Job Description:
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
MANAGER MANUFACTURING
LIVE
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.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Compliance:
- 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
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 a budget.
- Assist in developing and maintaining department goals
SHIFT:
- This position will be supporting shift work. Shifts are to be determined
WIN
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.
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.
And
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or the allocation of resources.
PREFERRED QUALIFICATIONS:
- Educational background in Science, Engineering or Business Administration
- Availability to work on a third (3rd shift)
- Strong Managerial skills
- Non-Conformance and CAPA
- Ensure that all Non-conformance are triaged 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
THRIVE
WHAT YOU CAN EXPECT OF US
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $101,569.00 – $123,545.00.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
