HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Lets do this. Lets change the world. In this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies, and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating on projects, issue resolutions and investigations. You will work closely with diverse functional groups including: Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development.
The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality/stability data, may serve as a primary author on regulatory filings, and also directly participates in & supports site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successful navigation skills for matrixed team environments are essential.
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.Key Responsibilities include:
- Build and maintain technical GMP documents and product stability studies
- Review, verify, report, and archive GMP data for clinical and commercial products
- Apply keen attention to detail to conduct data review and reports
- Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
- Adeptly manage time-sensitive activities independently
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The expert professional we seek is a strong communicator with these qualifications.
- Doctorate degree OR
- Masters degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Bachelors degree & 5 years of Quality, Operations, Scientific, and/or Manufacturing experience OR
- Associates degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR
- Highschool diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience
- B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
- Experience working in a regulated environment (either direct GMP or technical support)
- Strong project management skills
- Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
- General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
- Experience working on a cross-functional team in a matrix environment
- Excellent written and verbal communication skills, including facilitation and presentation skills
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.