给造药新人的发起：让每一天都变得奇特而富有挑衅性

你是怎样在你的企业起步的呢？

I started in the Pharmaceutical industry right after completing my Master’s of Science Degree in Biology with an emphasis in Chemistry. I began my career as an Analytical Chemist at Monsanto/Searle. I originally wanted to become a doctor but decided to design and develop medicines for doctors instead.

在完成我的生物学硕士学位后，我开始从事制药行业，重点是化学。我在孟山都/塞尔担当阐发化学家，开始了我的职业生活。我原来想成为一名大夫，但终极决定为大夫设计和开辟药物。

I believe that over the last 20+ years in the Pharmaceutical industry that I have tried to make each and every day unique and challenging. In any given day, I try to keep myself engaged with the latest FDA Regulatory Trends, up-to-date on technological innovations and industry developments. Concurrently, at work I try and fill my day with strategic meetings, developing business strategies, coming up with new technology and quality innovations to help the firm/client that I happen to be working for so they can maximize their potential/success. All of the aforementioned items contribute as well towards my knowledge and experience in leading Pharmaceutical conference like IVT/CBI as a speaker for the last 18+ years while also publishing articles, leading webinars and seminars. Overall, I try and focus on technical, quality and regulatory strategies on a Global level to help my clients and the Pharmaceutical industry overall.

我信赖，在制药行业的20多年里，我试图让每一天都变得奇特而富有挑衅性。在任何特定的日子里，我都市高兴连结本身跟上最新的FDA羁系趋向，最新的技能创新和行业进展。同时，在事情中，我实验通过计谋集会来弥补我的一天，订定营业计谋，提出新技能和质量创新，以关心我正在为之事情的公司/客户，从而最大限度地发挥他们的潜力/乐成。上述全部项目都有助于我在IVT / CBI等领先制药协会上的知识和履历，作为已往18年以上的演讲者，同时还颁发文章，向导网络钻研会和钻研会。总之，我致力于环球技能，质量和法例计谋来关心我的主顾和制药企业。

What part of this job do you personally find most satisfying? Most challenging?

你小我私家以为这些事情中的哪部门最令人中意？最具挑衅性？

The most satisfying part of my job is being able to provide assistance to clients based on technical, quality and regulatory expertise over the last 20+ years. In addition, I love to truly be a trendsetter in the industry in finding innovative technologies, techniques, applications, methods, etc. that help the Pharmaceutical Industry advance. One key example that comes to my mind is in 2002, when I with some colleagues, were the first in the world to develop a technology which is called Ion Mobility Spectrometry (IMS), originally used on the Space Shuttle to determine air quality for a new application. This new application was for cleaning validation utilizing the IMS technology and developing this new cleaning validation application which could be executed in mere minutes vs standard technology such as TOC or HPLC which could days hours/days.

我事情中最令人中意的部门是可以或许依据已往20多年来的技能，质量和羁系专业知识为客户提供关心。别的，我也非常高兴作为引领者在行业中查找关心制药企业进展的创新技能，技能，应用，要领等。我想到的一个要害的例子是2002年，其时我和一些同事活着界上第一个开辟离子迁徙谱（IMS）技能来作为新的应用，最初用于航天飞机上以确定氛围质量。这个新的应用是利用IMS技能举行干净验证，这种应用相比传统的技能（比方TOC或HPLC大概几小时/天）可以在几分钟内完成。

Do you have any advice for someone just starting out in the industry?

你对方才参加这个行业的新人有什么发起吗？

My advice for someone just starting out in the industry is always to keep learning. We are never truly experts and should be continually learning. In addition, I believe that it is very important not only to learn what you are doing from beginning to end but to also learn the importance of what you are doing and why you are doing it. On top of that, if you sprinkle a little learning the technical, quality, and regulatory sides of what you are doing then you definitely will be in great shape for the present and future.

我对方才参加这个行业的新人的发起是不停进修。我们永久不是真正的专家，应该不停进修。别的，我信赖不但要重新到尾进修你要做什么，并且要相识本身在做什么以及为什么要如许做的紧张性。最紧张的是，假如你在技能，质量和法例方面相识一些你正在做的事变，那么你如今和未来肯建都会很了不得。

以验证专员为例，可参考以下目的，主管亦可跟进：