Specialist Stability

Lets do this. Lets 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