Career Category

Job Description

“Does the thought of building an entirely new site from the ground up excite you? Do you love building and developing impactful teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.”

Manager Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a Third Shift. Several positions available.

Specific responsibilities include but are not limited to:

Compliance:

• Evaluate and approve reports and protocols.
• Ensure cGMP and CFR compliance of operating areas.
• Revise, update, and review procedures
• Manage the development and revision of SOPs.
• Evaluate current operating procedures and recommend changes to management to optimize production.
• Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the changes.
• Interact with the FDA.
• Ensure Amgen policies are followed

Process/Equipment/Facilities:

• Ensure maintenance and re validation of systems.
• Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.
• Develop, implement and assess solutions for problems.
• Responsible for resolving problems during operation.
• Coordinates set up of critical new manufacturing processes.

Staff Supervision

• Responsible for selection, training, evaluation, staff relations and development of staff.
• Ensure training programs are maintained
• Ensure scheduling of production and maintenance activities.
• Interacts with management in optimizing organizational structure and responsibilities
• Ensure plant safety through auditing and evaluations.

Administrative:

• Interacts with management in planning, developing and maintaining budget.
• Assist in developing and maintaining department goals

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

Basic qualifications

Doctorate degree

or

Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

or

Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.

or

Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry.

or

High School Diploma/GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry.

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or the allocation of resources.

Preferred qualifications

• Educational background in Science, Engineering or Business Administration
• Availability to work on a third (3rd shift)
• Strong Managerial skills
• Non-Conformance and CAPA
• Ensure that all Non-conformance are triage within the established goal.
• Leadership and team building
• Verbal communication
• Written Communication including technical writing skills
• Conflict Resolution
• Analytical Problem Solving
• Project Management
• Coaching, Mentoring and Counseling
• Ability to be flexible and manage change
• Regulatory requirements
• Scheduling
• Presentation Skills

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

#AmgenOhio

Apply now

for a career that defies imagination

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

careers.amgen.com