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August 15, 2011
Volume 89, Number 33
pp. 40 - 43

Quality Prospects

Drug developers are bolstering their quality management teams in response to a more rigorous regulatory climate

Susan J. Ainsworth

Andrew McLaughlin/Eli Lilly
Critical Vargas checks a sample of insulin at Lilly’s parenteral manufacturing site in Indianapolis.
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After waves of massive layoffs prompted in large part by the Great Recession, companies involved in drug development have been operating with bone-lean staffs over the past few years. However, drug and biotech companies have been cautious about drastically cutting staff from one area of their business—that which involves quality control and quality assurance. And now, as the regulatory environment grows increasingly global and complex, companies are reevaluating the strength of their QC and QA ranks.

While some companies are simply maintaining their staffing levels in these areas, others are recruiting a modest number of QC scientists, who primarily test samples of drug ingredients and drug products to verify quality and effectiveness, and QA experts, who focus on conducting internal and external audits and reviewing all testing and manufacturing documents to be sure that they meet regulatory guidelines.

These new hires don’t just help drug and biotech companies remain compliant. They also help companies monitor the increasing volume of drug ingredients outsourced from developing countries and leverage state-of-the art analytical techniques to help speed safe products to market.

“Recently, we have been called in to do a lot more work on hiring into the quality departments of pharma and biotech companies,” says Daniel Gold, vice president for the research and development practice at Lynbrook, N.Y.-based Fairway Consulting Group, which provides global pharmaceutical, biotech, and medical device recruiting services.

“We have been filling some really exciting middle- to senior-level jobs for emerging and well-established companies,” he says. For example, Fairway has been helping small, emerging pharmaceutical companies find people to oversee the contract organizations that handle their manufacturing, he says.

“Today, there is a serious need for talented people in the quality functions, because companies have seen that any missteps in the manufacturing process can cause huge problems that can potentially cripple a pharmaceutical or biotech company,” Gold says.

“Once publicized in the media, quality lapses can stain a company’s reputation, which will ultimately lead to lost revenue.”

Niedre Heckman, who just joined Baxter Healthcare as a regulatory affairs manager at its Westlake Village, Calif., site, concurs. “Companies are increasingly sensitive to corporate social responsibility, and there is growing understanding that poor quality practices are very harmful,” says Heckman, who spent 11 years working in pharmaceutical quality at 3M before working briefly as a QA consultant. “Once publicized in the media, quality lapses can stain a company’s reputation, which will ultimately lead to lost revenue.”

Recently, numerous companies have suffered the consequences of quality deficiencies. For example, McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is still trying to restore its reputation after QC problems forced it to recall more than 40 types of widely used children’s medicines, including Tylenol, Sudafed, and Benadryl, in April 2010. In another case last year, GlaxoSmithKline pleaded guilty and paid $750 million to settle complaints that it knowingly marketed adulterated products made at a plant in Cidra, P.R., between 2001 and 2005. Also last year, Genzyme (now part of Sanofi) was forced to correct quality problems at its Allston, Mass., site, and Bristol-Myers Squibb received a warning letter from the Food & Drug Administration for manufacturing deficiencies at its Manati, P.R., plant.

Remaining compliant is becoming increasingly difficult for some companies. “FDA is being forced to send out more warning letters and crack down with fines, because the public is tired of story after story of contaminations and recalls and they are demanding changes,” says Brent Schludecker, president and founder of Midwest Compliance Laboratories, a Terre Haute, Ind.-based contract analytical and microbiological QC lab serving the food and pharma industries.

Monte Nagler
Quality Focused An Ash Stevens analyst carefully prepares a sample for the company’s testing laboratory.

At FDA, “guidance and enforcement practices, especially in the past several years, have indeed sought to focus additional attention on the importance of a pharmaceutical manufacturer’s management of quality,” according to Brian J. Hasselbalch, acting associate director of policy and communications in FDA’s Division of Manufacturing & Product Quality under the Office of Compliance.

For example, in 2009, FDA cosponsored an internationally harmonized guidance document, “Pharmaceutical Quality System,” to give specific recommendations for improving QA procedures and management practices to “achieve drug quality,” Hasselbalch says. In January 2011, FDA published a revised guidance document for the drug development industry, “Process Validation: General Principles & Practices,” which “provides the regulatory framework for development and ongoing verification of process control and product quality,” he says. Despite numerous efforts to communicate expectations, “today, more of FDA’s drug quality enforcement actions result from poor QC/QA practices” than they have in the past.

Even as drug developers work to keep up with FDA regulations, companies must also ensure they have the manpower to monitor international regulations, Schludecker says. Today, 40% of finished drugs and 80% of active ingredients and bulk chemicals used in U.S. drugs come from overseas, FDA estimates.

As a result, cost-conscious companies are leaning more on consultants and labs like Midwest Compliance Laboratories, which has been growing steadily and hiring its own QC chemists since being founded in late 2008, according to Schludecker. At the same time, drug and biotech firms are also moving more people into quality roles within their own organizations, he says.

Eli Lilly & Co., for example, has been bringing more chemists and engineers into its QC and QA areas “as needed to meet escalating expectations or guidelines set out by FDA,” says Carlos D. Vargas, a team leader in Lilly’s parenteral QC labs in Indianapolis. The company has met these human resource needs through hiring or by shifting scientists from other parts of the company, he says.

“Companies may have been downsizing on the discovery end of their business, but, if they have products in the pipeline, they are not going to downsize on the development end, which is where QC and QA scientists play a big role,” says Anjali Pandey, vice president of medicinal chemistry at Portola Pharmaceuticals in South San Francisco.

At Portola, QC and QA chemists work closely with the company’s contract research and manufacturing partners, managing supplier qualification, reviewing raw data and batch records, overseeing toxicology studies, and monitoring the stability of drug products throughout the duration of clinical trials, Pandey says. Portola’s two QC employees and three QA employees are responsible for “making sure that the product that is coming in is of the right quality.” In addition, if any deviations were to crop up during production of a compound ready to enter a clinical trial, for example, the quality staff would ensure that they were properly investigated and corrected.

With three products in clinical trials, Portola has worked to “beef up our QC and QA departments and bring in chemists, including some consultants, who understand that aspect” of the drug development process, Pandey says.

Genentech is another company that has bolstered the quality component of its business in an effort to meet complex global regulatory requirements, speed up the development timeline, and gain a competitive edge in the marketplace. As it has expanded its quality groups, the company has been slowly hiring chemists, biochemists, biologists, and other scientists into a quality product steward (QPS) role, which it created four years ago, says Glenn Smith, a QPS who is also a senior manager in Gen­entech’s clinical quality group in South San Francisco.

Jack Rose/Portola
Team Effort Discussing GMP data at Portola Pharmaceuticals are (from left) Dan Lee, senior QC scientist; Pandey; Kihlon Golden, senior QA associate; Christine Ye, director of analytical development; and Evan Susser, director of QA.

Each QPS provides quality oversight and acts as a single point of contact to manage all clinical QC and QA functions on the chemical, manufacturing, and control project teams, Smith adds. At Genentech, at least 15 people now work in the QPS role, including several who made the move within the past year, he says. These stewards focus on raw materials, environmental monitoring, in-process testing, drug product testing, viral and mycoplasma testing, quality documentation, and QA.

A QPS is assigned to a project team and stays with the project from preclinical development to product launch, accumulating a vast amount of product knowledge, Smith says. Those in the QPS role help facilitate “new, quicker-to-the-clinic approaches to development” and ensure that the quality of a released product meets predefined requirements, he adds.

Pharma and biotech companies are not alone in efforts to emphasize quality within their organizations. Those companies that supply services to drug developers are also beefing up their quality teams. For example, Watertown, Mass.-based contract research organization Wolfe Laboratories has been “vigorously expanding our services for the last few years to cover various aspects of drug development regulated under Good Manufacturing Practices (GMP) and Good Laboratory Practices,” says Verona Outerbridge, the company’s manager for business development and QA. Wolfe is in the process of increasing its quality staff, which currently includes seven employees responsible for QC and three dedicated to QA.

Detroit-based custom pharmaceutical chemical maker Ash Stevens has also been fortifying its quality team as a way to “attempt to differentiate ourselves in the marketplace, while placing a premium on acting responsibly and complying with regulations,” says Stephen A. Munk, the company’s president. Ash Stevens now employs 14 QC analytical chemists and six QA scientists, who together make up more than a quarter of its total workforce of 75 people.

The company is recruiting additional chemists or chemical engineers into its QA department. They will be asked to manage functions such as assembling documentation, including process and analytical reports and experimentation summaries. They may also oversee process and equipment validation work to support new drug applications. “Although QA is a writing and regulatory review function more than a laboratory function, I look for candidates with a master’s degree or Ph.D. in chemistry who have hands-on experience in manufacturing or process chemistry,” Munk says. “I want to be sure that they truly understand the chemistry behind what they are reviewing.”

Midwest Compliance Laboratories
Growth Mode Midwest Compliance Laboratories’ Schludecker recently hired two QC chemists and is looking to add a third to keep up with demand from pharmaceutical clients.

When hiring into quality roles, Portola, too, prefers to hire candidates with chemistry backgrounds, Pandey says. “Chemists are already trained in attention to detail, critical thinking, and problem solving—attributes that are important in QC. In addition, chemists are trained in doing analysis through high-performance liquid chromatography, mass spectrometry, and nuclear magnetic resonance, which helps in the characterization of a drug product.”

Medicinal and organic chemists, many of whom are still unemployed after the last wave of industry cutbacks, could transition into QC and QA roles, Pandey says. They may have an edge in identifying and characterizing process impurities and degradants and understanding how they were formed or generated during the manufacturing process.

Whether they come from a medicinal or organic chemistry background, scientists don’t need to have a Ph.D. to work in the quality arena at Portola, Pandey says. Scientists from a variety of backgrounds and all degree levels currently work in QC and QA at most pharma and biotech firms. At Genentech, for example, “many in our group have Ph.D. degrees, but several have bachelor’s degrees with industry experience,” Smith says. Those in the QPS role come from a broad range of backgrounds in QC testing, analytical development and validation, QA, or process development, he adds.

“Today, there is a serious need for talented people in the quality functions.”

Lilly is among those companies that hire freshly minted B.S. chemists into their quality management ranks. In fact, Vargas encourages new pharma-oriented chemists to start their careers working in a QC lab, “which allows them to get hands-on experience with state-of-the-art instrumentation and develop a good understanding of the GMP world.”

However, landing that first job on a quality team can be difficult for some new B.S. graduates. To gain an edge, Ash Stevens’ Munk advises young chemists to gain some experience doing undergraduate research either in an internship or within an academic laboratory. “Nothing does more to excite me about a young candidate than knowing that they have already conducted some kind of chemistry research, especially in organic synthesis,” he says. “If you are synthesizing molecules, you have to use instrumentation to look at purity, which helps you to develop techniques that are important to a QC bench chemist,” he says. To help fledgling chemists gain this kind of experience, Ash Stevens hires a couple of interns each summer, he says.

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In addition to having research experience on their résumé, candidates for QC and QA positions should educate themselves about GMP guidelines before they interview, Pandey says. “It’s now possible to do online searches and take courses to learn about FDA guidelines for characterizing a drug substance at different stages of clinical development, for example,” she says.

Candidates who have gained GMP knowledge by working in any FDA-regulated industry have an even greater advantage in landing QC or QA positions in pharma companies, says Heckman, who completed a four-month-long job search before joining Baxter Healthcare last month. Companies want to see that candidates “understand that good documentation practices and a complete audit trail are essential.”

Having experience working in QA at a cosmetics company helped B.S. chemist Alison Pinnell win her job as a QC chemist at Watson Pharmaceuticals’ Corona, Calif., site. “My knowledge of good documentation practices and good lab practices definitely gave me an edge in the application and interview process,” she says.

Another way to stand out among applicants for quality positions is to take engineering or business classes, Heckman says. For example, “prospective employers know that candidates who have completed engineering coursework probably have a good understanding of manufacturing processes and project management, making them more well-rounded and able to help the company gain a competitive edge,” she says. In addition, “drug companies know that a chemist with an understanding of business may be better prepared not only to contribute technically but also to contribute to cross-functional teams” that are central to their operations today.

Showing a willingness to step across disciplinary boundaries may be a big selling point for those seeking QC or QA jobs. “To be successful in these roles, it is important to have an outside-partner mind-set,” Pandey says. Those working in QC and QA need to be able to work with various outside contract manufacturing organizations and bioanalytical laboratories as well as participate in internal cross-functional teams that include analytical and medicinal chemists, toxicologists, and those involved in formulation, drug metabolism, and regulatory affairs, she adds.

At the same time, QC chemists must demonstrate an ability to work quickly.“I work with a very high volume product, so it can be stressful trying to keep up,” says Watson’s Pinnell. “You have to be able to handle some pressure, because releasing drugs onto the market depends on you.”

Yet she finds her work rewarding. “I like that I get to test products to be sure that they are free of impurities, have the right amount of active ingredients, and will dissolve in the time that we say that they will,” she says. “I like that as a QC pharmaceutical chemist, I am helping people get the medicine they need to feel better. I feel I am making a difference in the world.”

Lilly’s Vargas agrees. Recently, he was gratified to see that his young nephew was benefiting from using one of the insulin pens that came through his QC lab. “It is really satisfying being in the business of saving lives or helping improve the quality of life for people,” he says. ◾

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2011 American Chemical Society
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