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.
Process Development Scientist-Biological Relevance and Characterization Live What you will do Lets do this.
Lets change the world.
In this dynamic role you will assist with the developing, qualifying and transferring innovative and fit-for-purpose quantitative potency/characterization assays and supporting regulatory submissions.
Responsibilities include: Developing and implementing innovative and fit-for-purpose potency and biological characterization methods for product release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations May lead a team of lab associates to accomplish project results Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions Generating, analyzing, and interpreting analytical data to support product development investigations, and regulatory submissions Participate or contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation Plans and handles the generation of detailed analytical procedures used for product lot release, stability testing, and/or characterization including timelines, achievements, methodological approaches, expected results, and necessary resources Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory driven activities Designing and implementing analytical projects involving method development, qualification, and transfer Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The Science professional we seek is a collaborative partner with these qualifications.
Basic Qualifications: Doctorate degree in Cell Biology, Molecular Biology, Immunology or Biochemistry subject area OR Masters degree & 4 years of Scientific experience OR Bachelors degree & 6 years of Scientific experience Preferred Qualifications: Expertise in cell culture and bioassay development for the quantitative determination of the biological activity of large molecule therapeutics Expertise in cell-based bioassay development (method optimization, qualification, validation, technical transfer) Expertise in immunology preferred Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines Excellent documentation skills, is detail oriented Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines preferred Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization Experience with automation is desirable Thrive 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 Apply now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
careers.amgen.com Join Us If 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.