Volume 15, Number 4
Thirst for Knowledge and New Applications Drives Robin Dias
By Barbara Lewis
For Robin Dias, the road to ownership of Total Project Services has been paved with professional experiences that have exposed her to the myriad aspects of the biopharmaceutical world. She has become an expert in many of those areas and uses her broad knowledge to benefit her clients as they encounter the many challenges inherent in their industry.
Robin grew up in Livermore, the daughter of two educators. A high school microbiology class led her to that major at San Jose State University, while both her sisters became molecular biologists. “I loved peering into the microscope and was fascinated by the fact that microbiology is present is every aspect of our lives. Germs that cause disease are everywhere, of course, but bacteria also enable us to enjoy some of our favorite foods, like cheese, yogurt and wine. The endless opportunities for discovery go on from there.”
Robin’s first job after college was with the McCormick Company in Gilroy, working to reduce the bacterial load in products through laboratory work and by walking the fields of Kern County. After the company merged with a competitor, Robin left behind three years of “my hair smelling like garlic” and entered the pharmaceutical arena with Barnes Hind in Sunnyvale.
“I had learned so much at McCormick, from managing a Teamsters Union laboratory and learning about bargaining agreements to overseeing the merger of two competitors’ microbiology labs and functions,” Robin adds, “but pharmaceutical microbiology was a whole new world.”
At Barnes Hind, Robin went from agricultural products to sterile products and was introduced to drug regulatory requirements – everything it takes to have a product registered with the Food & Drug Administration (FDA). She was immersed in learning about all the aspects of critical controlled environments.
When the company moved to Phoenix, Robin declined the transfer and went to work at Syntex Laboratories, best known for pharmaceuticals such as Naprosyn, now marketed as Aleve. The company’s broad product line presented many opportunities to learn while conducting product research and development and working with quality control, veterinary products, and international regulatory requirements. “We set up new manufacturing areas and developed new product lines. The spectrum was so broad – liquids, creams, pills, injectables – the whole gamut. It was a great experience to be exposed to all of that.”
During this time, Robin was becoming more and more keenly aware of how directly microbiology is tied to the facilities where the work was being done and the regulatory submissions being made. She delved deeper into the “whys” of the FDA requirements and developed a deep understanding of the very valid reason behind all the grueling preparation -- the safety of the end user.”
From Syntex, Robin made another leap, into the biotechnology arena at Anergen, a maker of drugs to treat autoimmune diseases. “I was exposed to cell culture processes at Anergen. It was to work on the very beginnings of clinic trials. Being biotech, it was ‘small batch production’ where at Syntex it had been ‘mass production.’
“The actual process was very long, but I enjoyed working there because we were taking a research company to the next level, developing their quality systems and test methods. A small team of us procured all the equipment, designed our laboratories, wrote all the procedures and put them into place. We did all the necessary things to turn it into a real drug company, not simply a research operation. It was a great opportunity to learn.”
From Anergen, Robin went to Matrix Pharmaceuticals and the chance to broaden her experience further. Where Anergen had been moving from bench top research to small scale clinical focus, Matrix was going from clinical to commercial production. Opportunities existed to set up a GMP (Good Manufacturing Practice) operation and all related processes as well as to prepare for and undergo all required State, FDA and European inspections. “FDA approval for commercial use is a huge package to assemble. We sent our submission documentation away on pallets!
“We wore many hats in that job, but being on the front line for inspections and being part of the primary team was very exciting.”
When Matrix relocated to San Diego, Robin opted to stay in the Bay Area. “It was sad to see the company move, but also fascinating to learn how to close down a site,” she reflects. “The process of closing a manufacturing site entails many State health and safety regulations and is much more involved than one would suspect. In fact, a good proportion of our current work at Total Project Services is in the area of decommissioning buildings.”
Alza Corp., now owned by Johnson & Johnson, was Robin’s next professional move. The company was setting up its first aseptic site for production of an implantable drug-dispensing device. Robin was involved with the design of the site, from the gutting of the old facility to the designing and utilization of the new suites and laboratories. “We validated that whole system and got it going; a very rewarding experience,” she states.
In 1998, expecting her first child and wishing to work closer to home, Robin landed a position at the Clorox Research and Development Technical Center in Pleasanton. “Clorox presented a big change, from FDA to EPA (Environmental Protection Agency) regulations and pharmaceuticals to consumer products. I had the opportunity to work directly with the EPA in Washington, D.C. and collaborate with other industry partners. My role at Clorox was more that of a corporate ambassador rather than a subject matter expert and I enjoyed that very much.”
Robin and her husband, Michael Magnano, founded Total Project Services in 2002 and, in 2004, Robin left Clorox to lead their company full time. Here she was able to utilize the broad experience she’d gained throughout her career. “Michael had been involved in the construction project management side of the industry. The reality, as I mentioned earlier, is that microbiology and facilities are joined at the hip in our industry,” Robin explains. “For example, when the power goes down or there is an earthquake, the microbiologists are paged because they have to determine whether the facility and products were affected: Is the critical environment in a state of control? They are also charged with determining the action plan for getting the process back up and running.
“What sets us apart from other project management firms is that we come from inside the industry. Having started up many new laboratories and manufacturing suites, we can anticipate our clients’ needs and help them prioritize – which factors are critical and which can wait. We know that many tasks need to be completed simultaneously so that the manufacturing suites are actually ready for use on the targeted occupancy date. We know what questions to ask and we include the answers in the project plan.
“This planning stage is where all my varied past experience is most valuable. Michael and I can ask the end users the pertinent questions and fill in with our knowledge if they don’t have access to their own subject matter experts. For example, our current work with Macroflux in Fremont has us involved in many aspects of the project - site selection, scientific laboratories and environmental requirements. As with all our clients, we make sure that the building will actually be usable when it’s completed. We know how to make that happen because we’ve been there.”
Also in this issue ...
- Ross Stores to Expand Its Reach with dd’s Discounts
- USA Wu Chi Kung Fu Academy to Open New School in Park
- Business Bits
- Executive Profile: Thirst for Knowledge, New Applications Drives Robin Dias
- BHR Corp. Means Mental Health Services
- Post Office Keeps Pace with Electronic Age with New Self-Serve Kiosks
- Go Outside and Play!
- It Pays to Carpool: 511 Rideshare Kicks Off Rewards Program
- Amador Valley High and Special Olympics Team Up for Annual Sporting Events
- Valley Humane Society Finds Itself a New Home
- Hacienda Index