SCIENTIST SPOTLIGHT: October 2018

Name: Zach Dubey
Alcami Site: Germantown, WI

How long have you been with Alcami?
I have been with Alcami for two years.

What is your role? 
I am a Process Chemist in the Kilo Labs Manufacturing department, which manufactures APIs, normally generics, on a smaller scale (gram to kilogram scale).

What is the most rewarding part of your job?
The most rewarding part of my job is training new personnel and collaborating with the Technical Services department on the Kilo Labs processes with which I have become intimately familiar. I also enjoy learning about these processes beyond the executional level (i.e. the sequence of steps in the batch record); understanding the underlying chemistry within these processes provides a greater respect for the chemistry and answers “the why question,” or why I am executing a step—or sequence of steps—a certain way. This has also been beneficial when writing complicated deviations that require a sophisticated understanding of these processes.

What are your team’s latest achievements?
The Germantown site recently hosted a client face-to-face deep dive meeting where we analyzed one of the final product commercial APIs we manufacture in the Kilo Labs. The project team, select members of the Kilo Labs, including myself, and the client’s project team assembled in order to identify potential issues from multiple perspectives; we collaborated on potential solutions to either mitigate or eliminate existing or potential failure modes in order to ensure on-time delivery of the final product API. At the conclusion of the meeting, we came up with several concrete, proactive action items, with many specific to the manufacturing side of the process. We will be running the next campaign later this fall, and I am excited to see the impact of these improvements.

How do you see those accomplishments affecting the pharmaceutical and biotech industries?
With regards to the Kilo Labs, many of the processes we manufacture are considered “legacy products.” These are processes that have been running in the Kilo Labs for over a decade in some cases (and are typically commercial APIs which have become generic). Completing deep dive meetings such as these continues to show that even if a process is “well understood,” there are still ways in which we can improve them. Alcami’s initiative for continuous improvement and optimization of manufacturing processes, whether legacy or brand new, demonstrates Alcami’s dedication for improving product quality and passion for customers.

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