External Analytical Lead - CDMO Partnerships

Amgen Inc. (IR); Singapore; Remote; SGD 240,000 - 320,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Amgen Inc. (IR) is seeking an Analytical Lead within Contract Development and Manufacturing to drive external analytical strategy across development, clinical, and commercial programs.

You will act as the primary interface to CDMOs and CTLs, ensuring timely, compliant, and cost-effective analytical execution in a global, matrixed environment. The role emphasizes partnership with Process Development, Quality, Regulatory, and Supply Chain, with a focus on method development, transfer, validation,

Qualifications

• Pharma/GMP experience with analytical development, QC, or external oversight.
• Experience working with CDMOs, CTLs, or external laboratory networks.
• Strong project management and coordination across multiple workstreams.
• Understanding of drug development lifecycle and regulatory CMC requirements.

Responsibilities

• Serve as the primary ACDM analytical lead for assigned programs across development, validation, and commercial lifecycle.
• Act as single point of contact for external analytical partners, aligning scope, timelines and deliverables.
• Lead analytical strategy including method development, transfer, qualification, and validation.
• Drive end-to-end analytical planning with internal stakeholders (Process Development, Quality, Regulatory, Supply Chain).
• Oversee external analytical operations, including scope definition, scope, work orders, tracking, and issue resolution.
• Ensure deliverables meet quality, regulatory, and cost expectations.
• Identify and mitigate analytical risks impacting program execution and product release.
• Maintain strong relationships with internal and external stakeholders for cross-functional alignment.

Skills

Analytical lead

Cross-functional collaboration

Project management

External partnership management

Regulatory / CMC knowledge

Education

Doctorate degree or Master’s in Chemistry/Engineering/Life Sciences

Bachelor’s degree with 4+ years in pharma/GMP

Diploma with 8+ years in pharma/GMP

Job description

Amgen Inc. (IR) is seeking an Analytical Lead within Contract Development and Manufacturing to drive external analytical strategy across development, clinical, and commercial programs.

You will act as the primary interface to CDMOs and CTLs, ensuring timely, compliant, and cost-effective analytical execution in a global, matrixed environment. The role emphasizes partnership with Process Development, Quality, Regulatory, and Supply Chain, with a focus on method development, transfer, validation,