The kind of job Lisa Carter has is not one you can learn in school. You can learn engineering and science, of course, but to be the person who understands computer system compliance and quality assurance issues pertinent to the biotech sector takes practical experience.
And an invitation. Carter’s came in North Carolina in 1996, when she was working for engineering firm Fluor Daniel. The firm was building a pharmaceutical company in Raleigh, and Carter, right, was asked to work on a project. It was her first taste of an industry she had wanted to get into since she was 10, and one she built her academic career around getting to.
Carter’s road to her own business was not the traditional route. Though she founded and runs Team Validation, which ensures that biotechs meet federal regulations and industry-mandated guidelines, she did not slide over from a career at a pharma company.
Carter grew up in Pittsburgh to working-class parents. Her mother was a career U.S. Postal Service worker and her father was a quality control engineer for General Motors.
And while she says she had quality-assurance in her blood, she wanted to do something more than what was available to her. When she was 10 a few of her female cousins in high school relayed to her a call that was building at the time. The sciences, particularly engineering, were seeking more women. Particularly minority women.
Carter met her husband, Kevin (a writer and freelance contributor to U.S. 1) in Pittsburgh while she was working for Mellon Bank and he was a staff writer for the Pittsburgh Press (now Pittsburgh Post-Gazette) covering the arts and music. The couple moved to New Jersey when they got simultaneous offers to work in Philadelphia — she at Mellon Bank and he at the Inquirer.
The Carters settled in New Jersey and Lisa attended Camden County College, where she got an associate’s degree in engineering. She designed an internship program that took her to Hawaii, where she worked with an agency that supplied computer systems to special needs clients.
“I had never done work like that before,” she says, “but the director suggested that I stay in that line of work. So I did.”
She next landed a temp job at Fluor Daniel, and from there returned to New Jersey where she worked on the manufacturing floor of a biotech company before moving into computer system validation — the practice of making sure everything works as it should. An experience boom came with Y2K.
“Companies needed to test out their systems,” Carter says. “It was extremely easy for me to find work.”
By 2004 Carter was ensconced in the industry for nearly a decade, doing her own consulting work with the numerous pharma companies and biotechs in the Princeton area, and getting job offers.
“Just about every company I worked for offered me a permanent job,” she says. She had never been on the staff of a biotech, and when she came to the moment of truth, she realized she didn’t want to be.
“I made more money on my own than I would have made working for any one company,” she says. Besides, she had always wanted to start her own business anyway, so in 2004 she founded Team Validation in her home on Dorset Court in West Windsor.
Six years later, Carter has relocated her business to Independence Way, partly out of a need to expand, and partly to build more credibility with the Food & Drug Administration. The FDA has strict regulations about who can do what, and to get on the FDA's good side, Carter felt it was best to get a formal business address.
Some of what Carter has learned from the job, but not in school, centers around what the FDA demands. Biotechs are under tight control not just for what goes into a drug, but for the systems that surround it. The latest regulations, Carter says, concern security over computer systems that are used to develop a medical or biotech product.
“You don’t want to have anyone going in to tamper with the data,” Carter says. You need to have proper access codes and physical security measures — sometimes coming down to security guards keeping watch — because “you will get audited by the FDA eventually.” And the agency doesn’t take security and systems requirements lightly.
Carter’s firm ensures that data are safe and that there is an audit trail for the FDA to follow. All tests need to be validated, which is why her firm is named what it is.
Team Validation does mainly sub-contracting work for now, but Carter says she is pushing for more prime work. “When you go prime, that’s a big deal,” she says. So far the firm has done validation work for Bristol-Myers Squibb, Merck/Schering-Plough, Pfizer, and Johnson & Johnson.
Team Validation is now an FDA-certified company, and Carter often taps into government contract work under the provisions for minority and women-owned businesses.
Carter says the firm employs “fewer than 10,” but that exact numbers are tough to call. She is the president and her husband is vice president of communications, but project teams are built to what a job requires. “We follow the same model as most IT companies,” she says. “You don’t want to have a lot of people on the bench because then you have to cover the overhead.”
Team Validation LLC, 5 Independence Way, Suite 300, Princeton 08540; 609-514-5157; fax, 609-987-9499. Lisa Carter, president, CEO. www.teamvalidation.com.