Amylin pharma san diego
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Immediate manager was a suck up. Indeed Featured review The most useful review selected by Indeed. The company as a whole was great to work for until we got a new manager. I was hired onto second shift which covered part of first and for manufacturing, which was on a 12 hour shift part of second.
We worked Monday through Friday, PM with periodic overtime opportunities, which was great! We had a great super who, of course got promoted. His replacement was someone who had not worked in our area before and was ok at first. She then decided to move us to 3rd shift by having the full-time employees vote only a third of the group was actually employed by Amylin, the rest were full time contractors. I tried to get the group to push back because the majority did not want to work third shift, and got written up.
Was this review helpful? Report Share. Best start up I've ever worked for. There was no jumping thru hoops like big pharma to get things approved. If it was a good idea you would just make a phone call which gave Amylin the upper hand.
Pros excellent company culture. Cons bought out by larger pharm company. Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document. Job seekers rely on your experience. It felt good to work in company that had a positive impact on peoples lives diabetes research. The leadership team was very technically savvy, which made working IT interesting as we were constantly deploying the latest technologies.
Immediately upon learning of the existence of the Byetta tQT study, the FDA contacted Amylin and asked for the data to be included in the Bydureon resubmission. Instead, Amylin submitted the Byetta tQT study data separately as an addendum to the original Byetta regulatory file.
On Oct. If the study demonstrated a clean heart-safety profile for Bydureon, Amylin could resubmit the drug for review. This study was completed back in So, they certainly were reviewing it. However, we were not aware that this was an approvability issue until we received the complete response letter last night. It was requested by another agency for us to complete, and we did that for them. It is now, I believe, a requirement. This is part of the evolution of the increase in focus on cardiovascular safety for all medicines, particularly those in diabetes.
Had the FDA been aware of the study at the beginning, it would have almost certainly been raised as an issue by U. Bradbury also ignores the fact that the FDA very much wanted to see the Byetta tQT study in order to fully assess the safety of Bydureon. In early November , two weeks after the FDA rejected Bydureon, Amylin held its regular third-quarter conference call.
According to a transcript, one analyst on the call prefaced his questions to Amylin executives with a note of thanks to how they handled the Bydureon setback. Thanks for all the disclosure. I think I speak for everybody, you guys handled this well. We appreciate it. We remain confident in the data supporting Bydureon as the first and only once weekly treatment to be approved by the FDA for the treatment for type 2 diabetes.
The final knockout? San Diego scientists are working on a vaccine against all coronaviruses. Yes, all of them. Offshore wind. Are these the next power resources for San Diego County?
Opportunity to make history with development of three new first-in-class compounds for the management of diabetes. Excellent research department. Competition was fierce in this period of development. Small company by comparison to other pharma giants, with a unique culture. Pros Diverse medical affairs team. Cons Did not take a couple molecules through the research necessary to prove their full potential. This was a typical Pharmaceutical Company.
The majority of the management team were wonderful, and generally travel was kept to a minimum. There is programming which required some evening hours. Amylin was an exciting place to work and we delivered products that made a meaningful difference in the lives of those with diabetes.
Amylin was where my medical writing vocation took form. The training was excellent and there was a strong sense of group within the writing group. Our products addressed the needs of people with diabetes and our work to write about those products touched the MD, the researcher, and the patient. At Amylin, I sold many first in class products that were amazing.
The complete experience was a plus. The management team as well as upper Management were on the same page. It really was a shame that they sold the company! I would have retired there. Pros The Products and the People. Cons That they sold the company. Amylin was a small biotech company where everybody seemed to matter, in a way. It was absorbed by AstraZeneca and of course, all the small company dynamics were lost.
AZ, however, is not a bad place to work. Just typical big-pharma. I would recommend AZ for someone not looking for small company dynamics. Great Company, Great People Sr. After 10 years of service the company has been a great place to work. The people is what made Amylin the place to work in San Diego. It was a great company to work for. Handled travel for the sales force and marketing teams. Worked with great people.
Most of the bosses I had didn't know anything about travel, so it made it hard some times. Pros Good office to work at. Cons Boss not knowing anything about travel. I couldn't have picked a better company to jump into the pharmaceutical industry with. My boss walked beside me every step of the way and the company had an abundance of methods and teaching applications to get me started.
Everyone I worked with had a great attitude which spoke volumes to me about the company I was welcomed into. I enjoyed traveling with the company and felt like I was just as important being the newbie as was the longest employed person on our team. Pros Resources to teach new skills. Cons Position was not guarenteed. Amylin was a young and dynamic company when I worked for them. This was a submissions management position. I created and archived submission documents.
I attended project team meetings and represented the submissions group. Good Place to work.
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