Ravi Garcia Rdg88 Biological Engineering Johnson and Johnson Spring-Summer Co-op Job Summary I did my co-op at Janssen Pharmaceuticals, the

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1 Ravi Garcia Rdg88 Biological Engineering Johnson and Johnson Spring-Summer Co-op Job Summary I did my co-op at Janssen Pharmaceuticals, the Pharmaceutical subsidiary of Johnson and Johnson. Within Janssen, I worked in the Pharmaceutical Development and Manufacturing Sciences (PDMS). The role of PDMS is to take newly discovered drugs of interest and develop the processes necessary to produce the drug to start clinical trials. For large molecule pharmaceuticals (such as antibodies), this involves culturing cells to create the compound, purifying the target compound, making sure that the compound is stable, and creating a formulation for the administration of the drug. Within PDMS, I worked in a group called Strategic Operations. Strategic Operations essentially works to streamline the entire operation within PDMS. My group worked mostly on making data from scientific experiments more accessible to the scientists. I became an expert in the program Pipeline Pilot, a data management software. Right now, scientists in PDMS document their experiments in an Electronic Lab Notebook (ELN). Although one can search for a certain experiment within the ELN, it is impossible to trend data across experiments and create automated reports off of experiments within the framework of the ELN. One of my main projects was creating an efficient, reliable, and automated way to extract data out of the ELN. I did this by directly querying the database tables where the information in the ELN is stored using SQL statements embedded in a Pipeline Pilot protocol. In the end, the protocol I wrote would extract metadata on each experiment, each material used, each piece of equipment used, and each preparation made in an experiment. With standardized data coming out of the ELN, I was able to create tools that helped visualize the data within the ELN. One of my early projects was the Timely Review Protocol. This protocol has a web-based interface that allows users to choose a group, creator, and date. The protocol then sorts through the ELN metadata and creates an organized report showing experiments created before the input date by the input creator that have not been reviewed. Scientists in groups across PDMS opted to use this tool, and it has helped them reduce their compliance risks. I also wrote protocols that used the ELN metadata to create reports that provided basic statistics on ELN use. For example, it would trend the number of experiments created and the number of active users over time. It would also show this information broken down by site. This was helpful for the business owners of the ELN and for the IT department as they are constantly trying to improve the performance of the ELN. Another large effort was for the creation of recipes off of experiments. Recipes are essentially standardized ways of recording information in a structured format. I wrote protocols that used the ELN metadata extracts to create a standardized output that could be loaded into a database called the recipe warehouse. In order to do this, I had to work with the scientists in the Analytical Development group to create standardized excel documents for each analytical method. With the new standardized templates, the data will consistently be in the same place, which makes it extractable through Pipeline Pilot. My recipe writing protocol pulled experiment metadata from the nightly extract, pulled

2 results from these standardized excel files, translated it into recipe format, and outputted it in a format that could be uploaded to the recipe warehouse. This will hopefully allow powerful data visualization of experiment data and will aid in future trending efforts of results across many different experiments. I also wrote protocols that helped scientists easily visualize the output of their mass spec experiments, protocols that helped ensure that employees at the manufacturing plant were up-to-date on their training, protocols to help IT diagnose and improve performance issues in the ELN, and performed maintenance on protocols created by previous employees. Outside of my formal work assignments, I was active in the Intern and Co-op Association (ICA); for the majority of my co-op I was the president. The ICA served as a resource to answer questions that co-ops might have, especially with the onboarding process when they first start. The ICA also hosted social events to promote community amongst the co-ops and career-development events. During the ICA Career-Development fair, we talked with many full-time employees about their career paths and decisions. We got a chance to talk to hiring managers about how to best present yourself when applying for jobs, and we talked with the head of PDMS about how business works at a corporate level. On the whole, my experience at Johnson and Johnson was very positive. Everybody that I worked with was very friendly, enthusiastic to help me out, and willing to answer any questions that came up. I believe that I was an asset to my supervisor and my group, and I am grateful that I had the opportunity to work here.

3 Huang 1 Dantong (Danielle) Huang Net ID: dh373 Major: Biological Engineering Employer: Pharmaceutical Development & Manufacturing Sciences (PDMS), Johnson & Johnson Term 1: Fall 2012 Cornell Engineering Co-op Job Summary: From mid-august 2012 to mid-january 2013, I did my co-op in the Characterization group under Analytical Development, Pharmaceutical Development & Manufacturing Sciences in Janssen Biotech. The Characterization group is responsible for analyzing the primary structure, higher order structure and degradation pathways of monoclonal antibody therapeutics. It supports those drugs that have already moved out of discovery to clinical trials or the market. The group also develops new analytical methods for the analysis of protein therapeutics and responds to questions from regulatory agencies (such as the FDA). During my time here in the Characterization group, I was assigned a specific project to explore a range of protein separation techniques, then identify and develop a method for detecting the oxidation level in monoclonal antibodies. The current peptide mapping method used in our group is very labor intensive, so the goal of my project is to develop a generic, quick and robust oxidation assay that can be used for all of our antibody products. Using High Pressure Liquid Chromatography (HPLC) and mass spectrometry (MS) techniques, I explored three different methods for the separation of oxidized immunoglobulins from native ones. I succeeded at developing a method that can monitor the oxidation level in all of our products, and it is also quick, easy and cheap. I tested and optimized all the parameters of this method, which can also be transferred to other departments. We are also planning on publishing a paper on our method (s). I was assigned a mentor, who trained me on techniques that were used in the lab and gave me valuable guidance throughout this project. He helped me with finding recourses, and I also did online research myself and read a lot of scientific journals. We discussed different approaches to solve the problem and decided on directions to pursue. And then, I would do the experiments, analyze the data, then report and discuss my findings with my mentor at the end. Everyone else in the group was also very friendly and helpful when I approached them with questions. This job definitely relates to my studies in Cornell. I am a biological engineering major and I had always wanted to work in a pharmaceutical or biotechnology company before this coop. Through my work here, I have found that a strong background in biochemistry is necessary, and I could always relate many scientific principles in my work to what I have learned in classes. Analytical and critical thinking skills are also very important. As an engineer, I have found that much of method development starts with engineering thinking that we were trained to have, as it is important to consider all the parameters, factors, resources and costs.

4 I lived at home in the summer and since I did not have a car, I had to rely on public transportation. Fortunately, Regeneron provides free shuttles to two rail lines (the Harlem and Hudson lines). My parents dropped me off at the train station every morning, I took the train down to North White Plains, and then I took the Regeneron shuttle to work. It was a long commute each way and it was very tiring for me. But it was also nice to live at home for one summer since I had not been home for more than a week for a very long time. For future interns and co-ops who have to relocate, I would recommend looking for housing in the New York City or White Plains areas. Many full-time employees live in NYC as well. And public transportation in the area is pretty good since it is very close to the city. Regeneron had many interns in the summer and different activities planned for us. There was a mandatory intern meeting every week, with team building exercises as well as different talks geared toward undergraduate students. I had met other interns and became good friends with the PMPD interns. One of the best features of my co-op is the unique culture of Regeneron. In contrast to the Big Pharmas, Regeneron has a strong focus on research. It is expanding quickly in recent years. In addition, the employees are treated very well, and they are happy and proud to work here. The worst feature of my co-op was transportation. I had to get up very early for the long commute and I would always get home late, so I could not really do anything else after work. Regeneron does not participate in Cornell s regular co-op hiring program, but it does hire co-ops. So for students who are interested in working in biopharmaceutical companies, definitely reach out!

5 Tanvi Nayak Major: Chemical Engineering, Class of 2014 Net-ID: tgn5 Employer: Johnson & Johnson, PDMS, Clinical Supply Chain Term: Fall 2012 Supervisor: Lisa Wu Location: Malvern, PA During my first 4 month rotation as a co-op, I worked with the Clinical Supply Chain Team and was based in Malvern, PA. My supervisor, Lisa Wu, works under the Strategy & Technology sub-team and therefore my various projects dealt with the different tools measuring the progress of all the J&J clinical trials. The main objective of my many projects was to provide an insight into the successful dose tool, kit scrap tool, drug product scrap tool and financial data reports. One of my projects dealt with an evaluation of tools ability to display all the necessary information for the clinical trials. The dashboard I created is a process that evaluates the strengths and weaknesses of the tools on a regular basis. Since this is an ongoing process, I was responsible for streamlining this process, creating an instruction manual and resolving any issues before the end of my term. Another one of my project demonstrated an improvement in capacity of the successful dose tool and kit scrap tool by comparing the trials that started in 2011 to the trials that started in I also worked towards streamlining this process. In addition to these two projects, I also finished working on linking kit scrap to drug product scrap to provide an end-to-end perspective of the clinical trials. In order to do this, I examined the multiple trials for one large and one small molecule. In order to deliver this project, I integrated data from four different systems. I also got an opportunity to work with financial data regarding the clinical trials and got a chance to integrate this information to my previous projects in an effort to improve my earlier processes. I also got a chance to help out with other smaller projects. Since my projects required me to obtain different information, I got a chance to interact with a wide range of people in the Clinical Supply Chain. My supervisor, Lisa Wu, was great at giving me the opportunity to present my information through many different forums and many different meetings. I participated in programs that helped me to connect to various Johnson & Johnson employees in Beerse and Canada to learn about their jobs and tasks. I was also given trained and tested on Excel and waste reduction, pertinent to the Clinical Supply Chain. Many of the other trainings regarding company policies were delivered via an online system. Since I was given many different projects, I was able to develop skills to approach many different employees throughout the organization. One of the best things was that Lisa Wu provided me with many platforms to present my work which helped me improve my presentation skills. The diversity in my projects was the best feature and also the most challenging aspect of this job and it pushed me to continuously learn about the many different tools. Although my background is in Chemical Engineering and I was unable to use many of the basic chemical engineering skills, I really enjoyed contributing to the Clinical Supply Chain department and can envision myself working in a similar department. I have truly enjoyed my work experience at Johnson & Johnson and definitely recommend other Cornell students to apply.

6 As a communications chair for the group Intern/Coop Association (ICA), I was responsible for regularly connecting all the Johnson & Johnson co-ops in the Pennsylvania area through networking and social events. I managed and updated the ICA website and also created and edited the ICA Newsletter (December 2012 edition) to provide our supervisors a platform to understand the ICA s accomplishments. As part of the PDMS division of J&J, I was invited to many activities to understand the status of the department in the current industrial environment and it also gave me an opportunity to network. For example two of the bigger events were a picnic and an end-of-year celebration for all of the US-based PDMS employees. In addition to these huge events, I was also invited to smaller events dedicated to members in the Clinical Supply Chain team. I believe that the length of the co-op provided me an opportunity to create a strong networking connection in comparison to an internship. I am extremely happy that I got to work with the Clinical Supply Chain team and the opportunity to come back and work in the summer of 2013 will be even more rewarding and exciting. I had an amazing experience and I could not have asked for a better supervisor. Although my work experience was very rewarding, I had issues with my housing during my first coop term. I was initially living in Phoenixville, PA, however I had to vacate my apartment due to bedbugs and had to contact health authorities. The landlord I had to deal with was very stubborn and reluctant to admit this problem and it took her two months to finally return my $500 deposit after many discussions. My colleagues and especially my supervisor, Lisa Wu, helped me a great deal during my relocation process. One of my co-op friends agreed to let me stay with her in her huge one bedroom apartment in a professional housing complex in Malvern, PA. My colleagues provided me with assistance to shift my belongings to my new residence. Even though transitioning from one place to another was very stressful, it was amazing to see how quickly I was able to form a support group in a new environment and with new people. The culture that Johnson & Johnson cultivates is truly amazing and I am honoured to be a part of this amazing culture. As I do not have a driving license, I used public transportation to get to and fro work. Although public transportation is not always safe and reliable, I managed to get to work on time and to get home at a reasonable time. I would recommend future co-ops to invest in a car or car-pooling options.

7 Tanvi Nayak Major: Chemical Engineering Net- ID: tgn5 Employer: Johnson & Johnson Term: Summer 2013 Location: Malvern, PA During my second term as a co- op, I worked with the Clinical Supply Chain Team on the Integrated Planning and Forecasting Project and it was based in Malvern, PA. My supervisor, Charlotte Herscher, was the project s manager. Since the Integrated Planning and Forecasting Project is aimed towards shifting the clinical supply chain team towards the new planning and scheduling system, my projects were all aimed towards supporting change management. One of my overall goals was to provide support to help facilitate the transition process to the new planning and scheduling system. One of my projects dealt with writing unit test scripts to accurately and efficiently translate the business processes to the system processes in the new planning and scheduling system. This required me to understand the business process, understand the new planning and scheduling system and be able to discuss with the respective business owner to be able to conduct and write a detailed unit test. I was quickly able to operate the new planning and scheduling system and I was able to become a super user of the development environment of the planning and scheduling system. Another one of my projects dealt with leveraging data transfer from the various programs to the new planning and scheduling program. It also required me to report to the group the required format of the data and the various systems that would determine the format. Another one of my projects dealt with attending meetings that dealt with redefinition and outlining of work instructions and responsibilities of each role in the team to help facilitate transition to the new planning and scheduling program. I was assigned to go through the work instructions to list the various definitions between each work instruction to help create uniformity across the board.

8 I also worked closely with a range of members in the Integrated Planning and Forecasting Project and was able to address the different stakeholders needs in my unit tests. This evolving environment encouraged me to develop an ability to work in uncertain circumstances and develop an ability to take calculated risks. I built a great networking system and received a positive review of my contribution. Housing was set up at a professional location. The rent was subsidized and therefore it was very affordable. We were treated to a very beautiful suite and I was paired with three other roommates. Living with people my age made my life outside my co- op very enjoyable and we explored the Malvern area together.