Amgen Inc. is hiring a Process Development Engineer I - Biologics Drug Substance to join our mission of serving patients with serious illnesses. In this role, you will be responsible for technology transfer and commercial support of biologics drug substance processes across our manufacturing network, applying engineering principles within a cGMP environment.
What You'll Do
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision, evaluate, select, and apply standard engineering techniques and procedures.
- Perform assignments that have clear, specific objectives and require investigation of a limited number of variables.
- Initiate and complete routine technical tasks.
- Function as a technical expert for equipment or systems regarding troubleshooting operations.
- Routinely monitor manufacturing processes for performance indicators and operations.
- Apply engineering principles and statistical analysis, including design of experiments, to solve processing issues and evaluate opportunities for improvements.
- Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for process or system modifications.
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects, and engineering firms on the development of standard design documents.
- Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
- Support non-standard shift organization and extended hours, as per business needs.
- Travel domestically and internationally up to 15%.
What We're Looking For
- High school diploma / GED and 8 years of Engineering or Operations experience
- Associate’s degree and 6 years of Engineering or Operations experience
- Bachelor’s degree and 2 years of Engineering or Operations experience
- Master's degree
Nice to Have
- Education background in Chemical Engineering, Bioengineering, or Biotechnology
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in implementing and supporting biopharmaceutical manufacturing processes
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Experience working with commercial manufacture of biologics using single use technology
- Basic understanding of cGMP requirements
- Experience related to upstream and/or downstream biologics process development, technology transfer, scale-up, and ongoing manufacturing of biologics (cGMP)
- Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration for a variety of biological molecules
- Experience in the analysis of data generated from a variety of analytical techniques
- Regulatory knowledge and interactions
- Project management skills
- Strong oral and verbal communication and presentation skills
- Fluency in foreign languages
Technical Stack
- cGMP environment
- Single use technology
- Cell expansion
- Harvest
- Clarification
- Protein A
- IEX
- SEC
- TFF
- UFDF
- Sterile filtration
Team & Environment
You will work as a member of a team of engineers and scientists, reporting to project managers, in a collaborative, innovative, and science-based culture focused on oncology, inflammation, general medicine, and rare disease.
Benefits & Compensation
- Compensation range: $93,344.00 - $107,268.00
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Work Mode
This is a hybrid position based in the U.S. (excluding Puerto Rico).
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.
