Manager Manufacturing (12hr shift) - New Albany, OH bei Amgen
Amgen · New Albany, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in New Albany
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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
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
Job_Category
Management
Minimum Education Required
High School/GED
City*
New Albany
Additional Qualifications/Responsibilities
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.
Basic Qualifications:
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
Preferred Qualifications:
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
Regulatory requirements
Scheduling
Presentation Skills
Salary Range
114,259.00 USD - 133,764.00 USD
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.
Basic Qualifications:
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
Preferred Qualifications:
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
Regulatory requirements
Scheduling
Presentation Skills
Salary Range
114,259.00 USD - 133,764.00 USD
State*
Ohio
Salary Range
>$100,000
