Senior Engineer - Drug Substance Technology & Engineering

Career Category

Operations

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide downstream purification manufacturing support supporting a diverse portfolio of both clinical and commercial biologics drug substance products. You will provide engineering oversight and play a key role in early phase technology transfer and the manufacturing execution, process optimization, and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

The role combines hands-on technical leadership with direct people management. You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and contract site(s) to ensure successful technology transfer, manufacturing, and regulatory support. You will also use your engineering experience in the oversight and operations of production facilities; including process execution, equipment utilization, and optimization. Additionally, you will directly manage and develop other downstream process engineers, and guide manufacturing execution, on-floor escalation support, process monitoring, complex investigations, and process improvement across downstream purification operations.

You will build productive partnerships with Manufacturing, Quality, Process Development, Validation, Regulatory, Facilities and Engineering, Supply Chain, and network teams in support of a highly dynamic manufacturing facility. Limited domestic and international travel may be necessary at times.

The ideal candidate should be well versed in tech transfer, process development, scale up, modeling, optimization, characterization, regulatory support and GMP commercial production.

Lead technical support for cGMP clinical and commercial downstream purification processes, including harvest and clarification, chromatography, viral filtration, UF/DF, and sterile filtration.

Initiate and execute technology transfer and manufacturing support activities, including process transfer documentation, process and facility-fit assessments, risk analyses, manufacturing readiness activities, and process documentation.

Represent DSTE on cross-functional teams to ensure deliverables supporting technology transfer, manufacturing execution, investigations, and process improvements are completed on schedule.

Provide on-floor manufacturing support and technical escalation support to enable safe, compliant, and reliable manufacturing execution.

Routinely monitor process and operational performance using relevant manufacturing, process, and product data. Lead problem resolution and provide troubleshooting guidance for process performance issues.

Apply engineering principles, statistical analysis, and design of experiments, as appropriate, to investigate processing issues, identify process risks, and evaluate process improvement opportunities.

Lead or support deviations, investigations, root-cause analyses, CAPAs, change controls, and risk assessments. Develop timely controls and effective actions that reduce recurrence.

Evaluate, select, and apply appropriate engineering techniques and procedures to resolve technical process, equipment, and manufacturing issues.

Partner with Process Development to ensure processes are robust, scalable, and designed to consistently deliver required product quality attributes and enable manufacturing success.

Collaborate with Manufacturing, Quality, Process Development, Validation, Regulatory, Supply Chain, Facilities and Engineering, and network drug substance teams to deliver technical solutions and achieve plant and project objectives.

Author, review, and maintain technical documentation, including protocols, reports, process assessments, standard operating procedures, batch record support documents, and engineering assessments.

Contribute to process validation, PPQ, continued process verification, process monitoring, regulatory filings, inspections, and other CMC activities, as needed.

Ensure manufacturing operations are aligned with the registered process, applicable cGMP requirements, site procedures, and established safety and quality standards.

Lead cross-functional problem-solving efforts while balancing quality, schedule, cost, and operational considerations.

Share technical expertise and mentor less experienced engineers in downstream process knowledge, troubleshooting, data analysis, and manufacturing support practices.

Leadership:

Ensures that safe practices are followed.

Provides mentoring and expertise to staff on the downstream team.

Develop high-performing engineers by coaching through complex technical decisions, investigations, and project delivery while encouraging independent problem solving and sound judgment.

Collaborates within the department and interdepartmentally.

Provides scientific and technical leadership.

Ensure department staff are adequately developed and trained.

Initiates and encourages scientific collaboration with groups outside the department.

Build and maintain effective collaborations with partner organizations.

Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities.

Inform and consults department head and senior staff appropriately

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

• Doctorate degree
• OR
• Master’s degree and 2 years of Engineering experience
• OR
• Bachelor’s degree and 4 years of Engineering experience
• OR
• Associate’s degree and 8 years of Engineering experience
• OR
• High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications:

Engineer with 5+ years of experience in downstream purification, and providing and driving engineering deliverables for pharmaceutical processes and product development.

2+ years of experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.

Demonstrates technical leadership of cross-functional teams, projects, or programs, including the ability to influence decisions and coordinate work across competing priorities.

Strong, in-depth expertise in downstream purification processes and commercial biologics manufacturing operations.

Experience supporting process development, scale-up, technology transfer, process validation, PPQ, continued process verification, and manufacturing execution.

Strong understanding of cGMP, regulatory, safety, and quality requirements, including experience supporting regulatory filings, inspections, and product lifecycle activities.

Ability to apply engineering principles, statistical analysis, analytical methods, and process data to troubleshoot processing issues, evaluate product and process performance, and identify improvement opportunities.

Experience with