By Paul Thomas, Managing Editor
In step with FDA’s 21st Century GMPs, more drug manufacturers are working to better understand and control their processes. Biotechnology, and concepts such as process analytical technology (PAT), continuous processing and more advanced control promise to change the way that drugs are made.
As it considers whether to embrace this brave new world, the pharmaceutical industry also faces a critical question: Can the existing workforce handle the changes taking place? Will it be up to the challenges in store for it?
Experts within industry, the FDA and academia aren’t so sure. The industry just doesn’t yet have the right people, with the necessary skill sets, to move drug manufacturing to the “Desired State” where scientific principles define quality, they say.
“Manufacturers will need professionals with multidisciplinary skill sets combining process knowledge, process control, industrial IT, process analysis, multivariate analysis and Design of Experiments,” says Ingrid Maes, an Antwerp-based consultant for Siemens. “There are probably only 30 people alive who fit that description,” she says. “This is the real reason why PAT has not yet been fully adopted by the industry.”
Drug manufacturing professionals today do their jobs well and products released are of high quality, but industry expectations are rapidly changing. What was okay 10 years ago “is just not good enough anymore,” says Ray Scherzer, SVP of engineering, technology and capital management at GlaxoSmithKline. “Our manufacturing professionals will need to continue to expand their technical skills and gain even more expertise in the fundamental sciences that govern our manufacturing processes.”
“It’s like turning a battleship.
You have to get
the wheel and rudder
The rest of the ship will follow.”
— Ray Scherzer,
VP of engineering,
As manufacturing processes have become more complex, so have manufacturing jobs, he says. As a result, there is a need for stronger technical skills. Manufacturing professionals working in the industry today should have some grounding in chemical and mechanical engineering, Scherzer says. They should also be familiar with the concepts behind chemometrics, statistical process control and on- or at-line analytical and control technology.If they’re not to stifle progress, drug manufacturers will need to reorient their workforces, and to find new, innovative ways to train, reward and recognize employees (see Training with Some New Twists, below
). Academia will also have to change the way it teaches its students — both on the university level and on the “gold-collar” paraprofessional track (see Get Them While They’re Young, below
).What is needed, experts agree, is nothing short of a drug manufacturing workforce revolution. Can it happen?Yes, but it will take some time, Scherzer says. Most industry watchers expect it to take five to seven years, as training and degree programs are updated and upgraded, and students and professionals complete them. In addition, the industry will need to attract a different type of professional. Drug companies already have pharmacists, chemists and microbiologists, Scherzer says. Now they need more chemical engineers, as well as physical chemists, statisticians and rheologists. FDA has already moved in this direction by hiring more modeling experts. Industry will need to follow suit.To date, the most comprehensive effort to tackle the workforce training issue is ISPE’s (Tampa, Fla.) “Pharmaceutical Manufacturing Professional of the Future” initiative. The program’s goal is to identify the knowledge areas and skill sets that will be critical to the industry’s future. “We need to ensure that the people coming into the industry have the right skill sets to hit the ground running,” says Jon Tomson, a past ISPE chair who is leading efforts. Contributors from ISPE, FDA, manufacturers and academia are now just beginning to articulate those needs. Once that is done, the group will “take it on the road” and sell the objectives to manufacturers and universities, Tomson says.The training issue
The concept behind the initiative already resonates with many regulators and manufacturers, who note a serious disconnect between what manufacturing professionals can do, and what they will have to do from now on. “Right now, [during the manufacturing process], the guy on the shop floor doesn’t know whether what he’s making is the right quality of product or not,” says Ali Afnan, Ph.D., of FDA’s Office of Pharmaceutical Science. “He needs to understand what is special about his processes and how to manage them.” That means more exposure to engineering principles and some familiarity with skills such as multivariate analysis, process analysis and process control. It also presupposes an appreciation and understanding of other functions within the organization.Pharma’s tendency to “compartmentalize” is one of the major obstacles that training programs face. “Honestly, it will be extremely hard for companies to [adequately] retrain existing employees,” says Siemens’ Maes. “They’re used to a silo organization and it’s quite hard to change this [mentality].”But the silos must go. “The luxury of doing one thing doesn’t exist any more,” says Gail Sherman, VP of education for PDA (the Parenteral Drug Association; Baltimore, Md.). This is true for everyone in manufacturing. Courses at PDA’s Training and Research Institute were once populated by plant-floor operators, but they’re now also attracting supervisors, managers and QA/QC professionals, Sherman says.At industry’s request, PDA has expanded its curricula, adding training in biotechnology tools and processes. New courses mirror industry changes: validation of bioprocessing, cGMPs for bioproduction, quality systems, continuous improvement and Design of Experiments for PAT. “We’re trying to catch up with industry,” Sherman admits.PAT is a major area of concern, and a focus of ISPE’s efforts. Greater acceptance of PAT has caught many companies and universities off-guard.PAT will enable major advances in manufacturing and process control, “but we don’t have the right people with the right backgrounds to allow these advances,” says Jim Drennen, Ph.D., division head of pharmaceutical sciences in DuQuesne University’s School of Pharmacy (Pittsburgh). Even though it’s not universally accepted within the drug industry, “PAT is moving faster than companies’ workforces can handle,” he adds. Drug manufacturers will experience a lag time — sometimes two or three years — between the time when they draft their PAT programs and when they assemble the teams of individuals needed to carry them forth, Drennen believes.Small manufacturers will have almost no chance of attracting qualified PAT expertise, says Siemens’ Maes. As one solution, she is currently working with KVL University in Copenhagen to develop a Master’s Degree in PAT Sciences, a two-year program involving both lectures and practical, hands-on courses.But PAT is just one avenue to the future. “What we’re really talking about is taking batch processing and making it continuous,” says Jerry Roth, P.E., ISPE’s director of professional certification. “There’s no choice in getting the industry prepared to take on this challenge.”The workforce can adapt to continuous processing with “no trouble,” Afnan believes. More will be demanded of process development specialists, since continuous processing will require increased automation and streamlined product movement. However, it will ease some of the burden on the workforce. The challenge is designing it into existing processes, Afnan says.Manufacturers adapt
To navigate the shifting workforce terrain, manufacturers will have to maximize employee collaboration and cross-training, says Afnan. His past employer, AstraZeneca, required employees to assume multiple roles so that they could gain the cross-disciplinary expertise required, he notes.With some effort, GSK is finding good people for its PAT program and the company’s other 21st century initiatives, says Ray Scherzer. But it’s also developing the people it already has. The company is reorganizing to more closely link R&D and manufacturing and build greater development and scaleup expertise among its ranks, Scherzer notes. He is also working closely with his counterparts in R&D to identify individuals with the capacity to expand their roles, to give them rotational assignments between R&D and manufacturing, and to appropriately reward those individuals when they perform.Merck and Co. takes a three-tiered approach to determining how much individual employees need to know about new technologies and processes, says Lisa Alves, director of enterprise leadership. Most employees are trained so that they have an “awareness” level, and can demonstrate a general understanding of, for example, the company’s operational excellence initiative. There are also “skilled” and “mastery” levels, a Six Sigma Black Belt being an example of the latter. “We’re always making sure we’ve got the right people, with the right skills, at the right time,” says Alves.This month, Merck will receive an American Society for Training and Development “Best” award for the depth and breadth of its employee training. Key aspects of Merck’s efforts are simulated training environments for equipment operators and a business curriculum for employees based upon manufacturing case studies and simulation games.Such programs are “a business imperative,” Alves says. “A continuous learning culture is an absolute necessity.”Comprehensive employee training has been the key to successful Lean and 5-S program implementation at Wyeth’s Rouses Point, N.Y. facility. Training has also helped employees manage their career development, says Andy Crossman, director of manufacturing excellence and training at the facility. Lean and 5-S implementations haven’t presented staffing challenges because they’re fairly straightforward, he says. Rouses Point makes sure that 50-80% of its Lean training is hands-on, done in the plant, so that classroom learning is reinforced.Six Sigma projects are a slightly different matter, Crossman says. “There are Black Belts out there, but how many of them really understand the pharmaceutical process and regulatory environment?” he asks.Crossman believes that pharmaceutical manufacturers can, and should, commit more resources to developing employees to meet changing skill sets. His facility has multiple online training programs, and has collaborated with nearby Clinton Community College to design hands-on training for lab analysts and process operators. “In world-class companies, at least 15% of the workforce should be engaged in continuous education,” he says. “I don’t think our industry is there.” Individuals in highly technical positions should be in training 25% of the time, Crossman believes.Changes in the academy
Training the existing workforce will help meet tomorrow’s workforce challenges, but it won’t be enough. Higher education will have to step into the breach, especially in the U.S., where universities lag behind their counterparts in northern Europe, Korea, China and India. “There are plenty of Ph.D. candidates in Denmark whose dissertations are already in line with the Desired State,” says FDA’s Afnan. “You don’t find many in the U.S.”Manufacturers share the blame for the inadequacy of academic programs. “The industry hasn’t communicated to the academic community which are truly important skills,” says Scherzer. He’s taking that message to academics, and they’re listening.DuQuesne, for example, is aggressively pursuing a science- and risk-based curriculum that parallels FDA’s PAT initiative, Drennen says. A critical element is hands-on work in areas such as PAT laboratory techniques and statistical process control. The school takes this hands-on approach to its classes as well as the training it offers FDA and drug firms.Engineering education will be especially important, since engineers will be essential to bridging the historical divide between chemical development and process development. “We need more, and better, engineers,” says Piero Armenante, Ph.D., program director for the New Jersey Institute of Technology’s Department of Pharmaceutical Engineering (Newark).Armenante’s program, now four years old, offers certification and Master’s degrees in pharmaceutical engineering. Most students so far have been industry professionals seeking to broaden their knowledge base. Courses are taught by working professionals, and most of the course materials had to be developed in-house, Armenante says, because traditional texts did not take an engineering approach to unit operations.Making pharma careers “sexier”
But if they build it, will students come? Can universities attract enough students to fill classrooms with instructions in, for example, biostatistics?The problem has deep roots. Young people in the U.S. already have an aversion to technical professions, and most do not grow up dreaming of becoming engineers, process chemists or statisticians. “The money is there, but young people don’t see [a technical career] as glamorous,” says Scherzer.DuQuesne’s Drennen is convinced that young people will join the industry, because of the pull from an industry that has workforce gaps to fill. The industry pays well, he says, and there will be jobs.The Bureau of Labor Statistics estimates that the number of jobs in pharmaceutical manufacturing will increase by about 23% by 2012, as compared to 16% for other industries combined. Meanwhile, the National Science Foundation believes biotechnology and life sciences technologies will lead all high-tech sectors in growth.“Most of our students are asking, ‘Is it worth my while?’ ” says Russ Read, executive director of the National Center for the Biotechnology Workforce, based at Forsyth Tech Community College in Winston-Salem, N.C. Industry professionals returning to school get the message, but young people may not, Read says.Part of the problem is that high school teachers and guidance counselors aren’t well enough informed about potential careers in the pharmaceutical or biopharmaceutical industries. Read regularly visits North Carolina schools to clarify perceptions of biotech careers. He also works to provide high school and college students with opportunities to get hands-on research and manufacturing experience — to work with fermentation equipment, for example, to get a feel for what a biopharmaceutical career would be like.“If the U.S. is to maintain its dominance in biotech and manufacturing, it will need an orchestrated and synthesized effort,” Read says.Community colleges will be key to those efforts, especially in biotechnology, Read believes. As R&D-focused startup companies become larger biomanufacturers, they won’t be able to find enough, or afford, degreed employees. Gold-collar workers will fill the need. “The type of people we will need won’t require Ph.D.s or even B.S. degrees,” he says. “As manufacturing volumes increase and processes get more defined, companies will need more methodical, trained people.”From the plant floor to the site director’s office, pharmaceutical professionals of tomorrow will have to expand their repertoires. Manufacturers and universities will have to get with the program. It’s happening, but slowly, GSK’s Scherzer asserts. “It’s like turning a battleship,” he says. “You have to get the wheel and rudder turned first. The rest of the ship will follow.”
Training with Some New Twists To meet the needs of an ever-changing industry, manufacturers are seeking out novel training tools and programs to retool and refine their employee base. This is not only in their best business interest, but it also may aid compliance. “The buzz out there is that FDA is going to be looking much more closely at the effectiveness of training,” says Gregory Meyer, a consultant and president of Compliance Media (Palo Alto, Calif.).
Pixar for Production?
Any good trainer knows that hands-on simulation is the next best thing to being there, and beats PowerPoint slides or paper training manuals. Product Animations, Inc. (Chicago) is betting that 3-D simulation will be standard in companies’ future training programs and allow operators to learn equipment and SOPs faster and with more depth than is currently possible.
Both Wyeth and Merck & Co. are using the technology, called VRTrain. Training based on simulations of packaging operations was one reason Merck was recently awarded an American Society for Training and Development “Best” award.
Product Animations’ visualization engineers use CAD and the company’s proprietary software to create 3-D animated models of entire processing suites. Inexperienced operators, using a PC and mouse, can navigate the environment, learn equipment names and functions, and test themselves on their operating skills.
The company has created operating simulations of, for example, an Uhlmann UPS4 thermoformer and Glatt Wurster Coater. But most interest has come not from OEMs but from users like Wyeth and Merck. Using gross parts measurements, SOP manuals and videotapes of plant processes, Product Animations collaborates with manufacturers’ subject matter experts (SMEs) to create custom simulations of important processes.
“If you have an infrequent process for which operators always need a refresher on, this is perfect,” says Andy Crossman, director of manufacturing excellence and training at Wyeth’s Rouses Point plant. “Our operators like it because they can learn or review processes without the fear of making mistakes in a GMP environment.”
A typical customized simulation will cost roughly $50,000, and take two to three months to produce, Product Animations CEO Charles Roberson says. Beat that, Pixar.
Pharmaceutical Lean Manufacturing efforts have been hampered by a lack of personnel who understand Lean and can communicate its principles to their peers. Unfortunately, Lean training courses are all too often oriented towards other industries. “There is a limited number of people that have done Lean in a pharmaceutical environment,” says Izak Duenyas, Ph.D., a University of Michigan (Ann Arbor) business school professor. “Courses are often taught using aerospace or auto parts language. We think that pharmaceutical people shouldn’t have to translate this.”
Duenyas and colleagues in the schools of business and engineering saw a great need for targeted pharmaceutical industry Lean training, and have run several courses on campus and on-site for manufacturers such as Merck and Teva. The courses use industry lingo, and pharmaceutical case studies of Lean implementations.
Michigan’s Tauber Manufacturing Institute is sending teams of top students to manufacturers who have specific Lean projects. Last year, two students under faculty supervision helped Pfizer increase the capacity of its “kilo lab” scaleup facilities by 20%, which saved the company from spending millions to construct new labs. Manufacturers see the program as a way to get good Lean help at almost no cost, and to get the inside track on recruiting talent with Lean expertise, Duenyas says.
Tracking Employee Training, Electronically
When FDA inspectors come to a plant and ask to see employee training records, some manufacturers get out the stacks of manila folders and pray that everyone is up-to-date. Software vendors are resolving the compliance issue by automating recordkeeping of employee training.
MasterControl, Inc. (Salt Lake City) is taking the automation of training records one step further and asking employees to participate. “We’re trying to resolve an organizational behavior issue,” says Brian Curran, senior VP of product management and strategic marketing. “Employees aren’t participating in their own development, since their records are often kept under lock and key.”
With MasterControl’s solution, employee training records are maintained in an open database. Employees may access their electronic training folder at any time — to review their records, download training materials, get email alerts of upcoming sessions, or thumb through a course catalog of optional career development offerings.
The system aids the manufacturer by providing up-to-date information on the overall training status of the workforce — how many employees are certified to operate a key piece of machinery, for example. Should a regulation or SOP change, the system automatically identifies the subset of employees who will need updated training. The key is for manufacturers to be in a constant state of compliance in regards to training records, Curran says.
|Get Them While They’re Young|
Just last month, Atkins High School in Winston-Salem, N.C. opened its doors for the first time. What makes it unique is the fact that it houses a biotechnology academy that will offer students a focused curriculum, chances to take community college and university courses, and even internships with hands-on training.
Atkins is part of the New Schools Project, a North Carolina initiative to develop life science-themed high schools throughout the state. The project is part of a broader movement within North Carolina to develop a pool of talent that will continue to drive the state’s burgeoning life sciences industry — for manufacturing as well as R&D. The initiative involves state and local governments, universities, big business, chambers of commerce, community colleges and high schools.
Community colleges are being asked to play a major role in preparing students to “hit the ground running” as they enter careers. Winston-Salem’s Forsyth Tech, funded by a U.S. Dept. of Labor grant, has joined with four other community colleges nationwide to develop targeted training curricula and materials, and to provide a central repository of information that community colleges and other schools may access to create their own training programs. (The National Science Foundation is behind a complementary web-based project — visit www.bio-link.org.) Forsyth’s focus will be on training R&D professionals. Among the other schools involved, New Hampshire Technical College (Manchester, N.H.) is emphasizing biomanufacturing, while MiraCosta Community College (Oceanside, Calif.) will highlight bioprocessing.