Night-Shift Upstream Manufacturing Manager (Bulk Drug Substance)

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Career development

Inclusive culture

Total rewards

Job summary

Amgen is seeking a Manager Manufacturing (Upstream) - Night Shift to lead a team on the FleX Batch facility in North Carolina. You will oversee GMP drug substance production, drive safety and compliance, and champion Lean continuous improvement on the production floor.

You will supervise, coach, hire and develop staff, define objectives, and coordinate with cross-functional teams to meet short- and long-term operational goals in a high-regulation, fast-paced environment.

Qualifications

• Doctorate degree OR
• Masters degree with 3 years of Manufacturing and/or operations experience OR
• Bachelors degree with 5 years of Manufacturing and/or operations experience OR
• Associate degree with 10 years of Manufacturing and/or operations experience OR
• High school diploma / GED with 12 years of Manufacturing and/or operations experience AND prior managerial experience

Responsibilities

• Be the on-shift front line manager in manufacturing.
• Lead a team of experienced manufacturing associates responsible for GMP drug substance production.
• Champion a safe and compliant production environment and Lean culture on the floor.
• Supervise, coach, hire and develop floor staff.
• Define area objectives and drive improvement opportunities on the manufacturing floor.
• Collaborate with QA/QC, F&E, PPIC, Mfg, PD, Regulatory and others on production activities.

Skills

Leadership

Team management

Lean manufacturing

cGMP compliance

Regulatory knowledge

People development

Problem solving

Project management

Communication

Budget planning

Education

Doctorate degree

Masters degree

Bachelors degree

Associate degree

High school diploma

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic quality systems

Job description

Amgen is seeking a Manager Manufacturing (Upstream) - Night Shift to lead a team on the FleX Batch facility in North Carolina. You will oversee GMP drug substance production, drive safety and compliance, and champion Lean continuous improvement on the production floor.

You will supervise, coach, hire and develop staff, define objectives, and coordinate with cross-functional teams to meet short- and long-term operational goals in a high-regulation, fast-paced environment.