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My posts are presented as opinion and commentary and do not represent the views of LabSpaces Productions, LLC, my employer, or my educational institution.

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Wednesday, March 23, 2011

I began a series of posts that explained how products are born, that is, how they go from a concept or idea to a product on the shelf waiting to be bought. So far we've discussed what R&D does and what marketing does to make sure that a product has the greatest possibility for success. Well there is another person on this team who plays a critical role in the product development process and launch.

While the title of this person can vary, their department is in operations and their function is to control and organize all the tasks required to get the product manufactured.  I want to talk about this leg of the product development lifecycle because I think it would be helpful to those of you looking at jobs in biotech and trying to figure out some of the job descriptions you might see advertised on websites. A position in manufacturing, QC, QA, or managing teams working in these areas are all viable job options for beginning and senior scientists.

Working in manufacturing is not the most glamorous of jobs but it does take a special skill set. It's not easy to take a formula that was made in 100 ml and now make it in100 liters, keep it sterile or bioburden free, and know how to get it from a tank into bottles. Or, if the company needs gram quantities of a recombinant protein, it requires a scientist experienced in growing cells in fermentation tanks and isolating soluble protein from large fractionation columns, compared to the R&D scientist who makes the same thing in a microcentrifuge tube.

Some scientists in manufacturing are running quality control tests of the products after they are kitted up and just about ready for sale. They are checking the work of the previous scientists who prepared all the solutions. These scientists are often bachelor level with experience in the lab (so they know how to use pipettors) but could also be master's level people.  This type of job is great for someone who wants to get into a biotech company, has some lab experience already and wants to see what working for a company is all about.

As I've mentioned before, once you have the job, moving around is easy. You can take time to figure out what interests you most and then figure out what skills you need to learn while you work. It's a great way to position yourself for a promotion to the next level.

In new product development, there is always an operations team leader that works with the lead R&D scientist and product manager. This person has a critical role in getting the product launched. There are so many minute details that need to be considered; everything from what sizes the bottles need to be, to what size the labels should be, to what box will it all fit in, to where to buy the chemicals needed to make the product, to lobbying for your product to get ahead of everyone else's on the manufacturing schedule, to what the QC protocol should be to prove the kit was made correctly, and so on and so on.

I've even been involved in discussions where we actually created a completely new box because too many customers said they didn't like the way the current box opened up! It turned out that people preferred one kind of flip top over another. So the operations team member takes the lead by contacting the box company and meets with a box engineer to tell them what the rest of the team wants, sends them the artwork, and has prototypes made for evaluation. Every little facet of the product is taken into consideration to make it more attractive to buyers.

The operations team member does not have a PhD but they may have a master's degree although it's not necessary. This person really needs to have an eye for detail and be able to multitask. They need excellent communication skills because they are the point person for getting things done with a lot of other managers internal to the company, like purchasing, manufacturing managers, and technical writers, and with outside vendors, such as the bottle and box suppliers.  This type of person is often called a project manager.

It's great if they know what a product is for but it's not necessary. The managers of the QC team and manufacturing team usually have enough science background to troubleshoot any issues with R&D about QC or manufacturing.

One thing I can tell you for certain is that without this operations team leader, the product development process would not be possible.

Operations encompasses a lot of different roles in a biotech company. They are usually the unsung hero because they do a lot of work to make products but are not mentioned when talking about the success (or failure) of a product. I've known quite a few people transition from operations to higher positions or different positions within the companies that I've worked so I believe the hard work is recognized and pays off.  The skills you gain and use (organization, multitasking, communications) are valuable in any role.

I wanted to give you something else to consider when searching for a way in to a biotech company. As I've said many times before, you can work your way up the ladder from any position. Be a leader and work hard and opportunities will open for you. Everyone wants to work with a leader.

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Dr. Girlfriend
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Hi Jade,

Do you know anyone who went back to academia after having spent time in industry? I remember being repeatedly ‘advised’ by people in academia (who have never working in industry) that one could readily transfer to industry at any stage but that returning to academia was challenging. This is why a number of people pospone getting a 'taster' of what industry is like. However, I did find one professor who, after 15 yrs in industry, applied for and got a tenure-track position (albeit with a significant salary cut!). More common seems to be for new PhDs, postdocs and junior professors to jump ship and never return. I suspect they tend not to return to academia because they don’t want to! How true is the myth that industry scientists rarely get the opportunity to publish if they wish?  

Brian Krueger, PhD
Columbia University Medical Center
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Great post, Jade!

I really want to be a box engineer.  That sounds like a super glamorous job :P

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Alphatine: I know two people who went from biotech back to academic, yes. If you want to interview them for your research let me know and I can connect you. I also know someone who went from biotech to a government lab in forensics.

I would guess that it is rare because the money is better but I suppose when academics is where your heart is, it doesn't matter. Hell, if I could, I would too. I just can't (won't) take a pay cut at this point in life.

Brian- believe it or not there are people who create these things. A lot of thought goes into the outer packaging of products. How it looks gets as much attention, sometimes, as how it works. Every product maintains many people's jobs. New products help the economy!



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That was a great post and very constructive advice.  The work opportunities are increasing, and it is a useful idea to bridge the gap on the information that can be very helpful to many people.  The point about this type of work being on a path to other careers was also accurate in my opinion, working in the jobs described in the post can prepare someone to be an effective manager of just about any type of business.

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Thank you Beth. That is exactly what I was hoping to convey to people. It is a good option for building a career and learning how a business runs. I bet there are many scientists who do love the science but would prefer more people interaction, are excellent at project management, keeping track of details and making teams all work together.

That's what this kind of person is good at or would learn to be good at. And managing others- so critical.

Also, I am pretty sure, most CEOs work, at some point, in operations. Operations is really the heart of the business, keeping everything running smoothly, so the scientists can create and the marketing people can sell.


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Fantastic post as per usual Miss Jade. Very imformative. Your posts always reinforce to me that there are other option besides TT type jobs and this is wonderful.  Thank you for sharing.

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Thank you Mystress!

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You are very welcome!!

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My supervisor spent several years as an industry scientist and then returned quite successfully to academia.  She knows many others that have done the same.  Given the direction of funding in this country, I wouldn't be surprised if in the future we see more of this sort of transition.

Genomic Repairman
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Dr. Girlfriend said:

Hi Jade,

Do you know anyone who went back to academia after having spent time in industry?

One of our faculty members is a reformed industry person.


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Hi Jade. Thanks a lot for this post. I found it when browsing through your older posts and it matches some questions I have right now about QC/QA roles. It was very enlightning.

I really like the concept of QA/QC, where you have to be aware of the process and interact with many departments. Would you think that someone with a postdoc would be considered overqualified for this role?


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I think a postdoc might be overqualifies for the lab role, because those are typically BS or MS. But it would depend on the company too. If the product were very complicated/ highly technical to manufacture or QC- then maybe not.

Some of the high tech companies, such as next gen sequencing manufacturers and the like might need PhDs for that.

But definitely a PhD would be qualified for the management roles. I think something like Six Sigma could be helpful to you. Many people in operations have a black belt in six sigma.

QA/QC people have to be strict and basically make sure everyone is following the rules. They can sometimes be seen as a hard ass and the person slowing everything down because they make sure that no one takes shortcuts. They really are important to an organization because they make sure that defective product never goes out the door.

There are times when a product doesn't pass QC and everyone wants to just make the QC easier or reduce the passing criteria and that's where a good quality person will tell everyone "nope".  If it can't pass, go back and make it again.


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