Biologics Process Development Lead – Tech Transfer

Amgen Inc. (IR); Singapore; On-site; SGD 180,000 - 260,000; Full time

Job summary

Amgen is seeking a Senior Manager, Process Development (MSAT) in Singapore to lead biologics tech transfer, process validation, and new technology evaluation. You will guide site activities for process optimization, investigations, and lifecycle management while collaborating with cross-functional teams to meet safety, quality, and cost objectives.

With 8+ years in biotech processes and 2+ years in management, you will drive regulatory readiness, support filings, and contribute to DST leadership

Qualifications

• PhD with 2+ years biologics process development or MS with 6+ years or BS with 8+ years in biologics/process development.
• 8+ years in a technical role supporting biotechnology processes in regulated environments (cGMP) with 2+ years of management.
• Deep expertise in cell culture and/or purification processes.
• Experience in process scale-up, technology transfer, process validation, troubleshooting and complex investigations.
• Strong oral and written communication with diverse stakeholders.
• Knowledge of regulatory filings and inspections.
• Familiarity with commercial biopharma manufacturing operations.
• Familiarity with statistical analysis and analytical methods related to biological processing.

Responsibilities

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

Skills

Biologics process development

Cell culture

Purification processes

Process scale-up

Technology transfer

Process validation

Troubleshooting

Complex investigation

Communication skills

Regulatory filings

Statistical analysis

Analytical methods

Product quality attributes

Education

Doctorate degree in Biologics

Master’s degree in Biologics

Bachelor’s degree in Biologics

Job description

Amgen is seeking a Senior Manager, Process Development (MSAT) in Singapore to lead biologics tech transfer, process validation, and new technology evaluation. You will guide site activities for process optimization, investigations, and lifecycle management while collaborating with cross-functional teams to meet safety, quality, and cost objectives.

With 8+ years in biotech processes and 2+ years in management, you will drive regulatory readiness, support filings, and contribute to DST leadership