Manufacturing Manager (Device Assembly and Packaging) - 12hr PM Shift

Amgen • New Albany, OH

217d • $114,259 - $133,764 • Hybrid

About The Position

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 lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Doctorate degree or 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.

Nice To Haves

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

Responsibilities

• Manage and lead all aspects of a small manufacturing production area or a section of a larger production area in an Inspection and Packaging facility.
• Maintain production in full cGMP compliance.
• Supervise, hire, and develop staff and ensure 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.
• Ensure all corporate change control procedures are followed.
• Interact with the FDA.
• Ensure Amgen policies are followed.
• Ensure maintenance and re-validation of systems.
• Collaborate with cross-functional teams 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.
• 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.
• Interact with management in planning, developing and maintaining budget.
• Assist in developing and maintaining department goals.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Master's degree