Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Amgen•Holly Springs, NC

4d•Onsite

About The Position

Amgen is seeking a Senior Associate Manufacturing - New Product Introduction Systems to join their Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This role is crucial for supporting New Product Introduction (NPI) programs by coordinating cross-functional activities to ensure compliant and timely implementation. The position will focus on Quality Risk Assessments, maintaining Continuous Improvement records, creating and managing process Bills of Materials (BOMs), and owning assigned Change Control records. The role requires broad interaction with Manufacturing, Quality, Process Development, Supply Chain, Manufacturing Execution Systems (MES), and Single-Use Systems (SUS) to align requirements, track execution, and maintain documentation.

Requirements

Master's degree OR Bachelor's degree and 4 years of Manufacturing or Operations experience OR Associate's degree and 8 years of Manufacturing or Operations experience OR High school diploma / GED and 10 years of Manufacturing or Operations experience
Experience in GMP manufacturing or manufacturing support
Strong cross-functional coordination skills
Meeting facilitation skills
Technical writing skills
Quality-system skills

Nice To Haves

Degree in Science, Engineering, Supply Chain, Operations, or a related field.
Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain.
Experience facilitating cross-functional Quality Risk Assessments, FMEAs, or similar structured risk-management activities.
Experience using Quality Management Systems such as Veeva QMS or TrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records.
Experience creating or maintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions.
Working knowledge of drug substance manufacturing and the relationship between process requirements, materials, manufacturing documents, and electronic batch records or MES.
Strong cross-functional project coordination skills
Compliant documentation skills.
Ability to manage multiple priorities, maintain trackers, follow up on actions, and deliver work to established timelines.
Excellent written and verbal communication skills with the ability to build effective relationships in a matrix environment.
Ability to work independently within a defined scope, recognize when guidance is needed, and escalate risks promptly.

Responsibilities

Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval.
Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting records in accordance with applicable procedures and quality requirements.
Create and maintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements.
Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to support accurate material readiness and alignment across systems and documents.
Own assigned NPI Change Control records under management guidance; prepare and maintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases.
Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and escalate risks or delays.
Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure.
Maintain trackers and provide clear, routine status readiness updates to NPI management and cross-functional partners.
Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to support timely execution.