Process development jobs continue to be difficult to fill
The biopharmaceutical manufacturing community continues to find it difficult to staff key positions, and is turning instead to outsourcing to fill the gaps. According to preliminary results from BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing, hiring trends continue to plague the industry, and it is finding relief by outsourcing some increasingly core activities. Results from the report indicate that experienced process development (PD) expertise is very challenging to find. And this is leading to an increasing number of companies looking to outsource their PD activities.
Hiring Trends and Difficulties
Early data from this year’s study suggest that the largest share of new hires this year – almost 43% - will be for production operations. If that result holds, it would be the largest skew towards production operation staff going back at least as far as 2008, likely reflecting the ever-tightening focus on operations and efficiency.
Meanwhile, the second-largest share of hires is for process development and R&D personnel. At close to one-fifth of projected new hires for this year, process development is clearly maintaining its importance in the hiring environment. In fact, these preliminary results indicate that process development might be becoming more of a hiring priority than basic R&D.
When we look ahead 5 years, we find respondents estimating that slightly fewer than 4 in 10 (38.5% of ) new hires will be for production operations, with process development relatively steady (16%) and regulatory/QA/QC gaining more prominence (18.8%).
Despite the sizable share of new hires for production operations, our data suggests that filling those positions will not be too much of a burden, at least relative to process development positions. To get a sense of hiring difficulties, we asked the industry to identify the job positions at their facilities that they are currently finding difficult to fill. The key problem areas are shown in Fig 1, and include:
- Process development staff, both upstream and downstream
- Process engineers
- Upstream operations staff
- Downstream operations staff
While operations positions are proving fairly difficult to fill, those figures are not too high relative to the influence that production operations have on the hiring environment. It’s perhaps more notable that such a sizable share of respondents attribute difficulties to staffing process development activities even as they account for a smaller share of projected new hires.
Figure 1. Difficult to Fill Jobs, Preliminary 2016 Data (Select Responses)
Figure 1. Difficult to Fill Jobs, Preliminary 2016 Data (Select Responses)
pThese areas have been problematic for some time now. For example, process development jobs have consistently been the most difficult to fill this decade, with process engineering and quality assurance also regularly in the mix in recent years. The early data from this year’s study portends a rebound in hiring difficulties for upstream operations staff, which have otherwise been on the decline.
Where Do CMOs Fit In?
It’s instructive to look at the positions that companies are finding difficult to staff, as these are areas that have seen increased outsourcing in recent years. There may not be a direct correlation between staffing difficulties and outsourcing, but our data suggests that at least some outsourcing may be undertaken in response to difficulties finding qualified talent.
Indeed, limiting our analysis to some of the most difficult-to-fill jobs, historical data from our annual studies indicates that:
- API biologics manufacturing outsourcing increased from 29% to 56% from 2010 to 2015
- Upstream process development outsourcing has more than doubled from 17.1% of respondents in 2010 to 43.2% in 2015;
- Downstream process development outsourcing has almost doubled, from 22.1% in 2010 to 44.1% in 2015; while
- Outsourcing of upstream production operations (42.1% last year versus 20.7% in 2010) and downstream production operations (38.9% and 27.9%, respectively) has also grown.
It’s true that more bioprocessing activities today are being outsourced, and at greater rates, and by a greater share of companies than in prior years. So the increases noted above might simply be a reflection of this general uptick in outsourcing. However, the more widespread outsourcing of these activities – many of which were previously considered too core to the business to outsource – elicits the possibility that if hiring difficulties persist, CMOs could be considered a worthy alternative.
Additionally, preliminary results from this year’s study suggest that some companies are planning to significantly ramp up their outsourcing of validation services and downstream process development. These plans may be in response to positive experiences, staffing challenges or a mix of these and other factors.
What remains unclear is the extent to which cost-effectiveness weighs into the decision to outsource specific jobs. Last year, when we asked respondents to identify various actions they have undertaken in order to reduce overall costs, we found a spike in the percentage of those who reported having outsourced jobs in process development to cut costs, from a range of 12-13% earlier this decade to a new high of 17.3%. This indicates that companies found outsourcing to be a cost-effective manner of dealing with this area of hiring difficulty.
Whatever the reason, the continued difficulties companies are facing in hiring for process development, production operations and validation (among others) suggest that CMOs should emphasize their strengths in these areas. With a strong and cost-effective solution, they may be considered viable longterm partners in place of internal hires.
Budget Trends Suggest the Money Is There
Preliminary budget trends from this year’s study indicate that biotherapeutic developers are earmarking funds to address any potential difficulties in hiring. Jobs that are difficult to fill may necessitate higher compensation from companies, which could allow CMOs to better position themselves as the cost-effective solution. However our data so far reveals that they’ll have to contend with rising budgets for staffing.
In fact, our preliminary data shows that more than 6 in 10 biotherapeutic developers will be increasing their budgets for hiring new operations staff and for hiring new scientific staff (62.5% of respondents each). We estimate that budget increases could be in the order of 6% for operations staff hiring and 5.3% for scientific staff. Relatively speaking, those are sizable increases: the data so far shows that these are larger increases than are planned for new facility construction and general in-house manufacturing, among others. Budget growth for outsourced biomanufacturing, by comparison, looks relatively modest, set for a 3.2% lift.
CMOs, for their part, are also looking to beef up their hiring budgets, with more than three-quarters planning increases in their budgets for new operations and scientific staff, with double-digit average increases estimated.
Why the Emphasis on Hiring?
Although biomanufacturers’ emphasis today appears to be on innovation and the emergence of new technologies and automated, flexible methods, the industry also recognizes the importance of skilled staff. In last year’s study, we asked the industry which factors are likely to create production capacity constraints at their facility in the next 5 years.
Our results showed that the most common likely culprits are facility constraints, analytical testing and drug product release, and physical capacity of downstream equipment. [1] But just below those were a range of staff-related difficulties:
- Inability to retain experienced technical and production staff (29.1%);
- Inability to hire new, experienced technical and production staff (28.4%);
- Inability to hire new, experienced scientific staff (28.4%); and
Clearly the industry sees the potential for the hiring difficulties outlined above to have a significant impact on their production capacity in the future.
While this may present an opportunity for CMOs, it’s important to remember that they’re themselves not immune to hiring difficulties. In fact, our preliminary results indicate that CMOs are even more likely than biotherapeutic developers to be concerned about the potential for staffing difficulties to impact their future production.
Looking Ahead
Key positions such as process development, validation and production operations continue to be challenging for the industry to fill. These have remained difficult for some time and are likely to continue being so given current trends in the biopharmaceutical industry.
The increasing comfort biotherapeutic developers have with outsourcing suggests that rather than filling these jobs, they may continue to outsource them to skilled providers, particularly if this proves to be a cost-effective alternative. Standing in the way of that opportunity for CMOs is an apparent budgeting emphasis this year on hiring on the part of biotherapeutic developers. Companies possibly have to increase these budgets in order to attract talent that is in short supply.
Some companies already report outsourcing jobs in process development and manufacturing in order to reduce facility costs. CMOs able to demonstrate the experience of their staff in these key areas could present themselves as an effective way for their clients to avoid the constraints associated with a lack of experienced staff.
But first they will have to win the war for talent.
References
- 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2015, Rockville, MD www.bioplanassociates.com/12th
Eric 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. [email protected] 301-921-5979. www.bioplanassociates.com
Survey Methodology: The 2016 Thirteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from well over 200 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in nearly 30 countries. The methodology also included over 164 direct suppliers of materials, services and equipment to this industry. This year's study 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.