Senior Engineer, Process Development; Downstream

Senior Engineer, Process Development (Downstream)

Join to apply for the Senior Engineer, Process Development (Downstream) role at Bio Space.

At Amgen, our mission is to serve patients living with serious illnesses. Since 1980, we have pioneered biopharmaceutical innovations across oncology, inflammation, general medicine, and rare disease.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility will combine disposable technologies with traditional stainless‑steel equipment for maximum flexibility and sustainability.

• 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.

• 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.

• Master’s degree in Engineering or Science discipline.
• 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (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 with diverse internal and external stakeholders.
• Able to apply engineering principles and statistical analysis in resolving complex issues.
• Knowledge of regulatory filings and inspections.
• Knowledge of broad aspects of biologics processing (cell culture, analytical methods, or product quality attributes).
• Familiarity with operational aspects of commercial biopharma manufacturing (process automation, equipment, single‑use).

Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards. Base salary plus benefits.

Seniority level:
Mid‑Senior level

Employment type:

Full‑time
Job function:
Engineering and Information Technology
Industry: Internet News

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.