Process Development Sr 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 Sr Scientist*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role, you will join Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization. AS defines the favorable quality characteristics of the therapies Amgen produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organization's focus is developing and commercializing robust manufacturing processes across a wide range of biologic therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers ("BiTEs"), and antibody-drug conjugates (ADCs).

Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

+ Supervise and provide technical support for a team that provides analytical support for late stage product development

+ Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program

+ Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control

+ Manage activities at contract manufacturing and testing sites

+ Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities

+ Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification

+ Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development

+ Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

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

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* Basic Qualifications:

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* Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

OR

Master's degree and 3 years of Scientific experience

OR

Bachelor's degree and 5 years of Scientific experience

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* Preferred Qualifications:

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* · Doctorate degree with 5 years in Analytical Chemistry,…