Sr Manufacturing Manager - Continuous Improvement
Company: Amgen
Location: New Albany
Posted on: July 11, 2025
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Job Description:
Join 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. Sr Manufacturing Manager - Continuous
Improvement What you will do Lets do this. Lets change the world.
At Amgen, we are committed to being science-based and follow a
continuous learning approach to advancing science, driving
discovery and igniting innovation that works to help reduce
disease. It is in this context that we endorse an inclusive and
diverse workforce that helps fuel scientific innovation and problem
solving, leading to better scientific solutions that benefit both
patients and society. In this vital role you will be responsible
for leading and managing continuous improvement projects at the AOH
Assemble and Packaging Plant. Includes revision of documentation
(SOP, PTC, FORM, Manufacturing Procedure), QMS records (Deviation,
CAPA, Change Control, CAPA EV), Electronic Batch Records and Risk
Assessments. Reporting to the Executive Director Plant Manager,
this role will support the other functional areas Assembly and
Packaging (Vials, Syringes, Devices), Engineering, Process
Development, Quality, Validations, IS, Regulatory and other
functions as required. This role is crucial for AOH success, it is
a key contributor in AOH daily operation and is considered part of
the Leadership Team. Technical Manage the manufacturing Continuous
Improvement team that provides technical, project and
troubleshooting support to the manufacturing areas. Lead the
relevant continuous improvement team to achieve plant goals and
objectives Ensure consistent global operational practices are
implemented through alignment with standards and continued
evaluation of practices by engaging in relevant global networks and
teams Explain Assembly and Packaging process to other plant support
teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.) Oversee
the development, revision, review, and approval of documents (SOPs,
FORMS, Deviations, CAPAs, CC, etc) that are owned by the continuous
improvement team Support the plant in the project approval,
prioritization and implementation process Develop functional area
metrics to support the benchmarking of site, global, and industry.
Develop improvement strategies based off the benchmarking data.
Provide technical direction to the team Provide on-the-floor &
handson support in complex troubleshooting exercises Leads strategy
on OEE improvements Leads Yellow and Green Belt Manufacturing
initiatives Planning Lead in the development of the Continuous
Improvement teams long and short-term strategies, goals and
objectives that ensure the department and plant achieves the
company goals Ensure the coordination and goal alignment of
functional area and plant production operations Participate in
Plant Level Work Center Team (WCT) Meeting and Lead daily WCT
Develop plans and ensure adequate staffing and knowledge to ensure
Target Dates for the teams work (NPI, CAPA, Change Control, SOP and
EBR revision, risk assessments, etc.) are met Support Functions
Collaborate with and serve as department liaison to support other
organizations (Manufacturing, QA, F&E, PD, IS, etc.) Resolve
issues between manufacturing, quality and maintenance organizations
Compliance Ensure Assembly and Packaging practices (processes &
methods) and policies align with external regulatory requirements
and internal corporate and site guidelines and procedures Connect
with Regulatory Compliance and Quality Assurance to ensure the
functional area stays in compliance Develop, approve, establish and
ensure practices and policies are consistent Assure the appropriate
level of training is available and assigned for staff at all levels
of the relevant functional area Staff Coach, mentor and ensure the
development of supervisors and staff Partner with HR to recruit,
retain and empower staff Ensure an ongoing organizational structure
capable of adapting to changing business needs Ensure safety goals
are communicated and supported in alignment with ongoing plant
safety programs Ensure functional area staff exemplifies the Amgen
Values & Behaviors Ensure an executable Succession Plan is in place
for the relevant functional area What we expect of you We are all
different, yet we all use our unique contributions to serve
patients. The Sr Manager Manufacturing Support professional we seek
is a leader with these qualifications Doctorate degree and 2 years
of manufacturing support experience or Masters degree and 6 years
of manufacturing support experience or Bachelors degree and 8 years
of manufacturing support experience or Associates degree and 10
years of manufacturing support experience or High school diploma /
GED and 12 years of manufacturing support experience 2 years of
experience managing people and/or leadership experience leading
teams, projects, and programs or directing the allocation of
resources Preferred Qualifications: Educational background in Life
Sciences or Engineering Availability to support the manufacturing
operation on Non Standard Shifts, Nights or Weekends (On call
and/or on site) as needed Experience with Final Drug Product
manufacturing technologies / equipment, specifically Assembly and
Packaging manual and automated equipment Regulatory knowledge and
interactions Knowledge of conflict resolution and negotiating
skills Ability to partner with other departments / functions /
areas Analytical problem solving Considerable organizational skills
Technical writing and presentation skills. Basic project management
skills. Knowledge of control charting and statistics Experience in
coaching, mentoring and counseling Ability to deal with and manage
fast and constant change Ability to set goals Ability / experience
in working in fast paced manufacturing environment where issues
must be assessed, understood and resolved immediately Customer
satisfaction mentality Ample knowledge of cGMP Regulations around
Sterile Product Manufacturing, Combination Products and other
relevant area regulatory requirements Ability to maintain an
environment and culture of operational excellence and continuous
improvement Proven experience implementing a continuous improvement
program based on performance monitoring through KPIs Desire to
create an environment with Diversity, Inclusion and Belonging 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. The expected annual salary range for this role in the U.S.
(excluding Puerto Rico) is posted. Actual salary will vary based on
several factors including but not limited to, relevant skills,
experience, and qualifications. In addition to the base salary,
Amgen offers a Total Rewards Plan, based on eligibility, comprising
of health and welfare plans for staff and eligible dependents,
financial plans with opportunities to save towards retirement or
other goals, work/life balance, and career development
opportunities that may include: A comprehensive employee benefits
package, including a Retirement and Savings Plan with generous
company contributions, group medical, dental and vision coverage,
life and disability insurance, and flexible spending accounts A
discretionary annual bonus program, or for field sales
representatives, a sales-based incentive plan Stock-based long-term
incentives Award-winning time-off plans Flexible work models,
including remote and hybrid work arrangements, where possible Apply
now and make a lasting impact with the Amgen team.
careers.amgen.com In any materials you submit, you may redact or
remove age-identifying information such as age, date of birth, or
dates of school attendance or graduation. You will not be penalized
for redacting or removing this information. Application deadline
Amgen anticipates accepting applications until 6/30/2025; however,
we may continue accepting applications beyond this date if we do
not receive a sufficient number of candidates. 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, Middletown , Sr Manufacturing Manager - Continuous Improvement, Manufacturing , New Albany, Ohio
