Manager Manufacturing; shift

Join to apply for the Manager Manufacturing (12hr shift) role at Amgen

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 lie within them, you’ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

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.

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.
• Coordinate 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.
• Interact with management in optimizing organizational structure and responsibilities.
• Ensure plant safety through auditing and evaluations.

Administrative

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

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

• Doctorate degree
• Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
• Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry
• Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry
• High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

• 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
• Regulato…