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Senior Associate Manufacturing - Technical Training- Upstream Bulk Drug Substance

Job in Holly Springs, Wake County, North Carolina, 27540, USA
Listing for: Initial Therapeutics, Inc.
Apprenticeship/Internship position
Listed on 2026-09-22
Job specializations:
  • Manufacturing / Production
    Manufacturing & Industrial Operations, Manufacturing Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 85000 - 120000 USD Yearly USD 85000.00 120000.00 YEAR
Job Description & How to Apply Below

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patients drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior

Associate Manufacturing
- Technical Training - Upstream Bulk Drug Substance Live What  you will do

Lets do this. Lets change the world. In this vital role, you will be a key member of the team that develops and facilitates training and the Human and Organizational Performance (HOP) philosophy in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. We are looking for a talented Manufacturing team member to help deliver opportunities for reliability, efficiency, agility and differentiation for the ANC Manufacturing plant.

This individual contributor position reports into the Senior Manager of the MFG Technical Training teamand interacts broadly across the site to implement key training and (HOP) deliverables, quality initiatives. This role will focus on supporting manufacturing training on and off the floor and supporting investigations when necessary. The flexibility tosupport all four shifts covering 24/7 operations is a requirement.

Responsibilities include:
  • Supporting the development and execution of the manufacturing training strategy,ensuring operational readiness and efficient time to contribution.
  • Providing training expertise for MFG area of responsibility (i.e. cell culture, purification, MFG Services).
  • Leading and organizing MFG New Hire Orientation, ensuring content is up to date and relevant.
  • Performing Job Task Analysis on the floorto determine where Performance Supporting Materials (SOP updates, videos, one-slide updates etc.) are needed and then creating Performance Supporting Materials to createabest-in-class training program.
  • Supporting Manufacturing teams during complex investigations and change controls.
  • Use operational Learning Team strategies to promote open collaboration with staff to maximize learning opportunities and investigation findings.
  • Support annual requalification programs for manufacturing to ensure training compliance.
  • Maintain accurate Training Assignment Profiles and Assignment Vehicles for Manufacturing areas.
  • Serve as Learning Management System SME and first stop for questions from MFG staff and management about the training program.
  • Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
  • Build effective relationships across functions.
  • Navigate through ambiguity and provide a structured problem-solving approach.
Win What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications
  • Masters degree
  • OR
  • Bachelors…
Position Requirements
10+ Years work experience
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