Balancing life responsibilities is not always easy to achieve especially when your goals require sacrificing time from your family. I believe that to be a successful woman one will have to sacrifice something in life. In my case is time with my family. I like to think that I work to live not that I live to work. I love my job, but I love my family even more.
Let me give you some background of how I got my initial experience working in lab. When I was 18, I got my first job in a company that use to make carbon monoxide alarms. I started working in the R&D lab assisting one of the main chemist. My main responsibilities were to run experiments and collect data. The job was easy and entertaining. I really enjoyed working in that type of environment. It gave me confidence and appreciation for science. A few years later a friend told me about an opening they had at his company and so I went and applied and that’s how I got myself into the biotech industry. This was back in 2000 and since then my career took a turn for the best. The company that I got hired was doing great at the time they had recently been granted approval by the FDA to launch what is now one of the most successful drug therapies for Non-Hodge lymphoma (Rituxan). The company offered me the most amazing benefits. I was given all the perks you can imagine such as health insurance; stocks options, Employee stock purchase plan and a 401K plan with 100% matching contributions. I honestly didn’t even know how stocks and shares, or 401K really worked but due to the circumstances I had to learn.
The biotech industry was a great fit for me because I am a very outgoing and enthusiastic individual that is not afraid to speak up in a room full of people. I also like working in teams and that is a must in the industry because making a new drug requires team effort. Working in biotech has allow me to work and collaborate with diverse team members from varied academic backgrounds including biologist, engineers, doctors, scientist, clinicians and many other professionals. Having these types of interactions have helped grow professionally and personally too. In my occupation I have learned many valuable skills and have gain a deep understanding of how the biotech industry works as a whole. I have had the opportunity to collaborate with various departments such as Quality Control, Quality Assurance, Clinical and Regulatory systems, Process Development, Research & Development, Materials, logistics, microbiology, and many more but the point is that I have learned valuable material from each interaction. Therefore, making me want to continue working in the industry.
Another big plus of working in biotech is that you can move around the company and try new jobs and if you have the drive and determination like me then it won’t be hard to move up the ladder to a position of leadership. “Companies like Celgene, Biogen Idec and Gilead Sciences all took top spots on the list of the Best Employers in America. Clearly there are a lot of people who love working in Pharma and biotech (Bussinessinsider.com). Biotech open his doors to me, and honestly, it’s been the best school I have ever had. I am immensely grateful for all the courses, classes and certifications that I have received in my career. All the training provided has really sharpened my skills making me a more valuable employee.
I consider my current job the most exciting and interesting one out of all the ones that I have had. For the last 8 years I have been working in a company called Stemedica Cell technologies. We manufacture adult allogeneic stem cells, (itMSCs) for use in FDA approved clinical trials in the US. Additionally, we supply our stem cells to geographic distributors to conduct clinical trials that are approved by international regulatory agencies” (Stemedica.com). The company is in phase 2 of our clinical trials. There is a total of three phases, so we are getting close to approval. As you can imagine these are very exciting times for the company. Once the required data is gathered from the trials the FDA will decide if the cells are ready for commercial approval. The approval process for any pharma can be tedious and could last many years. The cost of running a licensed facility is very expensive to say the least. The facility must be in a state of compliance because inspectors can show up any time and demand to see company records. If the company is not in accordance with code regulations, we can get cited and eventually shutdown.
I honestly believe that stem cells are the regenerative medicine of the future. “Our stem cells are called itMSCs (ischemia-tolerant mesenchymal stem cells) they work primarily on the environment for healing. Circulating throughout the body and homing to sites of injury, they release proteins and growth factors into the damaged tissue, rescuing damaged cells from death and creating the right conditions for the newly mobilized cells to proliferate and repair. As you can imagine there is so information to be learned.
Additionally, I find this job so ideal because it aligns with my values. I believe in integrity and innovation. I believe that a successful company will help his employees grow and will provide the adequate training for an exceptional performance. A happy employee is a productive employee. The Biotech industry is highly regulated by the Federal Drug Administration (FDA) and many other agencies. Due to the high number of regulations all personnel working in Manufacturing and supporting groups must go thru a lengthy set of qualifications. Each department has their own set of qualifications. All training is documented and mandatory.
One of my favorite responsibilities is to train new personnel. Most of the trainees are newly graduated students with Biology majors. I feel proud and accomplished to know that I am the one training and teaching them how to do cell culture aseptically because there is a difference between doing cell culture in a lab and doing cell culture aseptically under Good Manufacturing Practices (GMP) but what exactly does (cGMP) means in the biotech world. “cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards” (FDA.gov).
As you can see this type of work requires a lot of integrity, multitasking, and a strong technical background. Everything we do has standard operating procedure (SOP) meaning every task has its own set of instructions that needs to be followed at all times and can’t deviate from them or else a report will have to be generated explaining exactly what happened. Every aspect of manufacturing is highly controlled. In the GMP world nothing gets destroy. In the GMP world is illegal for any employee to destroy or to erase data. Each employee working in Manufacturing or supporting departments are required to go thru extensive training to learn how to properly document and fix errors. Anyone that documents something incorrectly in any type of controlled documents is required to follow Good Documentation practices (GDP). All it means is that every error should have a justification and it should be cross out using a single line initial and dated. The message is never to erase, change or obliterate data. This is part of having good documentation practices (GDP).
The work that I do requires a lot of planning and training, so no one is allowed inside the cleanrooms until they have completed a robust set of qualifications. Before anyone is allowed in the cleanrooms (lab) they need to demonstrate they now how to gown properly. All training must be documented or else it doesn’t exist. As you can see working in the industry is not that simple and is not for everyone. However, for me this is not the case. I been doing this type of work for so long that I really don’t see myself doing anything else. The controls in place are many and for good reason. Working in the GMP world can be challenging and stressful at times but I assure you. The job is worth it.
Doesn’t this sound interesting? It does to me and this is one of the many reasons I enjoy working so much in the field. I’m so passionate about my job and I also very lucky to work with a group of very smart people that have become like my second family.
I strongly believe that our jobs are like our second family. We spend more time at work than any other place. Currently, there are 6 people in my group and I am so fortunate to be working with the most amazing and hardworking people. We are a small dynamic group. There is a great chemistry between us and that is such a big part of feeling comfortable at work because if there is tension between the employees is not a healthy environment.
Another reason why I find this job ideal is because I spent 40% of my time in the lab and the other 60% in the office so I get to do a little bit of both. Being surrounded by all sorts of scientist and professionals has given me the motivation to want to learn more. Therefore, I decided to go back to school to obtain my associate in science with an emphasis in Biotechnology. This is going to help me get to the next level. What is more a degree in biotechnology is not restricted to a lab coat. Once you get to know the system there is a wide assortment of professions that one can get into so is not limited to just lab work.
Working in biotech has expanded my views in so many ways. I will forever be grateful to the industry for the many opportunities that I have received. Life has taught me many lessons. One of the most important ones is to never give up. Don’t let anyone tell you that it can’t be done. I know that I can do anything I want if I put my mind into it. Working for a meaningful cause it’s important to me. Knowing at the end of each day that I have contributed to a great cause makes things so much easier.
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