An overall positive experience - Deviation Writer INCOG BioPharma Services Employee Review

Excellent management, beautiful facility, great pay

Open concept office area is not the easiest to work in.

INCOG has a state of the art facility with best in class equipment. Everything is new and shiny which looks great. There is always sparkling water and snacks around, and the company tries to put on events that are fun. There are EV chargers. The break room overlooks a patio and a pond. At first glance, it’s a nice, comfortable work environment. The existence as such is not at all like the essence. If you have audit response expertise and know how to navigate low integrity regulatory compliance environments with stubborn managers, there is a real opportunity for you. If you want to work at INCOG you must be aligned with the tiny like minded leadership team and not go against the grain. If you’re a deferential person who doesn’t stand out in a crowd, can overlook decisions that cost later for the sake of allegiance to the hierarchy, you’ll do great here. The pay is competitive, benefits are very bad, culture is rife with unfairness throughout. If you know how to stay on the better side of that, you’ll be just fine. Leadership is a homogenous cis straight good ol’ boys club, they only let people aligned with the same agenda elevate. If you know how to beat this game, it could be great for you. If you know how to scaffold an upward trajectory in a run of the mill corporate motif with a room full of main characters, there is opportunity in learning to navigate it.

It took me a while to figure out what was wrong with the organization, and why their batch release times are abysmal. As I began my work as an end user of INCOGs quality systems I discovered a hair raising amount of human error and blame shifting throughout INCOGs problem solving. Most of its leaders come from a recently acquired site in Bloomington with a very bad quality record, and whose most recent 483s made headlines. Not just for the deviations themselves but the lack of root cause analyses and under triaged investigations. After learning this, INCOGs quality made a lot more sense. The quality department is run by manufacturing. That’s why most of their quality events have outrageous closure times. INCOGs QA Operations are largely a cosmetic presence as many of the personnel are severely under qualified. Most of the managers have no science background and/or expertise making medicines. On top of that, they are surprisingly resistant to change despite claiming to champion “innovation.” I figured out this stems from the top. The CEO has no science education, and is mimicking other business magnates using aseptic manufacturing as fodder for business arbitrage with little concern for the patients that need these medicines. As a result they allow human error based thinking to be an anathema to Kaizen. ALCOA++ is not a thing there and metadata is often not representative of the underlying data used to create it. The manufacturing managers lean on quality event authors to soften language, to sanitize reports leaving them bereft of the technical muster they require to prevent recurrence. The goal of INCOG is short to medium term expansion of the business ecosystem so that it’s ripe for a sale. That’s why there is no true QA Incoming or QA Batch Release, and most of the people approving investigations have little to no science education or training. Manufacturing leaders don’t allow the quality unit to adequately accept or reject process decisions. Moreover, the engineers are decoupled from validation and there is no quality voice questioning the validity or justification for manufacturing decisions. In terms of quality, it will push your melon back. Everyone is too afraid of getting let go to stand up for the patient. My final assessment is those aren’t business priorities because the goal is a sale and not longevity. Friends of the CEO build pharma companies up and sell them all the time. The perversion of the business debts is his business, pharma is just the modicum which is interchangeable. He will tell you himself he was going to start a chain of Taco Bell’s before finding private funds for INCOG and he runs it as such. As soon as the company went black he went and asked more private equity for another 9 figure sum (public info see the press release); the business is run on debt. That means less capital expenditure on quality infrastructure because the goal is physical infrastructure. That means you can expect him to ride away on his golden bicycle when regulatory pressure to ameliorate deep seated quality issues mount beyond what he’s willing to spend to fix them.