Senior Associate Manufacturing -Process Owner
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 Associate Manufacturing- Process OwnerLive
What you will do
Lets do this. Lets change the world. In this vital role you will work in one the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations. Amgens new plant, AR30, is responsible for drug substance manufacturing and release of Amgens commercial product using innovative single use manufacturing platforms and technologies. We are looking for a talented Senior Associate Manufacturing to joining the manufacturing technical support function, initially to help with startup operations for our Next Generation Bio-manufacturing plant.
This individual contributor position reports into the Downstream Manager of the AR30 Manufacturing Support Team and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects.
The focus of this role will be collaboration with the AR30 team to support the facility for commercial operations. This includes and is not limited to supporting manufacturing operations team, SOPs, major deviations, raw materials deviations, CAPAs, EVs, change controls, electronic batch records, job hazards analysis, improvement projects and standard work and, improvement projects, and participating in NPIs and PRIs.
Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing area. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations. Senior Associate Manufacturing may participate in cross-functional teams and represent the Purification groups. Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Unit operations, SOPs, CAPAs, Change controls and Deviations. In addition, Senior Associate Manufacturing will identify, recommend, and implement improvements related to routine floor operations in solution preparation, cell culture and purification.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a collaborative partner with these qualifications.Basic Qualifications
- Masters Degree OR
- Bachelor's degree with 2 years of manufacturing experience Or
- Associate degree and 6 years of Manufacturing or Operations experience Or
- High School diploma/GED and 8 years of Manufacturing or Operations experience.
- Single use technology experience
- Cell Culture Experience and/or Purification experience
- Regulatory knowledge and experience with regulatory audits
- Ability to interpret and apply GMP knowledge
- Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
- Mechanical expertise
- Knowledge of WIP lab equipment and computers, with LIMS access
- Basic statistical and mathematical skills
- Understanding of analytical methods for manufacturing area
- Ability to demonstrate technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on Manufacturing equipment including single use equipment
- Experience with Delta V/MES
Some of the vast rewards of working here
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.
- 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, 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.