Stability Specialist I

Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit www.amgen.com.

Amgen is committed to promoting and maintaining an inclusive, high-performing culture where all team members embrace and leverage each others' talents and backgrounds, nourish innovative thinking, achieve their full potential, and contribute to Amgen's success. Our commitment to diversity is articulated in our core values and reflected in every part of our organization. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace.

As a member of the AWA Stability team you will be required to act as the stability representative in support of therapeutic product commercialization. Stability representative job responsibilities involve:

Demonstrating technical expertise by reviewing, interpreting and approving stability data.
Participate in and support the development of product specific stability strategies for Amgen Washington's clinical therapeutics.
Preparing accurate and timely internal and external reports for clinical and commercial biopharmaceutical products.
Designing scientifically sound stability studies to ensure regulatory compliance at each stage of the products development life cycle. (Tox, phase I, through commercialization)
Author stability sections for IND and BLA regulatory filings.
Work within multidiscipline teams to support and develop commercialization timelines.
Perform special projects as assigned by management.
REQUIREMENTS
Bachelor's degree in Life Sciences is required. At least 5-8 yrs of relevant industry experience as a strong team player within either the quality or analytical development areas. Strong presentation/project management skills are required to handle the multiple product/projects activities within the Stability group. Ability to work with internal teams as well as contract manufacturers and/or testing labs. Experience in regulatory submissions and inspections preferred.