About the role

AI summarised

The Senior Manager Manufacturing (API) at Amgen Singapore Manufacturing leads a team responsible for validation services, manufacturing execution, and continuous improvement for active pharmaceutical ingredient (API) production. The role involves overseeing commissioning, qualification, cleaning validation, and validation maintenance, while ensuring compliance with GMP and regulatory standards. The position requires strong leadership, technical expertise in manufacturing systems, and the ability to drive cross-functional collaboration and regulatory readiness.

BiotechOnsiteManufacturing

Key Responsibilities

Lead a team of professionals to provide validation services for systems associated with the manufacture of active pharmaceutical ingredient (API) drug substance
Supervise and develop professionals in managing, planning, and implementation of changes
Resolve process interruptions and drive deviation investigations
Drive associated continuous improvement efforts
Establish compliant validation strategies and procedures to align with Amgen operation standards and regulatory expectations
Manage and schedule production, maintenance, commissioning, and validation activities
Provide expectations and coaching for performance and development of Amgen Staff
Represent validation and manufacturing execution for regulatory inspections

Requirements

Experienced in employing a risk-based and science-based approach to the specification, design, and verification of manufacturing systems and equipment
Proven ability to lead and develop teams in a GMP manufacturing environment
Strong background in validation services, including commissioning, qualification, cleaning validation, and validation maintenance
Experience in managing and scheduling production, maintenance, commissioning, and validation activities
Demonstrated skill in driving deviation investigations and continuous improvement initiatives
Ability to establish compliant validation strategies and procedures aligned with regulatory expectations
Experience in cross-functional interactions with key site functions to ensure success in validation, production, and release performance
Proven capability to represent validation and manufacturing execution during regulatory inspections
Strong leadership skills with experience in performance coaching and staff development
Ability to make sound judgments and escalate issues under minimal supervision
Knowledge of GMP manufacturing and regulatory expectations in the pharmaceutical industry
Experience in tactical and strategic teamwork within a global manufacturing network