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Front Line Manufacturing Manager - Downstream Bulk Drug Substance

Job in Holly Springs, Wake County, North Carolina, 27540, USA
Listing for: NCBiotech
Full Time position
Listed on 2026-09-28
Job specializations:
  • Manufacturing / Production
    Manufacturing & Industrial Operations, Operations Management, Pharmaceutical Manufacturing, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 106148 - 143612 USD Yearly USD 106148.00 143612.00 YEAR
Job Description & How to Apply Below

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experience,and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide.

Come do your best work alongside other innovative, driven professionals in this meaningful role.

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 disposable 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.

Front Line Manufacturing Manager
- Downstream Bulk Drug Substance
- Days

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Manager Manufacturing Downstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing downstream purification operation s including column packing, c odor chromatography, TFF, v iral f iltration, v iral i nactivation, conjugation, and final fill while partnering across functions to ensure successful operational readiness, technology transfer, and ramp‑up of manufacturing operations within the new facility.

The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5pm.

This role may require work outside standard business hours, including non‑standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

Responsibilities
  • Frontline Leadership: Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
  • Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
  • Manufacturing Operations: Ensure safe, cGMP-compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
  • Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
  • Cross-Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up.
  • Compliance & Inspection Readiness: Maintain…
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