PD Attribute Sciences Scientist
HOW MIGHT YOU DEFY IMAGINATION?
How will you use that achievementsto 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.
PD Attribute Sciences Scientist
What you will do
Lets do this! Lets change the world! There an exciting career opportunity to join the Commercial Attribute Sciencesteamwithin the Process Development organizationat the Amgen Rhode Island site. In this role as aScientist, you will:
Lead a team of scientists to provide technical oversight in support of method related testing challenges, incoming method transfer and commercial investigations spanning various analytical platforms which may include chromatography, CE, DNA, and immunoassays used to test diverse modalities.
Schedule and prioritizeworkfor the teamacross a wide range of customers.
Responsible forsupportingtheimplementation of new analytical technology, incoming tech transfer, analytical support for the Drug Substance Technology group.
Apply established platform approaches and problem-solving skills to rapidly tackle challengesspanning various analytical platforms
Interact and collaborate with multiple functional areas in matrix environment, both at site and network levels.
Interpret results, author and review technical reports and assessments.
Work closely with process engineers and quality control laboratories to generate and interpret analytical data to provide guidance around process understanding and control
Support process improvements, including analytical comparability, small-scale model support
Providing expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Other duties include maintenance of electronic notebook records of experimental data, participation in authoring of technical protocols and reports, and presentation of results in internal meetings
Support career development and mentor staff.
Keep current in the analytical development field including literature and technology development for cutting edge and regulatory driven 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.
Masters degreeand4years of Scientific or Operations experienceOR
Bachelors degree and6years of Scientific or Operations experience
PhDin Biochemistry, Biomedical, Life Sciences or closely related field
5+years of scientific experience providing and driving analytical deliverables for biopharmaceutical processes and product development
Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing usingchromatography and mass spectrometry methods
Deep understanding of product quality attributes for biologics, their control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
Experience managing and transferring commercial production and test methods.
Experience in data analysisandstatistical analysis
Experience in applying troubleshooting and investigation methodologies for problem solving
Experiencewith regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
Familiarity with biopharmaceutical manufacturing processes
Familiarity with forensics analysisand investigations
Familiarity with lean concepts and 5S
Ability to independently manage and prioritize multiple tasks as well as work as part of a team
Motivated self-starter with excellent interpersonal and organizational skills
Demonstrated ability to deliver on complex and challenging objectives in defined timelines
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.