Contract Development & Mfg Mgr CDMO Site Leadership

 Posted a day ago
  
 India
  
10+ years experience
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AI Summary

Provide site-level leadership and oversight for an external manufacturing partner to ensure integrated execution across development, manufacturing, and analytical activities. Act as the primary integration point between internal teams and site stakeholders to drive delivery against timelines, quality, and cost.

Career Category

Information Systems

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in innovative manufacturing capability and support services to deliver these therapies globally. Now we are hiring a Contract Development and Manufacturing Manager to support external manufacturing execution in India.

Contract Development and Manufacturing Manager CDMO Site Leadership

What you will do

The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to provide site-level leadership across a key external manufacturing partner, ensuring integrated execution across development, manufacturing, and analytical activities.

This role will serve as a central point of coordination and accountability for site performance, operating across multiple workstreams to ensure alignment, transparency, and delivery against program objectives. This role is expected to lead through influence, enabling consistent and disciplined execution across the site.

The successful candidate will operate in a highly matrixed environment, bridging internal teams and external partners to ensure delivery across timelines, quality, and cost.

  • Provide site-level leadership and oversight across all ongoing activities at the external manufacturing partner
  • Ensure aligned execution across multiple workstreams, eliminating silos and driving integrated planning and delivery
  • Act as a primary integration point between Amgen teams and site stakeholders, ensuring clear communication and escalation pathways
  • Drive execution discipline at the site, ensuring activities progress according to agreed plans and commitments
  • Identify and manage risks and dependencies, ensuring proactive mitigation and transparency
  • Partner with program, technical, and functional leads to ensure end-to-end alignment from development through manufacturing execution
  • Oversee site readiness for key milestones including GMP operations, scale-up, and commercial readiness
  • Reinforce quality and compliance expectations in alignment with cGMP and Amgen business processes
  • Enable effective execution by driving clarity of priorities, roles, and decision-making across stakeholders
  • Provide a holistic view of site performance, including timelines, risks, and deliverables, to leadership
  • Support continuous improvement efforts to enhance efficiency, transparency, and execution rigor
  • Build and maintain strong relationships with site leadership and cross-functional partners

Win

What we expect of you

Basic Qualifications

Any degree with 8-13 years of experience

Preferred Qualifications

  • Experience operating in a site-facing or site leadership role within a CDMO environment
  • Demonstrated ability to lead complex, multi-workstream execution without direct authority
  • Strong understanding of drug substance development and manufacturing through commercial
  • Experience with technology transfer, scale-up, and GMP manufacturing execution
  • Proven ability to integrate and align cross-functional teams toward common goals
  • Strong systems thinking with ability to identify interdependencies and execution gaps
  • Excellent communication, influencing, and stakeholder management skills
  • Ability to bring structure, clarity, and operational discipline to complex environments

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