Sr Associate Contract Development & Manufacturing

Amgen is seeking a Sr Associate Contract Development & Manufacturing for their site in Hyderabad, India. The role provides oversight of New Product Introductions, technical support to the manufacturing team, and the implementation of improvements to enhance efficiency and quality. You will liaise between departments to ensure a smooth manufacturing process and compliance with quality standards, provide information insight and data analysis, and drive execution of transactional and tactical tasks to ensure the Amgen Contract & Development Manufacturing (ACDM) work cell hub’s success. This position adds a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and help ensure an uninterrupted global supply of medicines to patients.

Responsibilities

• Project Management and Technology Transfers: Lead and manage new product introductions and technology transfers to external (third-party) manufacturing organizations. Coordinate cross-functional teams, ensure adherence to business processes, and oversee multiple complex projects. Responsibilities include project planning, budgeting, communication, reporting, and driving continuous improvement initiatives to enhance quality, efficiency, and alignment with company priorities.
• Follow-up and track activities from conception to implementation and close-out. Manage timelines and highlight risks of transfer team activities; coordinate risk management as part of transfers and provide escalation as needed.
• Manufacturing Operations: Ensure accuracy and completion of data entries and tasks for budget development, monitoring, and reporting; manage contract inputs and requirements, confidentiality agreements, scope of work, requests for pricing/information, supply agreements, etc. Own deviations (major/minor) and maintain and monitor systems to ensure deviations are investigated and concluded per quality standards and procedures. Optimize deviations management, corrective and preventive actions, and effectiveness to prevent recurrence.
• Own SICAR, CAPA, CAPA EV, and other complex change control records.
• Site Performance Monitoring: Report contract site performance metrics to the site lead; identify opportunities for site performance improvements. Daily duties include coordination, issuing and reviewing meeting minutes, analyzing data and metrics, driving continuous improvement and standardization of performance tools used by Work Centre Teams (WCT), and overseeing procurement and payment of invoices. Active participation in WCT meetings is expected.

Requirements

• Specific qualifications, experience, and other requirements are not listed in the provided description.