给制药新人的建议让每一天都变得独特而富有挑战性

　　你是如何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/塞尔担任分析化学家，开始了我的职业生涯。我本来想成为一名医生，但最终决定为医生设计和开发药物。
　　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.
　　我相信，在制药行业的20多年里，我试图让每一天都变得独特而富有挑战性 。在任何特定的日子里，我都会努力保持自己跟上最新的FDA监管趋势，最新的技术创新和行业发展。同时，在工作中，我尝试通过战略会议来填补我的一天，制定业务战略，提出新技术和质量创新，以帮助我正在为之工作的公司/客户，从而最大限度地发挥他们的潜力/成功。上述所有项目都有助于我在IVT / CBI等领先制药协会上的知识和经验，作为过去18年以上的演讲者，同时还发表文章，领导网络研讨会和研讨会。总之，我致力于全球技术，质量和法规策略来帮助我的顾客和制药企业。
　　What part of this job do you personally find most satisfying? Most challenging?
　　你个人认为这些工作中的哪部分最令人满意？最具挑战性？
　　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.
　　我工作中最令人满意的部分是能够根据过去20多年来的技术，质量和监管专业知识为客户提供帮助。另外，我也非常乐意作为引领者在行业中寻找帮助制药企业发展的创新技术，技术，应用，方法等。我想到的一个关键的例子是2002年，当时我和一些同事在世界上第一个开发离子迁移谱（IMS）技术来作为新的应用，最初用于航天飞机上以确定空气质量。这个新的应用是使用IMS技术进行清洁验证，这种应用相比传统的技术（例如TOC或HPLC可能几小时/天）可以在几分钟内完成。
　　Do you have any advice for someone just starting out in the industry?
　　你对刚刚加入这个行业的新人有什么建议吗？
　　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.
　　我对刚刚加入这个行业的新人的建议是不断学习。我们永远不是真正的专家，应该不断学习。此外，我相信不仅要从头到尾学习你要做什么，而且要了解自己在做什么以及为什么要这样做的重要性。最重要的是，如果你在技术，质量和法规方面了解一些你正在做的事情，那么你现在和将来肯定都会很了不起 。
　　以验证专员为例，可参考以下目标，主管亦可跟进：
　　阶段
　　目标
　　阶段1
　　清楚验证团队所需要开展的日常具体业务
　　阶段2
　　熟悉并掌握验证团队所需要开展的日常业务具体要求和标准
　　阶段3
　　正式接手验证团队相关工作，小组内形成工作任务的分工与承担
　　阶段4
　　能够熟悉其相关的工程变更与确认（厂房设施、设备仪器、公用系统），对管理方面有一定的认识与见解
　　阶段5
　　能够管理与其相关的工程变更与确认（厂房设施、设备仪器、公用系统），以及熟悉可能的其他版块验证（工艺、清洁、包装、方法）以及计算机化系统验证的熟悉，对管理方面熟悉并掌握需要具备的能力核心要点
　　阶段6
　　在变更与确认的技术层面已经完全掌握法规的最基本要求，在管理方面可以协调并配合相关项目工作
　　阶段7
　　紧跟法规和技术进步，能够对现有的所有变更与确认（厂房设施、设备仪器、公用系统、工艺、清洁、包装、方法、计算机化系统验证）提出很多独到见解并做出相应的改进，与未来的短期规划和中长期规划想结合，在管理方面有部分建设性的想法和改进
　　阶段8
　　在变更与确认的技术层面已经达到一个较高水准，清楚行业相关书籍与法规的最新动态和趋势，在管理方面可以主导相关项目的开展，并能够对新生予以专业层面的指导和培训
　　阶段9
　　在变更与确认的技术层面已经达到炉火纯情的地步，在管理方面具备带领团队的潜质