Manager, Manufacturing - 12hr PM

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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

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 a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a shift.

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

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:

• Educational background in Science, Engineering or Business Administration
• Availability to work on a 12-hour PM 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

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 s