External Analytical Lead - CDMO Partnerships

Amgen Inc. (IR); Singapore; Remote; SGD 180,000 - 240,000; Full time

Job summary

Amgen Singapore is seeking a Contract Development and Manufacturing Manager—Analytical Lead to shape external analytical strategy for synthetic therapeutics, ensuring regulatory compliance and timely delivery. You will manage CDMOs/CTLs, drive method development and validation, and coordinate with Process Development, Quality, Regulatory, and Supply Chain teams.

The role demands a doctoral or equivalent education with extensive pharma GMP experience, strong project management, and the ability to

Qualifications

• PhD with relevant chemistry or life sciences background and 2 years pharma GMP experience
• Bachelor’s degree in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences with 4 years pharma GMP experience
• Diploma in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences with 8 years pharma GMP experience
• Experience in analytical development, QC, or external analytical oversight within the pharmaceutical/biotech industry
• Experience working with CDMOs, CTLs, or external laboratory networks
• Strong project management and coordination skills
• Understanding of drug development lifecycle from development through commercial supply
• Solid understanding of cGMP, regulatory/CMC requirements, pharmaceutical quality systems

Responsibilities

• Serve as the primary ACDM analytical lead for assigned programs, integrating analytical activities across development, validation, and commercial lifecycle
• Act as the single point of contact for external analytical partners (CDMOs/CTLs), ensuring alignment on scope, timelines, and deliverables
• Lead analytical strategy and execution, including method development, transfer, qualification, and validation, reference standard strategy and lifecycle management, release, and stability
• Drive end-to-end analytical planning and execution in close partnership with internal stakeholders
• Oversee external analytical operations, including proposal development, scope definition, work order execution, performance tracking, and issue resolution/escalation
• Ensure analytical deliverables meet quality, compliance timeline, and cost expectations
• Proactively identify and mitigate analytical risks that may impact program execution
• Establish and maintain strong working relationships with internal and external stakeholders
• Contribute to continuous improvement efforts, including standardization of analytical approaches
• Operate with a high degree of independence while managing multiple priorities

Skills

Analytical development

External analytical oversight

CDMOs/CTLs management

Project management

Cross-functional teamwork

Regulatory knowledge

Communication skills

Change management

Education

Doctoral degree

Bachelor’s degree

Diploma

Job description

Amgen Singapore is seeking a Contract Development and Manufacturing Manager—Analytical Lead to shape external analytical strategy for synthetic therapeutics, ensuring regulatory compliance and timely delivery. You will manage CDMOs/CTLs, drive method development and validation, and coordinate with Process Development, Quality, Regulatory, and Supply Chain teams.

The role demands a doctoral or equivalent education with extensive pharma GMP experience, strong project management, and the ability to