Contract Development and Manufacturing Manager

Amgen; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Amgen Singapore is seeking a Contract Development and Manufacturing Manager to lead external analytical strategy across development, clinical, and commercial programs. You will partner with CDMOs and CTLs to ensure timelines, quality, and regulatory compliance in a fast-paced environment.

This role requires a PhD or MSc (or strong BA/BS with GMP experience) and robust project management, able to translate strategy into execution with internal and external partners.

Qualifications

• External analytical oversight for pharma programs.
• CDMOs/CTLs coordination and management.
• Strong project management and cross-functional collaboration.
• Understanding of drug development lifecycle and regulatory quality systems.

Responsibilities

• Serve as the primary analytical lead for assigned programs across development, validation, and commercial lifecycle.
• Act as the single point of contact for external analytical partners (CDMOs/CTLs) ensuring alignment on scope and timelines.
• Lead analytical strategy including method development, transfer, qualification, validation, and lifecycle management.
• Oversee external analytical operations including proposals, scope, and performance tracking.
• Ensure deliverables meet quality, timeline, and cost expectations; mitigate analytical risks.

Job description

Career Category Manufacturing Job Description Join Amgen 's Mission to Serve Patients At Amgen , our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Contract Development and Manufacturing Manager

What you will do

The Amgen Contract Development & Manufacturing (ACDM) organization is seeking a highly motivated Analytical Lead to drive external analytical strategy and execution across development, clinical, and commercial programs. This role serves as the primary ACDM analytical interface to CDMOs (Contract Development and Manufacturing Organizations) and CTLs (Contract Testing Laboratory), ensuring delivery against timelines, quality standards, and regulatory requirements. This is a critical role within a highly matrixed, global organization supporting a dynamic portfolio of synthetic therapeutics, including peptides. ACDM, within External Supply in Operations, leads external sourcing and manufacturing strategies across the portfolio by leveraging a global network of partners to enable reliable supply and deliver high-quality medicines to patients. The ideal candidate will thrive in a fast-paced, analytically driven environment and bring strong experience in analytical development and/or quality control, with the ability to translate technical strategy into execution across internal teams and external partners. Strong relationship management skills are essential. Experience supporting commercial analytical readiness, release, and lifecycle management is a plus.

Key responsibilities of this role include:

• 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 (Process Development, Attribute Sciences, Quality, Supply Chain, Regulatory, etc.)
• 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, validation readiness, or product release
• Establish and maintain strong working relationships with internal and external stakeholders, driving effective communication and cross-functional alignment
• Contribute to continuous improvement efforts, including standardization of analytical approaches, governance, and external engagement models
• Operate with a high degree of independence while managing multiple priorities, programs, and business processes

All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

What we expect of you

• Doctorate Degree Master's degree in in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences and 2 years of experience in pharmaceutical company or GMP environment
• OR Bachelor's degree in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences and 4 years of experience in pharmaceutical company or GMP environment
• OR Diploma in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences, and 8 years of experience in pharmaceutical company or GMP environment
• Experience in analytical development, QC, or external analytical oversight within the pharmaceutical or biotechnology industry
• Experience working with CDMOs, CTLs, or external laboratory networks, including managing external partner relationships
• Strong project management and coordination skills, with the ability to manage multiple priorities and workstreams simultaneously
• Understanding of drug development lifecycle, from development through commercial supply
• Solid understanding of cGMP, regulatory/CMC requirements, and pharmaceutical quality systems
• Experience with synthetic therapeutics (small molecules, peptides, or oligonucleotides) preferred
• Self-starter with a high-level of comfort