Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

Amgen; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Annual bonus program

Flexible work models

Job summary

Amgen is seeking a Front Line Manufacturing Manager for their new FleX Batch plant in Holly Springs, North Carolina. In this role, you will lead a team responsible for downstream manufacturing operations, ensuring compliance with safety and regulatory standards. The ideal candidate will possess a relevant degree and significant experience in manufacturing operations, along with strong leadership skills. Amgen offers a comprehensive benefits package and flexible work arrangements.

Qualifications

• Master’s degree and 3 years of Manufacturing or Operations experience.
• Bachelor’s degree and 5 years of Manufacturing or Operations experience.
• Experience managing teams/projects in a manufacturing setting.

Responsibilities

• Lead and develop a manufacturing team and set performance expectations.
• Support design and commissioning milestones for a new manufacturing facility.
• Drive safety, quality, and cost performance across operations.

Skills

Leadership

Manufacturing Operations

Conflict Resolution

Process Implementation

Regulatory Compliance

Education

Bachelor’s degree in Life Sciences or Engineering

Doctorate degree

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Front Line Manufacturing Manager – Downstream Bulk Drug Substance – Days

The Manager Manufacturing Downstream will provide frontline leadership supporting the facility expansion program and facility startup for Amgen’s new FleX Batch plant. The role leads a team responsible for downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill, while partnering across functions to ensure operational readiness, technology transfer, and ramp‑up of manufacturing operations.

Key Responsibilities

• Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
• Support design, build, commissioning, qualification, staffing, training, and readiness milestones for a new manufacturing facility.
• Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
• Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshoot, and continuous improvement.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up.
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Work non‑standard hours as required, including 12‑hour 2‑2‑3 shifts to support 24/7 operations.

Qualifications

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 3 years of Manufacturing or Operations experience OR
• Bachelor’s degree and 5 years of Manufacturing or Operations experience OR
• Associate’s 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 leading teams, projects, or programs, or directing the allocation of resources.

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering
• Experience with facility startup, commissioning, or operational readiness
• Biologics / drug substance manufacturing experience (downstream)
• cGMP manufacturing experience (5+ years preferred)
• Experience with technology transfer and process implementation
• Prior Area Lead / Specialist / Manager experience
• Strong leadership, performance management, and conflict‑resolution skills
• Solid understanding of regulatory requirements
• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

Benefits

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, Stock‑based long‑term incentives, and award‑winning time‑off plans with bi‑annual company shutdowns.
• Flexible work models, including remote work arrangements where possible.