Senior Associate Manufacturing - Continuous Improvement Lead
Company: Amgen
Location: Holly Springs
Posted on: March 16, 2026
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Job Description:
Job DescriptionJoin Amgens Mission of Serving Patients At Amgen,
if you feel like youre part of something bigger, its because you
are. Our shared missionto serve patients living with serious
illnessesdrives all that we do. Since 1980, weve helped pioneer the
world of biotech in our fight against the worlds 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, youll 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, youll 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 Lets do this. Lets
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. Basic
Qualifications: High school diploma / GED and 4 years of
Manufacturing or Operations experience OR Associates degree and 2
years of Manufacturing or Operations experience OR Bachelors degree
and 6 months of Manufacturing or Operations experience Masters
degree Preferred Qualifications: 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 What you can expect of us As
we work to develop treatments that take care of others, we also
work to care for your professional and personal growth and
well-being. From our competitive benefits to our collaborative
culture, well support your journey every step of the way. In
addition to the base salary, Amgen offers competitive and
comprehensive Total Rewards Plans that are aligned with local
industry standards. Apply now and make a lasting impact with the
Amgen team. careers.amgen.com As an organization dedicated to
improving the quality of life for people around the world, Amgen
fosters an inclusive environment of diverse, ethical, committed and
highly accomplished people who respect each other and live the
Amgen values to continue advancing science to serve patients.
Together, we compete in the fight against serious disease. 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. We will ensure that individuals with
disabilities are provided reasonable accommodation to participate
in the job application or interview process, to perform essential
job functions, and to receive other benefits and privileges of
employment. Please contact us to request accommodation.
Keywords: Amgen, Danville , Senior Associate Manufacturing - Continuous Improvement Lead, Manufacturing , Holly Springs, Virginia
