Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Amgen is seeking a Manager Manufacturing Services to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing operations including Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave, and material handling, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility. The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5pm. This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

Requirements

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
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

Bachelor’s degree in Life Sciences or Engineering
Experience with facility startup, commissioning, or operational readiness
Biologics / drug substance manufacturing experience (Services)
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

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 (C&Q), 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, troubleshooting, 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, transitioning to a 12-hour 2-2-3 day shift supporting 24/7 operations.