Process Development Sr Associate

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.

Duties:
Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms;
Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography
- Mass Spectrometry (LC-MS) studies to support product characterization and comparability studies;
Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods;
Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment;
Focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions;
Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways;
Perform evaluation of novel platform analytical technologies to help drive innovation; and Perform experiments to help answer questions from health authorities; and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.

Requirements:
Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation. Position requires 2 years of experience in the following:

• Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software:
  Empower, Chromeleon, and Chem Station;
• Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;
• Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including:
  High Performance Liquid Chromatography (HPLC), Liquid Chromatography
  - Mass Spectrometry (LC-MS), Solo Variable Path length Extension (SoloVPE), and Capillary Electrophoresis (CE);
• Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;
• Application analytical instrument troubleshooting across different platforms:
  Waters, Agilent, and Maurice;
• Analytical deliverables for pharmaceutical processes and product development;
• Data analysis, statistical analysis and method qualifications and transfers;
• Technical knowledge of proteins…