Amgen · 1 month ago
Senior Engineer, Process Development (Downstream)
US - North Carolina - Holly Springs
Full-time
Onsite
Mid, Senior Level
$119K/yr - $148K/yr
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Engineer in Process Development will focus on technology transfer and process optimization at Amgen's FleX Batch facility, ensuring high-quality medicine delivery through collaboration and technical leadership.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Support technology transfer, process validation, and plant start-up
Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
Provide on-the-floor process support as required
Ensure safety and compliance of process development activities
Collaborate with other site-functions and network drug substance teams in delivering plant goals
Support regulatory filing, inspection, and other CMC activities
Qualification
Required
High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR
Bachelor's degree and 4 years of biologics process development or commercial-scale technical support experience OR
Master's degree and 2 years of biologics process development or commercial-scale technical support experience OR
Doctorate degree
Preferred
Master's degree in Engineering or Science discipline
5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
In-depth expertise in biologics process purification processes
Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Able to apply engineering principles and statistical analysis in resolving complex issues
Knowledge in regulatory filings and inspections
Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)
Benefits
Competitive and comprehensive Total Rewards Plans
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
2026-01-13
Genetic Engineering News
2026-01-12
Company data provided by crunchbase