Manager Manufacturing (12hr PM)

Amgen • New Albany, OH

4d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. 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, 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. Manager, Manufacturing- 12 Hour PM (6:00pm - 6:30am) 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 an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed.

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.
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• 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 an overnight 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
• Regulatory requirements
• Scheduling
• Presentation Skills

Responsibilities

• 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 revalidation 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.

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, and flexible spending accounts
• A 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