Downstream Manufacturing Lead — Night Shift (Biotech)

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

Benefits offered by this job

Flexible work model

Career development opportunities

Competitive benefits

Job summary

Amgen seeks a Manager Manufacturing (Downstream) for the Night Shift to lead on-shift teams in a 12-hour 2-2-3 schedule, supporting 24/7 GMP drug substance production. The role emphasizes safety, Lean practices, coaching staff, and regulatory compliance in a complex biotech plant.

You will partner with QA/QC, F&E, PPIC, and Regulatory to deliver operational goals, drive improvements, and develop talent in a fast-paced environment.

Qualifications

• Doctorate or higher with manufacturing/operations experience as specified in the posting.
• And/or Master’s/Bachelor’s with manufacturing or operations experience and resource leadership.
• Experience directing teams, projects or programs and allocating resources as a manager.
• Strong leadership, biotechnology production operations knowledge and regulatory familiarity.
• Experience in a cGMP environment and downstream purification context.
• 5+ years in a cGMP manufacturing facility; 3+ years in a lead/manager role.

Responsibilities

• Lead on-shift front line management for 24/7 operations on a 12-hour rotation.
• Coach, hire and mentor staff; drive Lean and continuous improvement culture.
• Ensure compliance with cGMP and CFR and maintain safe production environments.
• Oversee cross-functional collaboration with QA/QC, F&E, PPIC, Mfg, PD, Regulatory.
• Develop area objectives, identify improvement opportunities and lead change.

Skills

Manufacturing leadership

Lean manufacturing

cGMP knowledge

Problem solving

Regulatory knowledge

Education

Doctorate or PhD

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Microsoft Office

DeltaV

EBR/MES

Electronic quality systems

Job description

Amgen seeks a Manager Manufacturing (Downstream) for the Night Shift to lead on-shift teams in a 12-hour 2-2-3 schedule, supporting 24/7 GMP drug substance production. The role emphasizes safety, Lean practices, coaching staff, and regulatory compliance in a complex biotech plant.

You will partner with QA/QC, F&E, PPIC, and Regulatory to deliver operational goals, drive improvements, and develop talent in a fast-paced environment.