Specialist Stability

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. 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.

Let’s do this. Let’s change the world. In this vital role you will be an individual contributor providing critical support to a Product Quality Team (PQT) by managing the stability program for late stage clinical and commercial products and providing data management support for additional aspects of the PQT and regulatory reporting. The Specialist Stability builds and monitors product stability studies within compliant GMP quality systems (e.g., LIMS, Veeva), organizes and manages product quality and stability data, serves as a primary author on regulatory filing sections, and supports site-based GMP inspections. In addition, the Specialist Stability may provide business process support, such as authoring standard operating procedures (SOPs) or supporting the development of electronic data management tools (e.g., Spotfire applications). Expertise in GMP compliance, project management, time management and successful communication and navigation skills for matrixed team environments are essential. The role is based at the Amgen facility in Hyderabad, India.

• Complete transactions in relevant GMP computer-based systems (Veeva, LIMS, etc.)
• Author and maintain GMP technical documents and stability studies in GMP Quality systems (e.g., Veeva and Sample Manager LIMS).
• Provide stability data reports applying electronic GMP reporting tools in applications such as Spotfire and SHINY
• Collate, review, verify, report, and archive GMP data for clinical and commercial products
• Apply attention to detail to ensure accuracy and completeness of stability and batch analysis data for pharmaceutical products
• Adeptly manage time-sensitive activities independently across multiple teams
• Communicate and collaborate with multi-functional teams across multiple sites and time zones to coordinate stability study starts and sample requests
• Participate in audits and inspections across multiple sites
• Collaborate with offshore team to coordinate activities supporting the Annual Product Review and the Annual Report of Minor Changes
• Mentor and train staff, as required

Basic Qualifications:

• Doctorate Degree in a Life Sciences or Engineering field OR
• Master's degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor's degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience

Must-Have Skills:

• Strong scientific data management and organization skills with attention to detail
• Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
• Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills

Good-to-Have Skills:

• Experience managing GMP stability for pharmaceutical products adhering to US FDA and ICH regulations
• Experience working virtually on a multi-functional team in a matrix environment across multiple time zones
• Expertise in computer applications such as Veeva, Spotfire, SHINY
• Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)

Soft Skills:

• Analytical and problem solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.