Amgen · 2 months ago
Senior Engineer- Process Development/NPI
US - Ohio - New Albany
Full-time
Hybrid
Mid, Senior Level
$119K/yr - $148K/yr
4+ years expAmgen is a leading biotechnology company focused on serving patients living with serious illnesses. The Senior Engineer in Process Development/NPI will manage new process introductions for drug products, ensuring effective transfer into manufacturing while leading multi-functional teams and coordinating NPI activities.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio
Lead the NPI’s for necessary process, facility, equipment, materials, and training modifications
Development of project execution plans
Ensure process requirements are effectively transferred into manufacturing
Coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities
Work with various NPI support groups to develop, maintain, and implement the NPI project plan
Function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management
Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks
Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI
Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications)
Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies
Support a safe working environment by staying in sync with all pertinent environmental health/safety practice, rules and regulations
Lead and manage change control processes for New Product Introductions (NPI), ensuring timely approvals, regulatory compliance, and seamless implementation across cross-functional teams
Monitor and track NPI-related changes to ensure proper risk assessment, mitigation strategies, and alignment with project timelines
Qualification
Required
Doctorate degree
Master's degree and 2 years of Process Development, Engineering, or NPI experience
Bachelor's degree and 4 years of Process Development, Engineering, or NPI experience
Associate's degree and 8 years of Process Development, Engineering, or NPI experience
High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
Genetic Engineering News
2026-01-12
2026-01-11
Company data provided by crunchbase