Bulk Drug Substance Manufacturing Leader - Startup & 24/7

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Flexible work arrangements

Job summary

Amgen in North Carolina seeks a Front Line Manufacturing Manager for Bulk Drug Substance Services to provide frontline leadership for the facility expansion, startup, and ongoing operations. You will oversee teams handling materials, weighing, buffer/media prep, parts washers, and autoclave processes to ensure readiness and compliant production.

The role covers startup, technology transfer, and ramp-up with a 12-hour 2-2-3 shift during 24/7 operations; occasional nonstandard hours and holidays

Qualifications

• Doctorate degree OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Bachelor's degree and 5 years of Manufacturing or Operations experience OR
• Associates degree and 10 years of Manufacturing or Operations experience OR
• High school diploma / GED and 12 years of Manufacturing or Operations experience
• AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

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.
• CrossFunctional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.
• Compliance & Inspection Readiness: Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Continuous Improvement: Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Shift Support: Work nonstandard hours as required, transitioning to a 12hour 2-2-3 dayshift supporting 24/7 operations.

Skills

Leadership

People management

Project management

Quality systems

Regulatory compliance

Communication

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Amgen in North Carolina seeks a Front Line Manufacturing Manager for Bulk Drug Substance Services to provide frontline leadership for the facility expansion, startup, and ongoing operations. You will oversee teams handling materials, weighing, buffer/media prep, parts washers, and autoclave processes to ensure readiness and compliant production.

The role covers startup, technology transfer, and ramp-up with a 12-hour 2-2-3 shift during 24/7 operations; occasional nonstandard hours and holidays