Biotech Upstream Drug Substance Engineer — Scale-Up Expert

Amgen SA; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision

Stock incentives

Flexible work model

Paid time off

Job summary

Amgen Thousand Oaks is seeking an Engineer to join the Drug Substance Technology Engineering team, supporting transfer, validation, and manufacturing of biologics. The role focuses on transferring cell culture drug substance processes from lab to production sites and enabling scale-up across clinical and commercial spaces.

You’ll collaborate with Manufacturing, Quality, and Regulatory, contribute to deviations and CAPAs, and help optimize process performance while maintaining cGMP compliance.

Qualifications

• Master’s or higher in Chemical/Biochemical Engineering or related field.
• 3+ years in process engineering for biochemical/biopharma and cGMP biologics.
• Experience with cell culture and purification for biologics.
• Experience in commercial cGMP manufacturing.
• Understanding of scale-up from bench to commercial scale.
• Knowledge of aseptic processing and purification equipment.
• PD experience supporting cGMP at large scale.
• Strong analytical and problem-solving abilities.
• Ability to follow detailed protocols.
• Excellent written and verbal communication.

Responsibilities

• Transfer cell culture drug substance processes to manufacturing and sites.
• Provide process validation support for late-stage commercial processes.
• Offer on-the-floor technical support for scale-up and transfer.
• Provide routine process monitoring and troubleshooting.
• Perform data trending and statistical process analysis.
• Contribute to deviations (NCs), CAPAs and change controls.
• Identify opportunities for process-related operational excellence.
• Collaborate with Manufacturing, Quality, and Regulatory.

Skills

Process Development

Biochemical Engineering

Cell Culture

Scale-Up

cGMP

Troubleshooting

Technical Writing

Communication

Project Management

Education

Master’s degree in Chemical/Biochemical Engineering

Bachelor’s degree with 2 years of Process Development

Associate’s degree with 6 years of Process Development

High school diploma / GED with 8 years of Process Development

Tools

Chromatography

Ultrafiltration

Virus inactivation

Virus filtration

Scale-up equipment

Job description

Amgen Thousand Oaks is seeking an Engineer to join the Drug Substance Technology Engineering team, supporting transfer, validation, and manufacturing of biologics. The role focuses on transferring cell culture drug substance processes from lab to production sites and enabling scale-up across clinical and commercial spaces.

You’ll collaborate with Manufacturing, Quality, and Regulatory, contribute to deviations and CAPAs, and help optimize process performance while maintaining cGMP compliance.