Senior Biologics Process Development Lead

Amgen; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Amgen in Singapore seeks a Senior Manager of Process Development (MSAT) to lead biologics tech transfer, process validation, and new technology evaluation. You will manage a team, drive site-wide process optimization, and collaborate with cross-functional teams to ensure quality and regulatory readiness.

The role requires extensive biologics process development experience in regulated environments, strong leadership, and excellent communication with stakeholders.

Qualifications

• Doctorate with 2 years biologics process development or commercial-scale support
• Master’s with 6 years biologics process development or commercial-scale support
• Bachelor’s with 8 years biologics process development or commercial-scale support
• 8+ years in biotech processes in regulated (cGMP) environments and 2+ years of management
• Strong expertise in cell culture and/or purification processes
• Experience in scale-up, tech transfer, validation, troubleshooting, investigations
• Strong communication and stakeholder management
• Regulatory filings & inspections knowledge
• Familiarity with commercial biopharma manufacturing operations
• Familiarity with statistical analysis and product quality attributes

Responsibilities

• Lead projects on biologics technology transfer, process validation and new tech evaluation/implementation.
• Lead site activities for process optimization, complex investigations, and product lifecycle management.
• Manage a team of direct reports in Process Development and key cross-functional projects.
• Collaborate with cross-functional and network drug substance teams to troubleshoot complex challenges.
• Deliver site goals while meeting quality, schedule, and cost objectives.
• Ensure safety and compliance of process development and manufacturing activities.
• Provide support for regulatory filings, audits, inspections, and other CMC activities.
• Serve on the DST extended leadership team to advance drug substance capabilities.

Education

Doctorate degree with 2 years biologics process development or commercial-scale technical support experience

Master’s degree with 6 years biologics process development or commercial-scale technical support experience

Bachelor’s degree with 8 years biologics process development or commercial-scale technical support experience

8+ years in a technical role supporting biotechnology processes in regulated environments (cGMP) and 2+ years of management

Strong and in-depth expertise in cell culture and/or purification processes

Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation

Strong oral and verbal communication skills; ability to interact with diverse stakeholders

Knowledge of regulatory filings and inspections

Familiarity with operational aspects of commercial biopharma manufacturing

Familiarity with statistical analysis, analytical methods, and product quality attributes related to biological processing

Job description

Amgen in Singapore seeks a Senior Manager of Process Development (MSAT) to lead biologics tech transfer, process validation, and new technology evaluation. You will manage a team, drive site-wide process optimization, and collaborate with cross-functional teams to ensure quality and regulatory readiness.

The role requires extensive biologics process development experience in regulated environments, strong leadership, and excellent communication with stakeholders.