Manager Manufacturing (12hr PM Shift)

About the role

Amgen is hiring a Manufacturing Manager for a 12-hour PM shift (6:00pm to 6:30am) in an Inspection and Packaging facility. The manager leads all aspects of a small production area or a section of a larger one and keeps production running in full cGMP compliance. The position supports a rotating 12-hour schedule that cycles every two weeks.

Key responsibilities

• Supervise, hire and develop staff and ensure production schedules are met
• Ensure cGMP and CFR compliance of manufacturing areas and follow corporate change control procedures, notifying Regulatory and QA before changes
• Evaluate and approve reports and protocols, revise procedures and coordinate updates to SOPs
• Ensure maintenance and revalidation of systems and coordinate the setup of critical new manufacturing processes
• Collaborate with QA/QC, PPIC, Clinical Mfg, PD and Regulatory teams and resolve operational problems
• Select, train and evaluate staff, maintain training programs and schedule production and maintenance activities
• Plan and maintain the budget, help set department goals, audit for plant safety and interact with the FDA

Required profile

• One of: doctorate or master's degree with 3 years of experience, bachelor's degree with 5 years, associate's degree with 10 years, or high school diploma/GED with 12 years, in the pharmaceutical, medical device or biotechnology industry
• Experience directly managing people and/or leading teams, projects or programs
• Preferred: science, engineering or business administration background, availability for overnight shifts, strong managerial skills

Required skills

• Non-conformance and CAPA handling
• Leadership, team building, conflict resolution and analytical problem solving
• Technical writing, presentation and scheduling skills

What we offer

• Annual salary range of $106,148 to $143,612 USD, depending on skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, retirement savings plan and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives and time-off plans
• Flexible work models, including remote and hybrid options where possible