So, I realized that all my posts since I got here have been about travel and fun, and I figured that I should go ahead and tell you more about the actual internship.
I am working at Novartis Vaccines and Diagnostics. Novartis is a huge overarching company that dabbles in pharma, vaccines, and generics. The vaccines division is actually pretty new; in 2007, Novartis acquired an existing vaccines manufacturer called Chiron.
The site where I work is in Rosia, Italy. It is a manufacturing site that does bulk manufacturing, aseptic filling, and secondary packaging. There is also another site in Siena, Italy (which is where I live, 20 minutes away), but this facility is a bit more research focused. Rosia is out in the middle of nowhere… hence, why I live in Siena.
My actual project is to evaluate the current batch record process and streamline the process to increase “right first time” rates, as well as decrease cycletimes. The idea is to get product done right, and get it done quick. Pretty good goals, I would say…. Isn’t that what manufacturing is all about?
If you’re not “in the know”, a batch record in biotech/pharma is a pretty critical thing… it’s the documentation that serves as the primary record of everything that happened to that batch, and the batch records must meet a multitude of compliance and regulatory critierion. The kinds of documentation that must be included in the record is actually dictated by the FDA and other government agencies, so it’s definitely an important document. As such, since there is so much regulation, the batch records can be cumbersome to use, leading to issues. My goal is to streamline the batch record, while still meeting all the regulations and compliance criterion.
In addition to completing the project my company needs to be completed, I am also here for myself…. I have to get all the relevant data and info I will need to write my thesis for graduation. Sometimes, I sort of feel like I have two bosses… my thesis supervisors and my actual work supervisor. In most cases, they agree (so far) on my approach, but I have definitely had to make some compromises between the two groups on minor details, etc.
Like many LFMs, when I first go here, I spent some time doing literature review (reading other LGO theses), trying to see how other LGOs had approached their internships. I also had a lot of meet and greet activities, just trying to get to know the site and all the key resources. Once I got started, I really worked to focus my scope; I wanted to really firmly define the problem statement and goals. Next, I had to make my team. I spent a lot of time figuring out who the right resources were, and gaining permission to pull resources onto my project. Next, I did some chartering activities to make sure that the entire team was focuses on the same goal.
In my actual project, I am evaluating batch records for both bulk manufacturing and secondary packaging. Its good and bad….. good in the sense that I get to work with two totally separate processes and groups of people. Bad in the sense that it’s sometimes a hassle to schedule around everyone’s schedules :) The groups are really different…. One group tends to be a bit more reserved, and one group is totally passionate and loud. It’s always a change to move from one project team meeting to another.
At this point, I am in the stage of defining and gathering data. I have worked with my teams to determine which metrics will be the most useful to understand the current state of the system. I am doing quite a bit of data mining of data that already exists, as well as collecting new data to really understand the current state.
Once I understand the current state, we can figure out where our biggest opportunities are, and we can work to think up and implement solutions… the idea is to implement solutions while I am here so that I have time to get real data after implementation to determine if my solutions were actually beneficial (or not). It’s a lot to do in 6 months, but I’m really excited for the opportunity to DO something on my internship, instead of just working to deliver a model or an analysis!!!
Ok, I am actually very interested to read your thesis when done. This is a topic I think people make too difficult and am curious to see how you do it in 6 months!
ReplyDeleteChris,
ReplyDeleteYou, my boss, and my advisors might be the only people on the planet who are actively interested in this topic.... I'd love to talk to you more about it when I'm done!