Remote-friendly Frontline Upstream Biotech Manager

BioSpace; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Front Line Manufacturing Manager - Upstream Bulk Drug Substance in North Carolina to lead an expanding facility startup and ramp to 24/7 operations. You will oversee a cell culture manufacturing team, drive readiness, and coordinate across Quality, Engineering, and NPI to ensure compliant, efficient production.

The role requires a strong background in cGMP manufacturing, technology transfer, and people leadership, with Monday–Friday start and eventual 12-hour shifts.

Qualifications

• Doctorate degree or Masters degree with manufacturing/operations experience, or Bachelors with experience, or Associates with 10 years in manufacturing/operations, or High School with 12 years in manufacturing/operations.
• AND Previous managerial experience directly managing people and/or leading teams, projects, programs or directing resources.

Responsibilities

• Lead, develop, and coach a manufacturing team to meet safety, quality, schedule, and cost goals.
• Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new facility.
• Ensure safe, cGMP-compliant execution and drive performance across safety, quality, schedule, and cost.
• Support transfer and implementation of manufacturing processes; ensure manufacturability and troubleshooting.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership for startup and rampup.
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Work nonstandard hours as required, transitioning to a 12-hour shift for 24/7 operations.

Skills

People management

cGMP

Manufacturing operations

Technology transfer

Regulatory compliance

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Amgen is seeking a Front Line Manufacturing Manager - Upstream Bulk Drug Substance in North Carolina to lead an expanding facility startup and ramp to 24/7 operations. You will oversee a cell culture manufacturing team, drive readiness, and coordinate across Quality, Engineering, and NPI to ensure compliant, efficient production.

The role requires a strong background in cGMP manufacturing, technology transfer, and people leadership, with Monday–Friday start and eventual 12-hour shifts.