Does the thought of building an entirely new site from the ground up excite you? Do you love building and developing impactful teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this new opportunity.
Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgens plan to be a carbon-neutral company by 2027.
What you will do
Lets do this. Lets 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 in a Third Shift. Several positions available.Specific responsibilities include but are not limited to:
- 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
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
Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industryor
Bachelors degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.or
Associates 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 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
- Presentation Skills
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.