Sr Scientist
Posted on: 19 Mar 2021
Thousand Oaks, CA
Job Description
The Department of Clinical Immunology within the Translational Medicine Organization at Amgen is seeking a highly motivated Senior Scientist to provide immunogenicity support for our protein therapeutic pipeline at the Amgen Thousand Oaks site. In this role, you will provide project and scientific oversight of the immunogenicity component of drug development for a diverse portfolio of Amgen product candidates, including biosimilars. Work closely with Clinical Development team members across sites and functions including Safety, Biomarkers, Translational Sciences and Bioanalytical as well as Therapeutic Discovery.
Position Responsibilities
* Author key regulatory, clinical study, and technical documents.
* Interpret immune response data and assess potential clinical impact
* Apply immunology expertise throughout the drug development process
* Ability to work independently and manage productive cross-functional collaborations
Basic Qualifications
Doctorate Degree with 4 years of postdoc and/or industry experience
Or
Masters degree plus 12 years of scientific experience in immunology
Preferred Qualifications
* Ph.D and research/industry experience in the field of immunology
* In-depth understanding of the innate and adaptive immune system, excellent scientific thinking and problem solving.
* Detailed knowledge of immunology and various bioanalytical assays used to measure the immune response.
* Experience in the clinical development of biologic drugs or vaccines
* Knowledge of immunogenicity risk assessment related to quality attributes
* Familiar with global regulatory guidelines related to immune assessment.
* Excellent communication skills and ability to influence and lead cross-functional teams
* Strong verbal and written communication skills.
* High degree of flexibility to adapt to different projects and shifting priorities.
Amgen Inc.
Oakland, CA
Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, and neuroscience. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta, a pegylated protein to treat cancer patients; Prolia to treat postmenopausal women with osteoporosis; Aranesp to treat anemia; Xgeva for skeletal-related events prevention; Sensipar/Mimpara products to treat sHPT in chronic kidney disease; and EPOGEN to treat a lower-than-normal number of red blood cells.
It also markets other products in various markets, including Kyprolis, Nplate, Vectibix, Repatha, NEUPOGEN, Parsabiv, Blincyto, Aimovig, Imlygic, Corlanor, Kanjintitm, and Amgevitatm. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. The company has collaborative agreements with Novartis; UCB; Bayer HealthCare Pharmaceuticals Inc.; and DaVita Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
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IndustryManufacturing
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No. of Employees21, 500
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Website
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Jobs Posted662
