Manager Manufacturing (12hr shift)

Amgen • New Albany, OH

21d

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. Manufacturing Manager 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 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.

Requirements

• 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.
• 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, prograns, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• Educational background in Science, Engineering or Business Administration
• Availability to work on a 12-hour PM shift
• Strong Managerial skills
• Non-Conformance and CAPA
• 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

Responsibilities

• 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
• 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
• Ensure that all Non-conformance are triage within the established goal.

Benefits

• comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees