Complete Employee Disaster

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You live and you die by the money in the CMO/CRO world. As long as the ELT gets close to the revenue goals they will be here. If and when they miss for a few months or quarters then ARES will replace them. Until a new a-hole come in we are stuck with the a-holes we currently have. As the ELT team likes to say "shut up"
 






anonymous said:
You live and you die by the money in the CMO/CRO world. As long as the ELT gets close to the revenue goals they will be here. If and when they miss for a few months or quarters then ARES will replace them. Until a new a-hole come in we are stuck with the a-holes we currently have. As the ELT team likes to say "shut up"
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This isn't about making money in the short term , this is about sustainability. The situation across stes is deteriorating, and this spring looks to be a repeat of last year's exodus.
The ELT's tactics are not going to allow for sustainable growth, if simply due to availability of a trained work force. I have personally witnessed dozens of people leaving in the past two years. At some point there will be a massive accident or customers/FDA will discover the effects of the high turnover. It is as simple as that.
 






The job market is very competitive, people can easily get work elsewhere. The fact that they treat us badly just shows how clueless these clowns that run the place are....vote with your feet and leave the syncophants and snakes in suits behind.
 






anonymous said:
The job market is very competitive, people can easily get work elsewhere. The fact that they treat us badly just shows how clueless these clowns that run the place are....vote with your feet and leave the syncophants and snakes in suits behind.
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The assholes with the colorful socks, as they are known. The old farts never caught on, just tend to overuse the cologne. They never smile.
They are all so self important and use big words. They repeat the same shit every time. People know they are being watched, what a joke anymore.
 






The messed up thing is that it is hard seeing things get better. Hope has been trashed over and over. For those of us stuck where we are geographically there aren't a lot of options, although a few people have spoken to just walking out. BTW not sure if this is true but the production guys do get an occasional day off and even get sick days. That said, they are motoring through people too. Most of the engineers will put in 18 months and start looking, watch.
 






anonymous said:
The messed up thing is that it is hard seeing things get better. Hope has been trashed over and over. For those of us stuck where we are geographically there aren't a lot of options, although a few people have spoken to just walking out. BTW not sure if this is true but the production guys do get an occasional day off and even get sick days. That said, they are motoring through people too. Most of the engineers will put in 18 months and start looking, watch.
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If the numb nuts that run this dump can get 18 months out of an employee then they are HAPPY. That is a success story! This is a crap company, the days of an employee working here if 10-15 years, being appreciated, promoted and being happy are long gone. Only the weak, foolish or trapped remain.
 






Such a sick bunch of sociopaths run this cluster fuck. What a shit show. The investment Ares made is being pissed away by these clowns. A 483 and a warning letter are just the start for Alcami
 
























483's are nothing new, it appears allcrappy gets one every time the FDA visits.

FEDZILLA has 483 being issued in 2013 (Germantown), 2016 (Wilmington, Germantown, Edison all got a 483) and 2017 (Charleston and St Louis both got 483s).

Go team
 






anonymous said:
483's are nothing new, it appears allcrappy gets one every time the FDA visits.

FEDZILLA has 483 being issued in 2013 (Germantown), 2016 (Wilmington, Germantown, Edison all got a 483) and 2017 (Charleston and St Louis both got 483s).

Go team
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The ELT & Fearless Leader tells us that it's due to the auditors getting up on the wrong side of the bed. No big deal.
Maybe Little Stevie should introduce himself to the FDA and lend a hand,
 






Bull. FDA auditors are professionals and if a 483 is issued it is for cause. If the company does not implement an effective corrective action then another 483 or a warning letter will be issued.

The fact that allcrappy is a CMO just raises the stakes. SK can attest to this, ask him about Tercica and Eisai and what happened to them when he was in charge of their manufacturing projects.
 






anonymous said:
Bull. FDA auditors are professionals and if a 483 is issued it is for cause. If the company does not implement an effective corrective action then another 483 or a warning letter will be issued.

The fact that allcrappy is a CMO just raises the stakes. SK can attest to this, ask him about Tercica and Eisai and what happened to them when he was in charge of their manufacturing projects.
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That's all water under the bridge. Allshitty takes the time to keep their kwality systems strong and it's people happy.
Hahahahahahahaha!
 






It can happen here too...same management at a different CMO

"French drugmaker Ipsen ($IPN) says supply interruptions of its orphan drug Increlex appear inevitable because of ongoing issues at a Lonza API plant in Hopkinton, MA, which is the subject of a 2011 warning letter. The drug is used to treat IGF-1 deficiency, a rare condition in children, which results in them being very short for their age. Ipsen said last week that doctors and patients can expect supply interruptions to begin appearing in the U.S. immediately and in Europe and the rest of the world by the third quarter. It said Lonza is working closely with the FDA "to address these issues," but that it did not expect the supply problems to be resolved before the end of this year."
 






Same crappy quality at a different CMO...first a 483, then a warning letter and then the plant closes.

"Lonza has received an FDA warning letter following cGMP violations in the production of Eisai's Ontak at its Hopkinton, MA, facility. Lonza received the letter after failing to address issues raised in inspections during April and May. The FDA cited Lonza for inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards; failure to validate analytical test methods used for API for potency testing; and failure of its quality unit to exercise its responsibility to ensure that APIs manufactured are in compliance with CGMP, including meeting established specifications for quality and purity."
 






Same crappy quality....first a 483, then a warning letter and then the plant closes

“Lonza has received an FDA warning letter following cGMP violations in the production of Eisai's Ontak at its Hopkinton, MA, facility. Lonza received the letter after failing to address issues raised in inspections during April and May. The FDA cited Lonza for inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards; failure to validate analytical test methods used for API for potency testing; and failure of its quality unit to exercise its responsibility to ensure that APIs manufactured are in compliance with CGMP, including meeting established specifications for quality and purity.”
 
























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