Senior Manager Process Development (MSAT)

About the role

Amgen is hiring a Senior Manager Process Development (MSAT) at its Singapore manufacturing site in Tuas. The role applies process engineering expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes, leading projects, managing a team and collaborating with cross-functional and network drug substance teams.

Key responsibilities

• Lead projects on biologics technology transfer, process validation and new technology evaluation and implementation.
• Lead site activities for process optimization, complex investigation and product life cycle management.
• Manage a team of direct reports in the Process Development group and key projects or business processes across functions.
• Collaborate with cross-functional and network drug substance teams to solve complex challenges using advanced technical principles.
• Deliver site goals while meeting quality, schedule and cost objectives.
• Ensure safety and compliance of process development and/or manufacturing activities.
• Support regulatory filings, audits and inspections, and other CMC activities.
• Serve as a member of the Drug Substance Technology (DST) extended leadership team.

Required profile

• One of: doctorate with 2 years of biologics process development or commercial-scale technical support experience, master's with 6 years, or bachelor's with 8 years of such experience.
• 8+ years of experience in a technical role supporting biotechnology processes in regulated (cGMP) environments, and 2+ years of management experience.
• Strong oral and verbal communication skills and ability to work with diverse internal and external stakeholders.
• Knowledge of regulatory filings and inspections, and familiarity with commercial biopharma manufacturing operations.
• Familiarity with statistical analysis, analytical methods and product quality attributes related to biological processing.
• Selection is subject to fulfilling the medical requirements of the job scope.

Required skills

• In-depth expertise in cell culture and/or purification processes.
• Experience in process scale-up, technology transfer, process validation, troubleshooting and complex investigation.