Scientist

Amgen•Cambridge, MA

20h•Remote

About The Position

Join Amgen’s Mission of Serving Patients 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. 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.

Requirements

Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, or related field and 3 years of experience in the job offered or in a chemistry-related occupation.
Developing, executing, and troubleshooting analytical test methods utilizing high performance liquid chromatography;
Qualifying and transferring analytical test methods following pharmaceutical industry guidelines;
Operation and data analysis with chromatography data software such as Waters Empower, Agilent Chemstation, or OpenLab;
Investigating out of trend and out of specification analytical test results;
Training analysts on the operation of high-performance liquid chromatography equipment and the interpretation of chromatography data for biological and small molecule drug candidates;
Executing analytical tests in accordance with the United States or international pharmacopoeia.

Responsibilities

Provide training, troubleshooting, and oversight of high performance liquid chromatography (HPLC) analyses; Analyses include size-exclusion, cation and anion exchange, affinity, and reversed phase high performance liquid chromatography and/or ultra high performance liquid chromatography (UHPLC);
Perform hands-on testing support of the HPLC/UHPLC methods;
Implement new HPLC/UHPLC methods including, drafting test method standard operating procedures, performing familiarization runs, and documenting method establishment in method transfer reports;
Perform and trend assay control charts to monitor the performance of all HPLC/UHPLC testing;
Interface with analytical method developers and team leads on method performance;
Perform technology development to improve the speed and compliance;
Qualify HPLC/UHPLC methods to enable transfer of methods to a quality control laboratory;
Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.
Supervises direct reports.