Process Development Associate

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** Career Category
** Scientific####
** 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. 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.
** Process Development Associate**##
** What you will do
** Let's do this. Let's change the world. In this vital role you join will the pivotal synthetic Attribute Sciences team, part of the integrated Pharmaceutical Attribute Sciences (iPAS) department, located in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.

The analytical scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs across small molecules, synthetic peptides, siRNA, and synthetic components of conjugates. The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.
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* Key Responsibilities:

*** Hand-on experience in sample preparation and analysis of synthetic in-process samples, lot release samples, and drug product formulations using primarily chromatographic and spectroscopic techniques.
* Under the guidance of a supervisor, apply established methodologies and techniques to execute and validate analytical methods for testing drug substances and drug products across synthetic modalities, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody-drug conjugates (ADCs).
* Organize and document analytical data under Good Documentation Practice using electronic laboratory notebook system.
* Provide and present results in consultation with supervisor to support drug substance and drug product development.
* Transfer analytical methods to contract manufacturing or contract testing labs.##
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.
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* Basic Qualifications:

*** Bachelor's degreeOR
* Associate's degree and 2 years of Scientific experience OR
* High school diploma / GED and 4 years of Scientific experience
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* Preferred Qualifications:

*** Bachelor's degree in Analytical Chemistry, Organic Chemistry, Physical, Pharmaceutical, Life Sciences, Engineering, or relevant.
* Strong analytical experience with small molecules, synthetic peptides, siRNA, and/or antibody-drug conjugates, combining scientific knowledge, research capability, and hands-on laboratory expertise to support process development, scale-up, and formulation development activities.
* Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation, especially chromatographic (e.g. liquid chromatography and gas chromatography) and spectroscopic instruments (e.g. mass spectrometry).
* Experience in laboratory settings within the pharmaceutical or biotech industry
* Technical aptitude for identification, development, and implementation of novel analytical technologies, such as mass spectrometry (MS), vibrational spectroscopy, or nuclear magnetic resonance (NMR) etc.
* Knowledge of related regulatory/industry considerations,…