Biologics Process Development Lead — MSAT & Tech Transfer

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

Job summary

Amgen is seeking a Senior Manager in Process Development (MSAT) to drive biologics technology transfer, process validation, and new technology implementation. You will lead a team, coordinate cross-functional activities, and ensure alignment with regulatory expectations.

The role emphasizes site optimization, lifecycle management, troubleshooting, and strong collaboration with DST and drug substance teams. A robust background in cGMP biopharma and stakeholder communication is required.

Qualifications

• PhD/MD or equivalent with biologics process development or commercial-scale technical support.
• Master’s degree with 6+ years of biologics process development or commercial-scale technical support.
• Bachelor’s degree with 8+ years of biologics process development or commercial-scale technical support.

Responsibilities

• Lead biologics technology transfer, process validation, and new technology evaluation/implementation.
• Lead site activities for process optimization, complex investigation, and product lifecycle management.
• Manage a team of direct reports in Process Development and collaborate across functions.
• Coordinate with cross-functional and network drug substance teams to troubleshoot complex challenges.
• Deliver site goals while ensuring quality, schedule, and cost objectives.
• Ensure safety and compliance of process development and manufacturing activities.
• Support regulatory filings, audits, inspections, and other CMC activities.
• Contribute as a DST leadership team member to advance capabilities.

Skills

Cell culture expertise

Purification processes

Oral & written communication

Statistical analysis

Analytical methods

Product quality attributes

Regulatory knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen is seeking a Senior Manager in Process Development (MSAT) to drive biologics technology transfer, process validation, and new technology implementation. You will lead a team, coordinate cross-functional activities, and ensure alignment with regulatory expectations.

The role emphasizes site optimization, lifecycle management, troubleshooting, and strong collaboration with DST and drug substance teams. A robust background in cGMP biopharma and stakeholder communication is required.