Contract Development and Manufacturing Manager (Analytical Lead)

About the role

Amgen's Contract Development and Manufacturing (ACDM) organization is seeking an Analytical Lead to drive external analytical strategy and execution across development, clinical and commercial programs. The role is the main ACDM analytical interface with CDMOs and CTLs, ensuring delivery against timelines, quality standards and regulatory requirements. It sits in a matrixed, global organization supporting synthetic therapeutics, including peptides.

Key responsibilities

• Serve as the primary analytical lead for assigned programs, integrating analytical activities across development, validation and commercial lifecycle
• Act as single point of contact for external analytical partners (CDMOs/CTLs), aligning scope, timelines and deliverables
• Lead analytical strategy and execution, including method development, transfer, qualification and validation, reference standard lifecycle, release and stability
• Plan and execute analytical work with Process Development, Attribute Sciences, Quality, Supply Chain and Regulatory
• Oversee proposals, scope definition, work orders, performance tracking and issue escalation
• Mitigate analytical risks affecting validation readiness or product release
• Contribute to standardization, governance and external engagement models

Required profile

• Doctorate, Master's or Diploma in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences, with 2, 4 or 8 years of experience respectively in a pharma or GMP environment
• Experience in analytical development, QC or external analytical oversight in pharma or biotech
• Experience with CDMOs, CTLs or external lab networks
• Understanding of drug development lifecycle, cGMP, regulatory/CMC requirements and quality systems
• Preferred: experience with synthetic therapeutics (small molecules, peptides, oligonucleotides)
• Preferred: change management, deviation investigations and CAPA experience

Required skills

• Project management and coordination of multiple workstreams
• Strong relationship management and cross-functional teamwork
• Ability to work independently with a high degree of autonomy

Selection is subject to meeting the medical requirements of the role, and the company covers medical check costs. Apply through the Amgen careers site.