theOrko.com

theOrko.comtheOrko.comtheOrko.com

theOrko.com

theOrko.comtheOrko.comtheOrko.com
  • Home
  • Career
  • Education
  • Projects
  • Play
  • More
    • Home
    • Career
    • Education
    • Projects
    • Play
  • Home
  • Career
  • Education
  • Projects
  • Play

Career

Novo Nordisk (formerly Catalent Indiana)

Novo Nordisk (formerly Catalent Indiana)

Novo Nordisk (formerly Catalent Indiana)

 

At Novo Nordisk, I work at the intersection of deviation execution, system design, and cross-functional coordination within a growing quality environment. I approach problems as an engineer, focusing on systems, root causes, and execution constraints across deviation investigations, CAPA development, and process improvement.


I support GMP deviations in close partnership with Manufacturing, Engineering, QC, Facilities, and Leadership, while leading development of a Deviation Execution Visibility system that shifts oversight from static status tracking to real-time constraint intelligence. Built using Smartsheet and Azure dashboards, the pilot improves escalation clarity, protects manufacturing operations, and strengthens cross-functional alignment.


As Novo Nordisk’s quality infrastructure matures, I am focused on building scalable systems that unify execution and analytics, while preparing for future roles in project management and continuous improvement, including pursuing PMP certification.

Kite Pharma (part of Gilead Sciences)

Novo Nordisk (formerly Catalent Indiana)

Novo Nordisk (formerly Catalent Indiana)

At Kite Pharma, a leader in CAR-T cell therapy and part of Gilead Sciences, I was given my first opportunity to fully deploy the systems thinking developed in prior roles. Operating in a fast-paced, high-complexity therapeutic environment, I designed and managed QA database and tracking infrastructures, including Smartsheet-based deviation management systems.


My work focused on improving visibility, prioritization, and workflow control across QA operations—transforming fragmented processes into structured, auditable systems. This role validated my ability to convert executional experience and quality theory into practical, scalable tools that function under regulatory pressure and operational urgency.

Amgen Inc.

One Lambda (part of Thermo Fisher Scientific)

One Lambda (part of Thermo Fisher Scientific)

     My transition to Amgen marked my first formal role in Quality Assurance and   represented a pivotal inflection point in my career. Assigned to grave-shift floor support with my previous leadership experience, I operated as the independent QA representative during active manufacturing operations, serving   as the primary quality authority interfacing with manufacturing teams.

   This role demanded judgment, autonomy, and calm decision-making under pressure. I guided manufacturing personnel through deviation assessments, compliance questions, and real-time quality challenges while maintaining alignment with established quality systems. At Amgen, I gained deep exposure to what mature, well-designed quality systems look like—systems that support people, enable trust, and scale reliably across operations. This experience became a reference model for how I evaluate and design quality frameworks going forward.

One Lambda (part of Thermo Fisher Scientific)

One Lambda (part of Thermo Fisher Scientific)

One Lambda (part of Thermo Fisher Scientific)

     I   began my career at Thermo Fisher Scientific, within the One Lambda   organization founded by immunologist Dr. Paul Terasaki. Entering directly   from university in a foundational manufacturing role, I gained first-hand   exposure to the realities of production, compliance, and execution on the   manufacturing floor.

   Through sustained effort and self-directed learning, I progressed into   Scientist and Product / Team Lead responsibilities, where I was required to   understand the full operational lifecycle—spanning supply chain coordination,   packaging operations, manufacturing execution, engineering interfaces, and   quality oversight. While supporting the SSP product line, I served as a   manufacturing and QA subject-matter expert, contributing to process   development, validation activities (IQ/OQ/PQ), and cross-functional problem   solving.

   In parallel, I invested heavily in Lean methodology, receiving formal   training and serving as a Process Manager responsible for identifying waste,   leading Kaizen initiatives, and implementing continuous improvement   strategies. I led multiple improvement projects focused on efficiency,   compliance, and sustainability. These formative years grounded my philosophy:   theory matters—but only when it is forged through real execution.

Copyright © 2025 theOrko.com - All Rights Reserved.

  • Career
  • Education
  • Play

Powered by

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

Accept