Senior Associate Manufacturing - Continuous Improvement Lead

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Associate Manufacturing - Continuous Improvement Lead What you will do Let’s do this. Let’s change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. During start up, the Manufacturing Senior Associate Continuous Improvement (CI) Leads will have ownership and oversight of operational readiness activities in manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing. CI leads will support Standard Operating Procedure (SOP) creation, review, and approval; specification and purchasing of required equipment and supplies, design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff. When the plant transitions to operations in 2025 this position will manage and lead the CI program for MFG. Provide technical support and subject matter expertise for manufacturing area. Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, QMS records, among others. Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems. Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility Facilitate process, area, and equipment quality risk assessments as needed to identify risks, failure modes, and mitigating actions. When the plant is in production, manage the CI program; this includes conducting time studies to identify process inefficiencies, leading improvement projects in designated MFG area (i.e. upstream, downstream, solution prep), implementing proper change management, and tracking sustainment of implemented changes. Lead cross-functional CAPAs and EVs as required. Serve as a CI and Human and Organizational Performance champion. Provide training to others on CI and lean principles. Lead learning team meetings and kaizen events. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess strong project management and innovative thinking as well as these qualifications.

Requirements

High school diploma / GED and 4 years of Manufacturing or Operations experience
Associate’s degree and 2 years of Manufacturing or Operations experience
Bachelor’s degree and 6 months of Manufacturing or Operations experience
Strong project management and innovative thinking

Nice To Haves

Masters degree
Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff
Ability to lead small and large cross-functional meetings efficiently.
Knowledge of process improvement or lean fundamentals.
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality

Responsibilities

Support the start-up of the Amgen North Carolina (ANC) manufacturing facility.
Ownership and oversight of operational readiness activities in manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing.
Support Standard Operating Procedure (SOP) creation, review, and approval
Specification and purchasing of required equipment and supplies
Design of job aids and work instructions
Advancement of digital tools to support manufacturing operations
Training of staff
Manage and lead the CI program for MFG.
Provide technical support and subject matter expertise for manufacturing area.
Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, QMS records, among others.
Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility
Facilitate process, area, and equipment quality risk assessments as needed to identify risks, failure modes, and mitigating actions.
Manage the CI program; this includes conducting time studies to identify process inefficiencies, leading improvement projects in designated MFG area (i.e. upstream, downstream, solution prep), implementing proper change management, and tracking sustainment of implemented changes.
Lead cross-functional CAPAs and EVs as required.
Serve as a CI and Human and Organizational Performance champion.
Provide training to others on CI and lean principles.
Lead learning team meetings and kaizen events.