Senior Engineer - Drug Substance Technology & Engineering
Amgen
Summary
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.
Job description
- 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.
- 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.
- Collaborate with Manufacturing, Quality, Process Development, Validation, Regulatory, Supply Chain, Facilities and Engineering, and network drug substance teams.
- 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.
- 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.
- 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.
Requirements
- 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
- 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 process monitoring, Quality by Design, Process Analytical Technology, process modeling, or data visualization tools used to support biological processing
- Ability to critically evaluate biological processes and manufacturing systems to identify process improvements, scale-up considerations, technology transfer risks, and facility-fit requirements
- Strong written, verbal, and presentation skills, with the ability to communicate complex technical information effectively to diverse stakeholders
- Demonstrated teamwork, mature process-fit assessment skills, and a strong understanding of plant safety practices
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.