Senior Manufacturing Programs Leader – Biotech Ops

Biopharma Careers; Holly Springs (MS); On-site; USD 154,000 - 209,000; Full time

Benefits offered by this job

None specified

Job summary

Amgen is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This role provides technical process stewardship, governance, and change control support across Upstream, Downstream, and Services Drug Substance Unit Operations.

The team partners with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing to ensure compliant, efficient operations.

Qualifications

• Doctorate degree and 2+ years biotech/pharma experience
• Master’s degree and 6+ years biotech/pharma experience
• Bachelor’s degree and 8+ years biotech/pharma experience
• Associate’s degree and 10+ years biotech/pharma experience
• High school diploma / GED and 12+ years biotech/pharma experience

Responsibilities

• Lead and develop the Process Owner organization responsible for technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
• Provide direct management, coaching, mentoring, and career development for Process Owners.
• Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.
• Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
• Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation, manufacturing procedures, CAPAs, and technical stewardship.
• Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance.
• Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.
• Oversee execution of dry runs, water runs, engineering runs, and operational readiness activities.
• Own manufacturing-related CAPAs and change controls for process, procedures, and improvements.
• Provide leadership for EBR and MES implementation activities impacting manufacturing operations.

Skills

Leadership

Process ownership

GMP manufacturing knowledge

Digital manufacturing systems

Manufacturing support

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Electronic Batch Records (EBR)

Manufacturing Execution System (MES)

Job description

Amgen is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This role provides technical process stewardship, governance, and change control support across Upstream, Downstream, and Services Drug Substance Unit Operations.

The team partners with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing to ensure compliant, efficient operations.