CBER chief discusses hiring and retention challenges brought on by remote work

The head of the US Food and Drug Administration’s (FDA) biologics center said that while work-from-home culture has enabled it to hire remote staff who otherwise would not have been able to work for the agency, it also threatens to entice staff to the private sector.

Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said he’s grateful for the added funding to hire high-level staff through the 21^st Century Cures Act and the recent Prescription Drug User Fee Act (PDUFA VII) reauthorization during a webinar hosted by the Alliance for a Stronger FDA on 4 April. He also noted that the agency is still struggling to fill positions, especially since the kind of staff they are looking for are in high demand in the private sector.

“Even though the 21st Century Cures salaries are good, and I am very grateful because without them we would be smoked,” said Marks. “Unfortunately, with really good people and the industry where it is now, there is a lot of opportunity and with the new economy where people can switch jobs without having to physically relocate, it's to our advantage, but it's also to our disadvantage,” he added. “We've used it to our advantage to be able to recruit some people who could not move immediately, that's great. Unfortunately, it also means that some of our people have been picked off to go elsewhere.”

The CBER head said that means that the agency must try to attract people in other ways beyond salary to make the workplace at the agency one that is more diverse and empowers its staff as much as it can. He added that he plans to use such what he calls soft tools “to the max” alongside better salaries to make it a workplace of choice for his staff.

Marks also said that in conjunction, the agency plans to use fellowship programs and training junior-level staff to address its staffing needs.

One key area that CBER wants to focus hiring on is finding staff with expertise in manufacturing, which Marks noted is a top priority for industry. He said manufacturers want to have timely and accurate information from his staff in areas such as manufacturing and other non-clinical issues.

“In order to train up people who are more junior, we're going to need some more people who have essentially mid-career experience to be able to do so,” said Marks. “I'm not saying that we're not also looking for entry-level people, we very much are. But … some of that also means focusing on getting into mid-career level people who can help set the training, help provide an example for junior people.”

The COVID-19 pandemic has pushed private and public organizations to embrace the work-from-home culture, which has allowed organizations such as FDA to keep operating. But the issue for both industry and government, as Marks points out has been an evolving one as offices have used a hybrid workplace model.

“We'll have to evolve with it over the coming few years,” he added. “I don't think we've settled yet on what this is going to look like, which means I think we still have to do some adjustments over the coming few years.”

While the new funding has enabled CBER to increase its hiring ability, Marks noted that the “great retirement” and the fact that many of his staff are being poached by private industry is still causing a hiring challenge. Ideally, he said that he’d like to get vacancies at CBER below 10%.

“We still also have to deal with the challenge of a staff that is in high demand in private industry, particularly in the areas that we most want to retain, that is things like gene therapy, chemistry, manufacturing control (CMC) experts, and people with manufacturing expertise in those areas,” said Marks.

He added high-priority staff such CMC reviewers, statisticians and epidemiologists are also in high demand in other tech jobs that often are not related to healthcare.

Another key topic Marks raised during his talk is FDA and public health experts in general need tools to track infectious diseases to prepare for the next pandemic.

“If we don't end up with a national surveillance system that allows us to actually have real-time data on what's going on with infectious diseases in the country, we're going to be laughing stocks,” said Marks. “We have data systems for commerce that are magnificent and yet we don't know in certain states in this country whether people are being infected with COVID at various rates with any degree of certainty.”

He acknowledged that there are concerns about patient privacy, but he insisted that kind of data can be protected through encryption and technologies such as blockchain.

“That’s actually the job of government… to be ready for the next nightmare to come along,” said Marks. “We need the tools, which means the surveillance systems that will help us know both the diseases that might be coming through the population as well as the safety of the products that we roll out.”

CBER chief discusses hiring and retention challenges brought on by remote work

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