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Manager Manufacturing Support

Employer
Amgen
Location
New Albany, Ohio
Start date
May 24, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager, Manufacturing Support

Live

What you will do

Lets do this. Lets change the world. This role will support the manufacturing team to assure product is produced Right First Time and to the highest standard of quality to align with regulatory requirements. This position requires a strong, collaborative nature while also working as a proactive, autonomous subject matter expert.

In this role, you will manage a team of manufacturing senior associates (technical writers) and provide technical expertise and oversight of developing, reviewing, and maintain the lifecycle of manufacturing documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

Not only will the Manager, Manufacturing play a key role in technical writing, but will also provide expertise in the Quality Management System (QMS) at Amgen. This will include QMS process implementation and execution on deviations, CAPAs, and change controls.

Responsibilities may include, but are not limited to:
  • Lead the team responsible for lifecycle management of manufacturing documentation in DMS.
  • Oversee the creation and/or revision of controlled documents, including SOPs, WI, technical reports, and training materials.
  • Ensure documentation-related activities are completed accurately, timely, and remain current.
  • Lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management.
  • Optimize staff responsibilities and organizational structure to ensure effective project planning and execution.
  • Collaborate with cross-functional teams to ensure GMP standards are in-line with current operating systems.
  • Support Amgen through continuous improvement and process improvement initiatives.
  • Provide training and support to colleagues.
  • Support audits and inspections, which may include direct interaction with regulatory agencies.
  • Drive lean transformation and operational excellence initiatives.
  • Build and maintain strong relationships within the Amgen Network to share standard processes and align on streamlined initiatives.

Win

What we expect of you

Masters Degree in Science, Engineering, or an equivalent technical field with an additional 3 years of Manufacturing, Packaging, or Quality career experience

Basic Qualifications:Doctorate degree

OR

Masters Degree in Science, Engineering, or an equivalent technical field with an additional 3 years of Manufacturing, Packaging, or Quality career experience

Or

Bachelor's Degree in Science, Engineering, or an equivalent technical field with an additional 5 years of Manufacturing, Packaging, or Quality career experience

Or

Associates Degree in Science, Engineering, or an equivalent technical field with an additional 10 years of Manufacturing, Packaging, or Quality career experience

Or

High school diploma / GED and 12 years of Manufacturing, Packaging, or Quality career experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:
  • Experience working in pharmaceutical and/or biotechnology industry.
  • Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
  • Experience in leading or supporting deviations, investigations, CAPAs and change controls.
  • Experience with device assembly and packaging of final product.
  • Ability to translate highly technical information into easily understandable information for manufacturing operators.
  • Leader in problem solving and making risk-based decisions to maintain quality and compliance.
  • Experience with Regulatory agencies.
  • A fact-based problem solver with strong troubleshooting and problem-solving skills.
  • Pro-active, result driven, and ability to prioritize work to meet deadlines.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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