Job Summary
- Company
- Amgen Rhode Island Immunex
- Location
- West Greenwich, RI 02817
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 50473531
Principal Engineer (Process Development) NB50473531 - Rhode Island
About the Job
Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.
Support of commercial manufacturing at Amgen’s or contracted manufacturing sites including process performance monitoring; implementation of process improvement strategies; development of process models; and scale-up and technology transfer of new processes across sites. Function as a technical expert for processes or systems regarding troubleshooting and operation in cell culture, bioreactors and harvest. Lead and participate in operational excellence activities including idea generation, feasibility determination and implementation at manufacturing scale. Lead and participate in development and evaluation of new technologies for implementation in routine manufacturing. Actively lead cross-functional efforts to resolve complex problems while meeting quality, schedule, and cost objectives. Perform individually or in teams; set appropriate priorities for tasks; handle multiple projects and assignments simultaneously; and provide appropriate direction and guidance to the junior staff. Review and improve manufacturing and operating procedures, provide input to corrective and preventive actions, perform root-cause analysis of process failures while ensuring cross-functional collaboration with relevant functional representatives, including Manufacturing, Engineering, Facilities, EH&S, Quality Assurance, Regulatory, and Validation. Translate process, operational, and regulatory needs into user requirement specifications for new and existing products; develop and execute project plans; and ensure that the project deliverables are consistent with business needs. Infrequent travel to domestic and international contract manufacturing sites may be required.
Basic Qualifications:
BS in Biochemical, Chemical or Biomedical Engineering, or in a relevant technological field
8+ years of experience in a cGMP biopharmaceutical or pharmaceutical process development or manufacturing environment
Knowledge and hands-on experience of large-scale cell culture, bioreactor design, control and operation, and harvest operation by centrifugation.
Scale-up and technology transfer experience of commercial cell culture processes.
Experience with biopharmaceutical equipment including troubleshooting, reliability and uptime enhancements, implementation, validation, and change control methodology within a regulated manufacturing environment.
Preferred Qualifications:
MS or PhD. in Biochemical, Chemical or Biomedical Engineering, or in a relevant technological field
Knowledge and understanding of cell line development, host systems, cell biology, media development and protein structure and function.
Knowledge and understanding of statistical methods, first-principles modeling, use of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization is desirable.
Excellent written and verbal communication skills
Strong customer orientation and cross-functional collaboration skills
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion is essential.
Coach/mentor/direct junior engineers in the department
Demonstrated skills in team-building, negotiation, facilitation and conflict resolution
Experience of cross-cultural and cross-industry technical collaboration
Support of commercial manufacturing at Amgen’s or contracted manufacturing sites including process performance monitoring; implementation of process improvement strategies; development of process models; and scale-up and technology transfer of new processes across sites. Function as a technical expert for processes or systems regarding troubleshooting and operation in cell culture, bioreactors and harvest. Lead and participate in operational excellence activities including idea generation, feasibility determination and implementation at manufacturing scale. Lead and participate in development and evaluation of new technologies for implementation in routine manufacturing. Actively lead cross-functional efforts to resolve complex problems while meeting quality, schedule, and cost objectives. Perform individually or in teams; set appropriate priorities for tasks; handle multiple projects and assignments simultaneously; and provide appropriate direction and guidance to the junior staff. Review and improve manufacturing and operating procedures, provide input to corrective and preventive actions, perform root-cause analysis of process failures while ensuring cross-functional collaboration with relevant functional representatives, including Manufacturing, Engineering, Facilities, EH&S, Quality Assurance, Regulatory, and Validation. Translate process, operational, and regulatory needs into user requirement specifications for new and existing products; develop and execute project plans; and ensure that the project deliverables are consistent with business needs. Infrequent travel to domestic and international contract manufacturing sites may be required.
Basic Qualifications:
BS in Biochemical, Chemical or Biomedical Engineering, or in a relevant technological field
8+ years of experience in a cGMP biopharmaceutical or pharmaceutical process development or manufacturing environment
Knowledge and hands-on experience of large-scale cell culture, bioreactor design, control and operation, and harvest operation by centrifugation.
Scale-up and technology transfer experience of commercial cell culture processes.
Experience with biopharmaceutical equipment including troubleshooting, reliability and uptime enhancements, implementation, validation, and change control methodology within a regulated manufacturing environment.
Preferred Qualifications:
MS or PhD. in Biochemical, Chemical or Biomedical Engineering, or in a relevant technological field
Knowledge and understanding of cell line development, host systems, cell biology, media development and protein structure and function.
Knowledge and understanding of statistical methods, first-principles modeling, use of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization is desirable.
Excellent written and verbal communication skills
Strong customer orientation and cross-functional collaboration skills
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion is essential.
Coach/mentor/direct junior engineers in the department
Demonstrated skills in team-building, negotiation, facilitation and conflict resolution
Experience of cross-cultural and cross-industry technical collaboration
Additional Information:
- Travel Percentage: 5%
Company Tools
Contact Information
Amgen Rhode Island Immunex
