Process Development Associate Scientist

Process Development Associate Scientist page is loaded## Process Development Associate Scientist remote type:
Flex Commuter / Hybrid locations:
US - Massachusetts - Cambridge time type:
Full time posted on:
Posted Todayjob requisition :
R-232597##
** Career Category
** Process Development## ##
** Job Description
**** 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.
** Process Development Associate Scientist
**** What you will do and what we expect of you
** Let’s do this. Let’s change the world. In this vital role you will:
** Duties:
** Apply phase-appropriate GMP principles to ensure compliance and high-quality documentation in support of late-stage development activities;
Conduct in-depth analysis of late-stage protein-based therapeutics using advanced analytical techniques, including capillary electrophoresis (CE-SDS), Chromatography (HPLC/UPLC), HIAC (Sub-visible particle testing), capillary isoelectric focusing (CIEF), cation exchange chromatography (CEX), size-exclusion chromatography (SEC), hydrophilic interaction chromatography (HILIC), hydrophobic interaction chromatography (HIC), Spectrophotometer, reverse phase chromatography (RP) and mass spectrometry (MS);
Support the development, optimization, and troubleshooting of separation-based purity methods. Contribute to method qualifications, transfers, and validation studies to ensure robust analytical performance;
Hands-on experience with CE and LC instrumentation, including maintenance and troubleshooting to ensure consistent operational performance;
Use analytical data processing software such as Empower, as well as electronic laboratory notebooks (ELNs) for documentation, technical protocol development, and report authorship;
Provide training, troubleshooting support, and oversight of analytical workflows executed by Rapid Analytics contract staff;
Perform and monitor assay control charts to assess the ongoing performance of analytical testing conducted by the Rapid Analytics team.
** Requirements:
** Master’s degree (or foreign equivalent) in Food Science, Chemistry, Biochemistry, Biotechnology or related field and completion of a university-level course, research project, internship, thesis, or one year of experience in the following:
1. Capillary electrophoresis (CE-SDS), High pressure & Ultra high pressure liquid chromatography (HPLC/UPLC), mass spectrometry (MS), and various chromatography methods including Cation exchange (CEX), Size exclusion (SEC), Hydrophilic interaction liquid (HILIC), Hydrophobic interaction (HIC) and Reverse phase (RP);2.

Experience with Capillary electrophoresis (CE) and Liquid chromatography (LC) instruments, including maintenance, troubleshooting, and ensuring operational performance;
3. Data processing software including Empower and experience with electronic laboratory notebooks (ELNs) for data documentation and analysis;
4. Understanding of phase-appropriate GMP compliance and documentation practices and contribute to method qualifications and transfers in late-stage protein therapeutics development;
5. Experience in providing training, troubleshooting support, and oversight of analytical workflows, ensuring quality control;6. and  Spectrophotometer and Spectroscopy like Ultraviolet and fluorescence detectors.
** Contact:
** Interested…