DOWNSTREAM – Amgen Careers Irvine

Position Title:  DOWNSTREAM

Company: Amgen

Location: Irvine, CA, USA

Job Description:

The Principal Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings. This role provides a great opportunity for significant career development in areas of leadership, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems.

Responsibilities:

• Supervise a team of Process Development Engineers focused on downstream protein purification processes
• Plan, prioritize and coordinate work of a staff of process engineers
• Apply a fundamental understanding of protein purification unit operations to support commercial manufacturing processes:
• Large Scale Column Chromatography
• Tangential flow filtration
• Normal Flow Filtration
• Virus Inactivation and Virus Filtration
• Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.
• Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials.
• Evaluate process capabilities to develop and implement process and yield improvement opportunities.

Requirements:

• Partner with the Process Development laboratories to design experimentation to support process scale up. Perform technical review of data, and author and review GMP documentation.
• Execute technology transfer projects to support Amgen Network initiatives.
• Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
• Collaborate with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress.
• Perform work that involves in-depth investigation of subject area.
• Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications.
• Design, execute, implement, and direct engineering or process projects which significantly contribute to attaining high priority goals.
• Interpretation of Processes Characterization.
• Establish Testing Strategies.
• Design / Development of Characterization Protocols.
• Technical Reports Development.
• Validations, and technical reports- support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.