HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Senior Manager ManufacturingLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for managing the life cycle and day to day production support requirements associated with the products and process equipment for our Amgen Rhode Island AR5 and AR30 manufacturing facilities. Specific responsibilities include:
- Serve on the manufacturing leadership team, including daily management for both plants
- Provide tactical and strategic management and leadership for operational support and project execution and ensure delivery to short and long-term Amgen Rhode Island site operational goals
- Build, develop and retain a diverse and high performing team, including coaching and developing staff towards their fullest potential to support an engaged motivated workforce.
- Effectively collaborate with key customers and support groups (Manufacturing, Quality, Process Development, Engineering, and network partners) and drive new business processes to ensure continuous and sustained improvement.
- Responsible for product lifecycle management and associated electronic batch records, including all new product introductions and product re-introductions into the plant
- Responsible for the validation master plan, including strategy, cleaning validation, etc
- Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage call coverage for 24/7 operation
- Manage change controls, corrective actions and preventative actions associated with products and process equipment
- Own and lead investigations associated with process deviations and non-conformances
- Deliver results in accordance with cGMP and safety requirements
- Lead and support regulatory inspections for areas of responsibilities including develop playbooks for the inspections
- Apply lean principles, strategic thinking and organizational design to maximize departments efficiency and agility
- Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.
- Provide exceptional services to plants and site and inform key stakeholders across global operations network during critical activities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Doctorate degree and 2 years of Manufacturing & Operations experience Or
Masters degree and 6 years of Manufacturing & Operations experience Or
Bachelors degree and 8 years of Manufacturing & Operations experience And 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Demonstrated managerial experience in a GMP manufacturing plant, preferably a drug substance plant and mammalian cell culture.
- Demonstrated experience in applying Operational Excellence and Lean Manufacturing
- Cross-functional work experience in either Process Development, Quality or Engineering
- Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
- Demonstrated ability to forge and maintain strong relationships with other functional areas
- Ability to effectively develop and coach staff and positively advance the culture of an organization.
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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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, Puerto Rico and Canada 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.