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Budgets up for Hiring Biopharmaceutical Production Operations
By Eric S. Langer

Good news for the biopharmaceutical industry: After a few years of dismal waves of layoffs, budgets for hiring in production areas are up significantly this year. In fact, our 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production [1] shows that the budget cutting has reversed from just 3 years ago, when the global industry was showing a 2.3% cut in budgets for hiring of production staff. Now, we’re seeing a dramatic upswing and budgets for hiring are up 3.5%. This represents one of the biggest turnaround swings among the 12 budget areas we measured this year.

BioPlan Associates’ annual biopharma manufacturing report aggregates responses and trends from 352 biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 31 countries, and 186 suppliers to this industry. The study covers new product needs, budget changes, capacity constraints, disposables, downstream purification, quality management, hiring issues, and others.

This year, our analysis also found that the ‘Inability to hire new, experienced technical and production staff’ was the #2 factor creating manufacturing capacity constraints. Over 31% of companies indicated this is problem, up from 24% last year. This suggests that budget cuts may have gone too far, and that the economic uncertainty has stabilized to the point that hiring is becoming a critical operations factor now.

Hiring Situation
Over the next 12 months, biotherapeutic developers and CMOs will bring on board a variety of new staff. Of these, 33.2% (compared to 34.8% last year, and 34% in 2009) will be involved in production operations, and 21% (16.2% last year, and 15.6% in 2009) will be involved in process development and R&D. “Other” will account for 6.7% of the new hires (9.3% last year, 8.3% in 2009). Regulatory or QA/QC departments will account for 13% of the new staff (14.8% last year, and 15.8% in 2009).

Fig 1: New Hires in Biopharmaceutical Manufacturing (2011)

Fig 1: New Hires in Biopharmaceutical Manufacturing (2011)

Continued Growth in Biopharmaceutical Manufacturing Jobs
The growth in the biologics sector over the past 10 years has led to demand for scientists with operations and process engineering backgrounds. This demand, driven by fewer applicants to these positions, is creating some concern about shortages in biopharma manufacturing and process personnel. This gap is reflected in respondents’ concerns about inability to meet capacity requirements. The enormous pressure to avoid manufacturing bottlenecks may be resulting in the budgetary (salary) increases we are seeing in the study. It is possible that these positions will become hot opportunities if the demand pressure continues to increase salaries.

Hiring Challenges Today
In the study, we asked respondents, “Which job positions at your facility are you currently finding it difficult to fill?” While hiring of process development professionals was the most commonly cited area, hiring of process engineers was third, indicated by 32.7% of respondents.

Companies want to make their process more efficient and less expensive, and want to do more, with less. So it is not surprising to see in this year’s data (as well as last year’s) that the top three most-difficult-to-fill positions are process engineers and specialists for both upstream and downstream process development. These employees are difficult to find, difficult to recruit, and difficult to retain. Salaries are reportedly higher than in other similar positions because of this shortage. Finding good downstream processing specialists and cell culture process engineers has been a challenge for at least 10 years, and no major changes appear to be occurring in academic institutions to fill these vacancies. The way these skilled employees are produced is through internal training, which leads to ‘poaching’ from one company to another. Many industry observers believe that to break this cycle will require stronger relationships between employers, leading universities, and community colleges.

We also compared the areas in which biomanufacturers are finding difficulty filling positions over time. From last year to this, we see that many of the harder-to-fill positions last year are increasingly difficult to fill this year, as well. The percentage of companies finding it difficult to hire process development, professionals grew, as did process engineers, which are increasingly in demand. Other areas of growth include senior staff management, quality assurance, and validation.

Manufacturing process engineers lead the way in terms of talent scarcity, and the trend is likely to continue. Some biopharma companies, hit by competitors’ poaching, have decided that it is a better proposition to join the bidding process than invest in training that will ultimately not pay off. This has the effect of shrinking the numbers of process engineers, relative to the demand, thus escalating the problem.

Process Operations: A Learn-As-You-Go Career
Broader solutions will involve education, training and incentivizing. These are necessary to resolve the current underinvestment in biopharma operations staff. Industry and academia are coming together to find ways to train and educate more effectively. Johns Hopkins University’s Center for Biotechnology Education, for example, includes master's level programs in biotechnology. On the training side, community colleges are beginning to develop and expand programs in these areas, as well.

Survey Methodology: The 2011 eighth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production in the series of annual evaluations by BioPlan Associates, Inc. yields a composite view and trend analysis from 352 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 31 countries. The methodology also encompassed an additional 186 direct suppliers of materials, services and equipment to this industry. This year's survey covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world's major markets in the U.S. and Europe.

REFERENCES
[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April, 2011, BioPlan Associates, Inc. www.bioplanassociates.com

About the Author:
Eric S. LangerEric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing,” and many other industry reports. elanger@bioplanassociates.com 301-921-5979. www.bioplanassociates.com
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