Government Alumni Spotlight – Food and Drug Administration (FDA)

Throughout April, Career Services hosted a series of online chats with graduate alumni working for the federal government.  On April 9th, we heard from a bioengineering PhD graduate who is working as an assistant director in the FDA’s Division of Spinal Devices.  Below is a summary of his experiences and advice for current Penn graduate students.

How he began to think about a career in industry/how he explored the interest

  • Studied mechanical engineering as an undergraduate. Attended a school with a lot of research opportunities for undergraduates and was able do work closely with a faculty member who studied the mechanics of the human spine.
  • Loved studying the spine and its load bearing functionality.
  • Undergrad professor had done a lot of research on biomechanics in Philadelphia – this led him to study bioengineering at Penn.
  • Doctoral work was focused on biomechanical research and conducting mechanical tests on the vertebrae – lots of work with MRIs and gained a lot of experience related to mechanical devices for the spine and evaluated these using goat models.
  • Grew up in academic family, and academia seemed a natural path but as he progressed through his dissertation work, he recognized that he had less interest in grant writing and the other components of being a PI.
  • He felt he was both over- and under-qualified for jobs in industry. His thesis was on device evaluation and not design, which was what industry often wanted – the FDA was a good fit for his evaluation skills.
  • Working at the FDA at the start is kind of like an industry related postdoc – very broad look at what is interesting in industry – many people take their skills outside of the FDA eventually because of their regulatory knowledge.
  • A postdoc is not necessary for these types of roles.
  • Working at the FDA in the medical device area is almost like an agency within itself – he does miss creating new things instead of evaluating the creations of others, but he really enjoys having exposure to the latest spinal devices and feeling like he has a big say in things that deeply impact people’s lives.

How he applied/the structure of the application and interview process/ Advice for interviewing/how and when to apply

  • USA Jobs is difficult to navigate – partially because it is so big. All applicants must go through this process to apply.
  • No one can be hired at the FDA without first applying through USA Jobs. HR then goes through the applicants and decided who is “eligible to hire”.  This can be a long approval process.  He had 11 months between when he first inquired and when he started – this is longer than usual for most candidates (but it is a long process).
  • He reached out to a contact at the FDA given to him by his advisor and they interviewed him relatively quickly – he then had to start over at the beginning of the process by applying through USA Jobs and then a long wait to be “eligible to hire.”
  • As someone who now interviews candidates, he only interviews people who have already been qualified to hire in order to keep the process moving – so he encourages people to apply early.
  • Brevity is not required for the federal government, so having a long resume/CV is fine.
  • Key works are important in a resume – tailor your language to what you are applying for, be specific, and the longer, the better.
  • Federal agencies pool their resources and applicants, so once you are qualified to hire, you may hear from different managers.
  • US citizenship is not required, but definitely helpful. They hire people with master’s and undergraduates – a master’s in regulatory affairs is a plus.

Transitioning from academia to industry

  • He had a handful of paper to finish up from dissertation work. These did not need to go through ethics at FDA; some do, depending on what they are working on as a graduate student and at the FDA.
  • The FDA is pretty isolated from other federal agencies, and there is not much interaction at the entry level. This increases as you move up – some interaction with NIH, Walter Reed Hospital.  Make an effort to interact when you can!
  • He focused on the approval of spinal medical devices; the FDA also approves COVID tests, ventilators, masks.
  • He started as a reviewer, and is now a supervisor of a team of reviewers.
  • Daily activities – reviewing submissions from companies on these medical devices, and then issuing reports on these devices. Documents he reviews are from 300-800 pages – they are assigned to a reviewed, who usually has a case load of 5-10 reviews at a time.  FDA guidelines require a 60 day review.  He prioritizes his work based on deadlines.
  • He is now a lead reviewer in charge of looking at all submissions and “consulting out” those that require outside expertise.
  • A key skill is communication skills to interact with those both in and out of the FDA – he spends 10-20% of his time speaking with companies on how they need to revise their submission – the legal bar is set that their device has to be as good or better than something else on the market.
  • He is an unusual case in that he has a direct line from his research to what he is doing now – most new employees in the review area do not have such specific expertise. There are a few areas that do require more specific expertise – microbiology.
  • All lead reviewers have supervision and never independently approve devices – there are 13 people on his team and he signs off on everything they do.
  • 70-80% of the submissions have 1 lead reviewer – more complex submissions could have a team of up to 10.
  • Most new employees do not have regulatory background – although this would certainly be helpful.
  • For the first 6-12 months, new employees have a mentor they work closely with. In the first few months, he spent 1-2 days a week working on a reviewer certification program.

Work/life balance before and during COVID, salary information

  • FDA headquarters are in DC, there are 200 sites around the country, but most of them are field offices focusing on inspections. 16,000 employees – only 2,000 work in the Center for Devices.
  • Prior to COVID, he worked from home 2 days a week; so the infrastructure was already there to support remote work. Rare for anyone to work remotely full time.
  • Does not think they will be 100% remote going forward – likely to work in the office 2-4 days a week.
  • Hours are very set – works 40 hours/week. If he works more than this, he earns vacation credit.
  • FDA is not easily accessible via public transport, so most employees drive.
  • Follows federal salary grades. Very little flexibility in negotiating for a different salary grade.  Sometimes you can negotiate for a different step within a grade.  Most PhDs hired at a GS 11.
  • Do not need to apply for promotions – you are automatically considered. As a lead reviewer, you are up to a GS 13.  Higher than a GS 13, you need to apply for promotions.

How he was involved as a student at Penn, and how this helped

  • His primary activity outside of academic work was through his church.
  • Had been involved somewhat with Penn Biotech Group.
  • Wished he had spent more time learning/exploring what industry valued; learning the acronyms used outside of academia.

Other tips

  • RAPS certification is helpful but not necessary – this is more needed in industry as they are pre-market focused.
  • USPHS commissioned Corps – about 10% are in this in the FDA. They have a different payscale/retirement plan than other employees.  They wear uniforms and can get deployed for other public health issues/emergencies.  But they gain the perspective of other aspects of public health.
  • ORISE Fellowship – this can get you in the door, but the clock does not start for federal service and pension until you finish the pension.

Click here for notes from our chat with alumni who works for the U.S. Environmental Protection Agency

By Dianne Hull
Dianne Hull Dianne Hull