Process Development Principal Scientist

** 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 Principal Scientist*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will head the research and development efforts related to manufacturing processes. They design, conduct, and interpret experimental studies and develop novel methodologies to improve efficiency and quality.

+ Serves as the Attribute Sciences Representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.

+ Leads and drives the analytical assessment of a Pre-pivotal candidate biotherapeutic through development.

+ Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.

+ Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.

+ Evaluates analytical method performance and reliability, including the impact of proposed method changes.

+ Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.

+ Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.

+ Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.

+ Stays current in the field and evaluates emerging analytical technologies.

** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

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* Basic Qualifications:

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* Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience

OR

Master's degree and 5 years of Scientific experience

OR

Bachelor's degree and 7 years of Scientific experience

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* Preferred Qualifications:

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* + Ph.D. in biochemistry, analytical chemistry, biophysics, pharmaceutical chemistry or a related life science field, with 2 years of industry experience.

+ Strong leadership skills and ability to communicate in a team environment succinctly and effectively.

+ Deeply critical thinking with a creative and problem-solving mindset.

+ Highly knowledgeable in protein biochemistry and protein-based biotherapeutics.

+ Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics.

+ Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.

+ Familiarity with common biotherapeutic critical quality attributes, such as aggregation, fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their…