Auto req 13787BR
Job Posting Title Sr Associate Scientist
Career Category Process Development
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description Seeking a highly motivated individual to function as a member of a commercial (drug product) process development team, focused on providing support to technology transfers, process characterization and commercial manufacturing. Position will perform experiments, organize data and analyze results with minimal supervision. Evaluation of product impact due to process variables will be a critical deliverables for this role. Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods is a need for this role. The position will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate data to the cross functional group. Experience with root cause analysis and technical investigations in the fill/finish area is a plus. Cross functional teamwork will be a critical component of this job. Regular interactions with Quality and Regulatory functions are expectations for this role. Effective communication skill is a requirement with the ability to exert influence a plus for this role.
Basic Qualifications • Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience
Preferred Qualifications • Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Sciences or related field.
• 2+ years experience within the pharmaceutical/biotechnology industry; Experience to include understanding of physical / chemical stability of proteins, and interpreting results from various analytical methods on proteins. Process characterization, scale-up, and/or technology transfer experience.
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.
• Familiarity with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing.
