
EDUARDO CONTRERAS / Union-Tribune
Leigh Amini's job includes making sure every step of a drug's development is properly documented.
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Leigh Amini
Position: Senior manager of regulatory affairs
Company: Althea Technologies
Age: 40
Career highlights: administration, Immune Response Corp.; manager of document control and quality assurance, Althea Technologies
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Leigh Amini had no intention of getting into the biotech industry. In fact, she was going to college to become a teacher when a job in administration led her down a different path.
She was working with Dr. Francoise Ferre, a leader in gene quantification and biomarker development with more than 15 years' experience in the field. Amini worked with him in an administration position at Immune Response Corp. and he brought her with him when he founded Althea Technologies in 1998.
“I started out doing everything,” Amini recalled, working in accounts receivable and information technology as well as in other capacities when the company was just starting. Over the past 10 years, she worked her way up to her present position as senior manager for regulatory affairs.
Her position involves document control between the Food and Drug Administration and Althea clients involving how drugs move through the FDA approval process.
Working with the company's quality assurance team, Amini ensures that every step of a drug's journey from discovery to the marketplace is properly documented. This includes manufacturing procedures, such as scale-up and process development, fermentation, purification, analytic testing, final formulation and product filling, in addition to making sure that each step follows correct practices.
Amini enjoys the fast-paced nature of the work as well as the interaction between clients and the 165 or so employees at Althea. She admits that some days feel “like there are not enough hours in a day.” But she also says she has accomplished more with her career in biotech than she thought possible.
Even though Amini never finished college or became a teacher, she is very satisfied with how her career turned out. She says that biotech is a great field with many career options, even for people who don't have a college degree.
“You should never rule anything out,” Amini said. “You have to give everything a chance in life.”