Senior Associate Pilot Plant Operations

Job Summary

We are seeking a Senior Associate Pilot Plant to join the Operations Team that supports ATO B30 PP, AMA SUL and ARI PEL. The successful candidate will be responsible for supporting the Pilot Plant's GMP Project execution and compliance, Business Performance Management, Raw Material Planning, Continuous Improvement Project Management, and overall logistical support for the Pilot Plant Network production areas. You will support plant resources and staff to ensure area and plant execution goals are met, working with our Process Development customers to deliver upon their highest priority needs.

Areas Of Responsibility:

• Support GMP operations through event management, document review, and investigations
• Maintain appropriate GMP raw material stock to ensure product supply
• Improve raw material kitting process, ULS delivery, and consumables
• Pilot Plant Network (PPN) Training Assignment Portfolio review, maintenance, and GMP compliance
• Manage Project Prioritization Process (P3) and support alignment across PPN
• Advance PPN Work Center Team Process to realize roll up/down of performance from floor to PP Network "plant" level
• Advance business software for scheduling, run planning and business reporting
• Share Business Practices around NPI (NPI Guidelines, Sample Plans, BOMs, and Checklists)
• Identify and Prioritize Sharing and Alignment Opportunities for the PPN
• Perform robust New Product Introduction (NPI) with long-lead raw material procurement meeting target timelines
• Update Pilot Plant NPI Business Practice document(s)

The Pilot Plant is a flexible, dynamic development space where Amgen enables GMP alongside development. Employing strong, self-directed leadership skills, you and your team will be responsible for translating bench scale bioprocessing science into manufacturing scale production methods to support preclinical, clinical and commercial activities.

Amgen Pilot Plants perform frequent piloting of novel process operations, driving technology development and innovation, as well as executing bioprocessing operations. We produce sound, relevant data for the processes Amgen developments at meaningful scales that enable the rapid, successful transfer of our output to more dedicated manufacturing spaces. You will work with the Production Teams, our Clients and the many Support Teams to ensure successful, agile execution.

The Pilot Plants focus primarily on large molecule cell culture and purification operations, from vial thaw to completion of Drug Substance, and will also support innovation across Amgen's entire spectrum. The environment is challenging, fast-paced and ever-changing but very rewarding for those that like hands on science and want to make process improvements in a development space.

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Manufacturing or Process Development experience

OR

Associate's degree and 6 years of Manufacturing or Process Development experience

OR

High school diploma / GED and 8 years of Manufacturing or Process Development experience

Preferred Qualifications:

• Master's degree in engineering, life sciences, chemistry or other applicable sciences

• Master's in Business Administration (MBA) with 2 or more years applying concepts in technical function

• Project Management certification or 2 or more years managing large projects with diverse teams

• 4 or more years of experience in executing or supporting manufacturing, process development and/or engineering

• Experience managing process improvement, utilizing Operational Excellence tools and techniques (Catalyst, Lean Manufacturing, Kaizen, 5S)

• Excellent communication and negotiation skills, including Management level communications

• Experience in a matrixed/global environment at a large company and working in a team driven environment

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.