Manager Manufacturing (12hr PM

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 illnesses drives 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Manager, Manufacturing- 12 Hour PM (6:00pm - 6:30am)

Lets do this. Lets 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.

• Evaluate and approve reports and protocols.

• Ensure cGMP and CFR compliance of manufacturing areas.

• Revise, update, and review procedures

• Coordinate the development and revision of SOPs.

• Evaluate current manufacturing 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

• 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.

• 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.

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

• Assist in developing and maintaining department goals

• This position will be supporting a rotating 12hr schedule which cycles every two weeks; 3 days one week and 4 days the next.

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

Doctorate degree

or

Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

or

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

or

Associates 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.

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

• Educational background in Science, Engineering or Business Administration

• Availability to work on an overnight shift

• Strong…