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Scientist, Process Development

Cambridge, MA 02138
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Job ID: R-114444
Location: Cambridge, MA, US

The Materials Science team within Attribute Sciences provides technical expertise and oversight of risk analysis for raw materials used to manufacture Amgen's pipeline and portfolio of large and small molecule therapies. The successful candidate will be responsible for providing subject matter expertise in the preparation, characterization, and performance of the materials used in the manufacturing of Amgen's portfolio of large and small molecule therapies. The scientist will perform a range of cross-functional activities such as support for the development of attribute-driven material specifications, the selection of materials based upon an understanding of how the material attributes impact process performance and product quality, the evaluation of material related risks and technical assessments for investigations. This role will involve building and maintaining effective cross-functional collaborations with peers throughout Amgen's Raw Material Network, Quality, Process Development, Regulatory Affairs, and Manufacturing to ensure uninterrupted supply of quality raw materials to Amgen.

Core job responsibilities include:
Lead the initiative to identify the attributes of chemicals, media, and excipients most critical to process performance and product quality outcomes.

Facilitate the use of attribute knowledge for investigations and raw material control strategy development.

Oversee efforts to understand and mitigate raw material variability to proactively prevent impact on manufacturing process performance.

Collaborate with external suppliers to understand the technical aspects of raw material manufacturing process and strategies for controlling raw material attributes.

Provide technical assessments of the impact of supplier changes to raw material attributes

Support root cause investigations, evaluation of supplier responses, and effectiveness verification of corrective/preventative actions
Maintain awareness of global pharmacopeia requirements for raw materials and their impact on Amgen's portfolio. Collaborate on the development of scientific strategies for handling updates to raw material pharmacopeia monographs.
Participate in external scientific engagements to represent Amgen's position on raw material topics in the industry.

Basic Qualifications

Doctorate degree
Master's degree and 4 years of Scientific experience
Bachelor's degree and 6 years of Scientific experience

Preferred Skills and Experience
Excellent communication skills (written and oral), including the ability to explain technical topics to non-technical colleagues
Ability to collaborate effectively and work in teams.

Understanding of chemical synthesis, chemical manufacturing unit operations, and purification strategies.

Knowledge of the function of different chemicals, media components, and excipients in pharmaceutical manufacturing
Excellent analytical/problem-solving skills
Good organizational skills

Be able to multi-task and function in a dynamic environment
Ability to work with technical documents, perform data analysis, and identify critical missing information

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



Posted: 2021-03-14 Expires: 2021-04-14

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Scientist, Process Development

Cambridge, MA 02138

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