useful in "building strong relationships with my business partners in the company. I can speak to them in business terms and talk about developing the new types of IT services they need to drive business value.

"The work we do in information systems development and deployment helps the business accomplish its mission of serving doctors and patients. We're saving lives with the work we do," he says.

"When people come to work at a pharmaceutical company, they know what's on the line. The quality of their work has to be of high caliber because of what's at stake. I think that's very motivating."

ChE Kristan Latham is QA manager at MedImmune

Kristan Latham

Although her father was an ME, Kristan Latham's family lived on a farm in Ohio. The life sciences, she says, were always part of her daily life. So when she went on to study for her 1991 BSChE at Ohio State University, she made sure to take biochem engineering and microbiology classes.

The summer after graduation she did an internship at Amgen (Thousand Oaks, CA). This solidified her desire to work in the biotech field.

In grad school she added electives in immunology, cell biology, molecular biology and bioengineering. She received her MSChE from the University of California-San Diego in 1993, and started work at MedImmune in Gaithersburg, MD, which is now the company's corporate HQ.

Latham has been at MedImmune for eleven years. The company was founded just sixteen years ago. As she "grew with the company," she says, her whole career focused on Synagis, MedImmune's flagship product for infants at high risk for respiratory syncytial virus.

For her first six years she worked in Gaithersburg on all phases of the drug's development, from its earliest stages through commercial production. In 1999 Latham moved to the Frederick, MD facility where Synagis is now manufactured. She was the cell-culture specialist in QA, following the code of federal regulations from the FDA.

For the past three years, she notes, QA has been "on the floor." That means that QA staff review the batch records in real time as the product is being manufactured. "We're what I would call an objective pair of eyes," she says.

Latham has been QA manager since 2003. "It helps to be detail-oriented," she says, and able to analyze the situation. For example, she uses root cause analysis "to correct any issues that come up and prevent any that we can." As an engineer, she says she's "trained to look at problems a certain way, and I think that comes in very handy as well."

Clearly, making sure they get a quality product out the door is critical. "Our product is going to help premature infants. I think that's what makes the work so rewarding."

ChE Dr Nilesh Ron manages processes at Stryker

Dr Nilesh Ron

Dr Nilesh Ron is manager of protein formulation development at Stryker Biotech (Hopkinton, MA). He also manages product/process development and optimization and engineering scale-up. He joined the company as a research scientist in 2000.

Ron received his BSChE in 1994 from the Indian Institute of Technology (Bombay, India) and his PhD in ChE in 1998 from Washington University (St. Louis, MO). His interest in the pharma and biotech industry grew from work on his PhD thesis, on engineering modeling of sustained release polymers and oral drug uptake by the human body.

He sees ChE as an excellent background for working with drugs and medicines. "It provides a broad education in fluid and solid transport mechanics and the fundamentals to apply your knowledge to any field," he explains.

As he works he's continuing to learn about protein chemistry, biochem and the biophysical characterization of proteins. "Each protein has an individual identity, and the process of discovering the mysteries of biomolecules can be energizing," he says. He still calls on his ChE background, and applying it to the medical field "gives me the satisfaction that I'm using my knowledge to help people."

Interacting with manufacturing, quality control, QA and regulatory departments, he says, "makes you appreciate how many different facets go into making a drug. People are shocked when I tell them it takes ten to fifteen years to develop a drug and successfully commercialize it, but when you're in this field, you realize how complex the task really is."

Ron is currently pursuing his MBA at Clark University (Worcester, MA). "It's helping me get a well-rounded understanding of the whole business process, including how R&D is used to sustain a profitable business and at the same time help people."

ME Saurabh Phansalkar is a project engineer at Stryker

Saurabh Phansalkar

Saurabh Phansalkar came to the U.S. in 1999 with a BSME from the Government College of Engineering (Pune, India). He received his MSME from the University of Toledo, OH in 2001 and his MS in engineering management from Dartmouth College (Hanover, NH) in 2004.

Phansalkar initially wanted to work in R&D. But as a grad student at U Toledo he had a job as a research associate on a project with General Motors, and that, he says, is when he started to rethink his goals. "I found I need something more hands-on and where I have more interaction with people."

When he got to Dartmouth's engineering school, he was introduced in-depth to biotech and pharma. He recognized an exciting opportunity to work with "the latest cutting-edge technology that will be used for medicines that benefit mankind."

So after graduating from Dartmouth, Phansalkar found a job at Stryker Biotech's manufacturing facility in West Lebanon, NH. He's called a process engineer, but "Right now I'm acting more as a project engineer on the process side," he says. He's working on a capital expansion. "It's a huge project and I'm really excited about it," he says.

Part of the expansion project involves moving a manufacturing operation from Stryker's Hopkinton, MA HQ to the New Hampshire facility. "My role is essentially studying and simulating the process here, with help from consultants and other departments," he explains.

He assesses the needs from a process standpoint. "That includes everything from scheduling to detail design of the new equipment, room layouts and utilities needed for the equipment and areas that I'm responsible for."

Phansalkar sees his work at Stryker as "an opportunity to learn, experience and contribute to the field.

"Most companies go through this type of capital expansion only a few times in their lifetimes. I'm learning how you develop a plant, starting from zero, building everything from the ground up. It's an exciting opportunity."

D/C  

Emily R. Blumenfeld is a freelance writer located in north-central New Jersey.

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