Looking to Learn Method Development

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Hi! I am currently working as a QC Analyst in a pharmaceutical facility in New England, with 6 years combined experience. We mainly test small molecule compounds using HPLC and GC. I am very interested in HPLC Method Development, but am not sure how to get my foot in the door. My company has no positions available and is not keen on me shadowing someone in the R&D department to learn. At my last job, I did some work on development and validation, but really just tested what they wanted me to do. I do not have my Masters degree--do they offer a Masters degree at universities with an emphasis on Method Development? If not, how does one get involved in this field? Surely, a company won't hire me for a Method Development position if I don't have experience doing it, and I can't get experience unless someone hire me, right? What to do? My resume highlights my 6 years of experience, but I can't lie and say I have extensive development experience. Help!!

It sounds like you need a new job as a QC Analyst in an environment where they will let you grow or switch between divisions... I am not aware of a Master degree solely on method development...

There are ways for you to get involved in method development, but they may not be at your current employer. One question I would have for you is do you understand the concepts behind HPLC and sample preparation techniques, or do you just understand how to do them reproducibly? Some people I have met in QC are well versed in regulatory requirements and good documentation skills, but lack the scientific understanding for what they are doing in the lab. If you lack that understanding, I would first recommend you take some training courses in method development.

The best way to try and see if you can do any method development work at your current employer would be to try and put something in your yearly goals about optimizing a couple methods in your lab. Maybe there are a couple methods that are more troublesome than others you could tackle. It could be difficult in a QC lab to change them though. If you can put it in your goals, then you can stress the importance to your supervisor that you get some MD experience, if only to accomplish the goal.

If none of the above work, you could look at taking a job at a contract laboratory (CRO) which develops methods for many pharmaceutical companies. There is a lot of routine work usually involved with these jobs, but you can hopefully pick up some new skills as well (method development). From there you may have more experience to take a job which is more method development and less routine.

Thanks for the replies…
Another question: I am sure there are many contract laboratories in the Boston/Greater Boston area (if you know of any of the tops of your heads, let me know!!) that I would love to work for. How do I successfully sell myself to them? I only wish I had plenty of method development experience to brag about, but I only have a little bit. From the standpoint of a hiring manager, what skills can a good QC chemist offer their company? What should I highlight that will appeal to them? And thanks again for all your help, Forum! :D

A good start - find this book, read it.
ISBN: 978-0-471-00703-6

How are your methods transferred to your QC lab? Any chance of you participating in the method transfer process? Or getting first run with the new methods? Volunteering for second analyst as a gateway between the labs?

Depending on your situation, being in the QC lab may work to keep you away from method development. I have run across the view that management wants the QC to know only how to run the methods, not change them -- lest they make changes that result in compromised data. (Don't ask the question of how analysts can adjust a method to keep it running without knowing how to change them. Or how one draws the line between what constitutes a good change as opposed to a bad change for an QC analytst to make even though both may appear to improve the analytical results.)

So how do you get to make changes in a method without getting in trouble? Your idea of a master’s degree is not a bad idea. You can go play with a university's LC. As far as specializing in method development, be a scientist who solves problems and among your set of skills is some good analytical chemistry. That masters degree: Find a program that has work that needs good analytical chemistry. For example there may be an environmental program looking at emerging environmental contaminants. And, you can offer to look for a series of compounds that may or may not be in local waters. Your thesis may be on the sampling of the harbor in a number of places to look for various contaminants. But it is supported by methods you developed.

The proof of good method development is that the methods meet objectives of applicable detection limits, selectivity, robustness and such. And the reason why emerging pollutants came to mind is that pharmaceuticals was mentioned above - and a number of pharmaceutical related compounds are showing up in the water around us.

If you take the direction of the master's degree, just remember to pick something you enjoy. You will spend many hours with it and in this economy, you may not get a job change out of it. Which reminds me...

I remember researching blood clotting chemistry and seeing a paper on the blood clotting proteins in lobster. Someone did some good protein chemistry and had fun at the same time. (I can make my guesses as to what happened to the sacrificed lobsters.)

Work hard and don't forget to have some fun.

Work in consumer products field, in a company with a small staff. We constantly develop new test procedures to solve manufacturing and R&D issues. The pharmaceutical regulations keep changing, like now the FDA is investigating how companies QC their incoming raw materials to ensure that suppliers aren't doing economically motivated adulteration (e.g. melamine issue).

the pronlem you said i met too ,as a member in the company's QC department ,the manager just want you to do some routine works .i had ever satyed in the qc of a pharmaceautical cimpany when i graduated 4 years ago .now i am working as a analyst in the goverment .not same with you analysis different samples of medicine ,and certaily there is much same boring and no chanlenging chance for you to development a method .what you do is under the standard principles said in pahrmacopia .
it is same al over the world .whether india or china .
the important is that what you want and what you can do in your job ?
first ,i think you can read the book provided by upper posted .it is a classic books in our field ,i am now reading it ,and get more edeas from it .
and second i think you should do some research in what you analysis everyday . what and why ?do some questions .and dig out why .
if you can not get what you want such as developement method.you can go to college to get a master degree that involves method development .but i think you can get more from cro than in college .just my view .

larryaducady wrote:
Thanks for the replies…
Another question: I am sure there are many contract laboratories in the Boston/Greater Boston area (if you know of any of the tops of your heads, let me know!!) that I would love to work for. How do I successfully sell myself to them? I only wish I had plenty of method development experience to brag about, but I only have a little bit. From the standpoint of a hiring manager, what skills can a good QC chemist offer their company? What should I highlight that will appeal to them? And thanks again for all your help, Forum! :D

One of my first jobs out of college was a Temp position in a QC lab of a pretty big company. When my contract was up I interviewed for a temp-to-perm position in R&D (another company). The biggest question was why I wanted to go from QC to R&D. Emphisizing the fact that I wanted to get more involved in Method Development wasn't hard. I just said that basically in QC the methods are treated as "black box" methods. We input sample info, press "RUN" and get data. I expressed I wanted to be in a field to put all my college and post-college lab experience to the test. I expressed that I desired to know the way things work, and the inner workings of the method and instrument, and to me that's where the chemistry is.

Disclamier: No offense is intended to any QC people here.

It is not experience you need for methods development, but understanding the rationale behind a good method.

The analyte of interest is in a matrix - even a "pure" compound has a "minority matrix" of impurities - and the purpose of the method is usually to determine the analyte of interest easily, to a required degree of accuracy.

The pharmacopoeal methods do not contain much chemistry - they are mainly recipes, without explanations. You can learn a lot from QC work by teaching yourself to understand the chemistry behind those official methods, such as how an extraction takes the analyte out of the matrix, and into a form which can be easily quantified.

Thinking about what you are doing is a very good start.

And don't assume that "the book is always right". The methods in the pharmacopoeas were written and tested by people like you. Mostly they get it right, occasionally they get it wrong - but nothing changes if a bad method is not challenged.

Small molecule method development by HPLC, GC, MS, IR, etc can be learned in an analytical chemistry degree.

My small department only offers chemistry degrees, but in those degrees are biochemists, electrochemists, inorganic and organic chemists. I have taken every grad level analytical class that my school offers.. and I successfully joined the lab of a person who focuses on method devel with mass spec (right time, right place).

So basically you will check out the professors in universities in your area to see if they do work in a field that you find interesting.

..btw, I didn't start out know exactly what I wanted to do. As a undergrad I did some electrochemistry (not my thing), then some blood clotting biochemistry, and found that I really really loved purifying the clotting proteins. Thats how I became interested in analytical method development...

If you want to work in the "methods development" area, academia is actually a better place than industry.
In industry, there is always someone who resents you, either because they see you as competition, or because they dislike you being "smart".

If you are good at methods, people you work for actively discourage attempts to promote you into other posts within the organisation, because they are unlikely to find anyone as good as a replacement.

If there is a separate methods department, you are waiting for the boss's job - "dead man's shoes".

My advice - if you get an understanding of methods work, use it as a lever to get into Regulatory Affairs - that is where you can make money, but it is boring paper shuffling. When you have made the transition to making a decent salary, you can start applying for jobs at the higher salary level, and cite the fact that you are fed up of shuffling paper.

Wish I'd done it myself. I've given that advice to three people, and it worked (granted, two of them had a PhD to start with).
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