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Amgen

Contract Development & Mfg Sr Mgr

Posted 6 hours ago
10+ years experience
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AI Summary

The Senior Manager will serve as the accountable site leader for a key external manufacturing partner in India, driving integrated execution across development, manufacturing, and quality. They are responsible for managing risks, ensuring compliance with cGMP standards, and fostering high-performing cross-functional teams.

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For more than four decades, Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to patients. Amgen has not only discovered and developed innovative human therapeutics but has also invested in the manufacturing capabilities and global support services needed to deliver these therapies to patients around the world.

Amgen is seeking a Contract Development and Manufacturing Senior Manager to provide senior site leadership for external manufacturing execution in India. This role will strengthen execution discipline, cross-functional alignment, and site-level accountability across a key external manufacturing partner.

Contract Development and Manufacturing Senior Manager
CDMO Site Leadership | India

Contract Development and Manufacturing Senior Manager, CDMO Site Leadership

What you will do

The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified Senior Manager to serve as the accountable site leader for a key external manufacturing partner in India. This role is responsible for driving integrated execution across development, manufacturing, analytical, quality, supply, and site-readiness activities while ensuring alignment to program objectives, operational excellence, and external supply governance expectations.

The Senior Manager will provide leadership to both direct reports and matrix teams, strengthening connectivity between Amgen and external partner organizations while building a high-performing in-region team. Success in this role requires strong operational judgment, cross-functional leadership, and the ability to drive execution, influence decisions, manage risk, and navigate complexity across a global environment.

Key Responsibilities

  • Serve as the accountable ACDM site leader for a strategic external manufacturing partner in India.
  • Lead, coach, and develop direct reports while fostering a high-performing, engaged, and accountable team culture.
  • Drive integrated planning and execution across development, manufacturing, analytical, quality, supply chain, and readiness activities to deliver program objectives.
  • Partner with internal and external stakeholders to establish clear priorities, decision pathways, and escalation mechanisms.
  • Ensure readiness and successful execution of key milestones including technology transfer, scale-up, GMP manufacturing, validation, and commercial launch activities.
  • Monitor performance, risks, dependencies, budgets, timelines, and deliverables; provide clear recommendations and updates to senior leadership.
  • Lead issue resolution and risk mitigation efforts to protect quality, supply continuity, timeline, and financial objectives.
  • Reinforce quality, compliance, and cGMP expectations while promoting disciplined execution and continuous improvement.
  • Build and maintain effective relationships with site leadership, functional partners, and senior stakeholders across global regions.
  • Travel domestically and internationally as required to support site execution, governance, and relationship management.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The senior manufacturing and external supply leader we seek is a collaborative, accountable, and operationally disciplined professional with these qualifications:

Basic Qualifications

  • Bachelor’s degree and 12 to 17 years of Manufacturing, Operations, Process Development, External Supply, or related experience
  • 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

  • Advanced degree in chemistry or chemical engineering
  • 8+ years of pharmaceutical or biotechnology experience in manufacturing, external supply, process development, technical operations, or CDMO/CRO oversight.
  • Experience managing professional staff, including coaching, development planning, performance management, onboarding, and prioritization of work.
  • Experience operating in a site-facing or site leadership role within a CDMO or external manufacturing environment.
  • Demonstrated ability to lead complex, multi-workstream execution across global, cross-functional teams and external partners.
  • Strong understanding of drug substance development and manufacturing from development through commercial readiness; peptide or small molecule experience preferred.
  • Experience with technology transfer, scale-up, GMP manufacturing execution, validation readiness, and commercial site readiness.
  • Strong knowledge of cGMPs, quality systems, regulatory/CMC expectations, and pharmaceutical operations.
  • Proven ability to integrate technical, analytical, quality, supply chain, sourcing, and external partner inputs into executable plans.
  • Strong project management, operational discipline, systems thinking, and ability to identify interdependencies, gaps, and risks.
  • Demonstrated ability to influence stakeholders, manage escalation pathways, and communicate clearly across cultures, functions, and time zones.
  • Experience managing budgets, purchase orders, supplier performance, scopes of work, or external manufacturing financials preferred.
  • Self-starter who thrives in fast-paced, ambiguous, and complex environments while consistently delivering quality outcomes.
  • Demonstrated commitment to teamwork, accountability, innovation, inclusion, talent development, and patient focus.

Thrive

What you can expect of us

  • Vast opportunities to learn and grow across a global organization.
  • Inclusive environment that values diverse perspectives and empowers teammates to contribute ideas.
  • Comprehensive benefits supporting health, finance, and work-life balance.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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