Frontline Drug Substance Ops Manager (Flexible Work)

BioSpace; Holly Springs (NC); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Benefits package

Bonus program

Stock incentives

Flexible work model

Retirement savings plan

Job summary

Amgen is seeking a Front Line Manufacturing Manager to lead a manufacturing team at the new FleXBatch facility in North Carolina. You will drive frontline operations, safety, quality, and readiness as we expand capabilities for 24/7 production.

The role covers design, startup activities, process transfer, and continuous improvement. Candidates should have strong leadership and cGMP experience in a high-paced manufacturing environment.

Qualifications

• Advanced degree(s) in Life Sciences or Engineering preferred.
• Experience leading manufacturing/operation teams in cGMP environments.
• Ability to manage multiple priorities and drive schedules.

Responsibilities

• Lead, develop, and coach a manufacturing team with a strong safety, quality, and accountability culture.
• Support design, build, commissioning, qualification, staffing, training, and readiness milestones for a new facility.
• Ensure safe, CGMP-compliant execution and drive performance in safety, quality, schedule, and cost.
• Support transfer and implementation of manufacturing processes; enable troubleshooting and continuous improvement.
• Collaborate across Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership for startup and ramp-up.

Skills

Leadership

Team management

Manufacturing

Education

Doctorate

Master's degree

Bachelor's degree

Associates degree

High school diploma

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Amgen is seeking a Front Line Manufacturing Manager to lead a manufacturing team at the new FleXBatch facility in North Carolina. You will drive frontline operations, safety, quality, and readiness as we expand capabilities for 24/7 production.

The role covers design, startup activities, process transfer, and continuous improvement. Candidates should have strong leadership and cGMP experience in a high-paced manufacturing environment.