Senior Scientist - Global Biosimilars
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. Join us.
Senior Scientist - Global BiosimilarsLive
What you will do
Lets do this. Lets change the world. In this vital role you will Amgen is looking for a Senior Scientist with a positive leadership style to join the collaborative and fast-paced Biosimilars Functional Similarity team at the Amgen headquarters campus located in Thousand Oaks, CA. This team is responsible for delivering comprehensive in vitro and in vivo functional similarity testing plans to support Amgens biosimilars development. The Senior Scientist will be responsible for designing and executing the strategies to deliver high-quality functional similarity packages that meet the expectations of global regulators and balance feedback from current Amgen programs as well as competitor biosimilars across multiple therapeutic areas.
Day to day responsibilities include:
Crafting the similarity strategy to support the assessment of non-clinical in vitro pharmacology across multiple biosimilar programs. The development of a successful nonclinical similarity testing strategy includes detailed understanding of the mechanism(s) of action of the molecule, and evaluating the potential impact to clinical efficacy, pharmacokinetics, or safety. A strong ground in the biology of large molecules, in vitro, in vio and ex vivo knowledge are required. Part of the role entails guiding fit-for-purpose assay qualification to support a rigorous testing plan.
Managing efficiently and executing the plan with internal and external partners. This role uses a breadth of communication expertise, both written and oral, across a broad range of stakeholders, influencing decision-making through negotiation and delivering results by building productive working relationships across functional areas within the company.
Leading external interactions and collaborations with partners in academia and at contract research organizations to deliver results that fulfill the regulatory requirements for biosimilar development.
Supporting multiple programs through the regulatory approval process in numerous jurisdictions through authoring of filing documents, participating in face to face discussions with regulators, and ensuring maintenance of appropriate documents in a compliant manner.
Additional responsibilities include generation of abstracts, posters and publications and participating in domestic and international scientific meetings.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.
Doctorate degree and 2 years of Scientific experience
Masters degree and 5 years of Scientific experience
Bachelors degree and 7 years of Scientific experience
PhD in Immunology, Immuno-oncology or Pharmacology with 6+ years experience in the Biotechnology/Pharmaceutical Industry
Experience in discovery and research areas with in vitro and ex vivo assays as well as in vivo studies
Excellent interpersonal skills and leadership experience with strong decision making and problem-solving skills
Experience critically designing and evaluating biological assays to query diverse biology, particularly in the fields of immunology and/or oncology
Excellent oral and written communication skills, including presentations to senior management and external regulatory authorities
Proven track record of independent critical thinking and scientific achievement in research, exemplified by a strong publication record
Experience with SPR technologyThrive
What you can expect of us
As we work to develop treatments that take care of others, so we 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.