This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Scientist What you will do Let's do this. Let's change the world. In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project support, integrating effective cross-functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen's pipeline.
Job Responsibility:
Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
Design, plan, complete, and document formulation and process development studies
Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
Lead cross functional initiatives enhancing Pivotal Drug Product platforms
Manage and contribute to process design improvement projects
Ability to travel domestically and internationally up to 10% of the time
Requirements:
Doctorate degree PhD OR PharmD OR MD
OR Master's degree and 3 years of Scientific experience
OR Bachelor's degree and 5 years of Scientific experience
Nice to have:
Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field
Experience in pharmaceutical development and manufacturing
Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
Experience with development and characterization of formulations and drug product manufacturing processes
Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
Critical thinking, problem solving and independent research skills
Strong project management skills, including the ability to manage one's project resources (material, workforce, time, etc.)
Good organizational skills with strong attention to detail
Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally
What we offer:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts