Amgen

Contract Development & Mfg Mgr Person in Plant

Amgen  •  Republic of India (Remote)  •  8 hours ago
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Job Description

Career Category

Information Systems

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 on-site execution in India.

Contract Development and Manufacturing Manager, Person-in-Plant

What you will do

The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to serve as a Person-in-Plant (PiP) at a key external manufacturing partner. This role is focused on enabling operational excellence through purposeful on-site presence, ensuring alignment between Amgen expectations and day-to-day execution at the manufacturing site.

The role will partner closely with program and site leadership to drive real-time issue resolution, enhance communication, and support consistent delivery across GMP readiness, manufacturing execution, and continuous improvement initiatives.

  • Act as Amgen’s on-site representative, maintaining a consistent and purposeful presence at the external manufacturing site
  • Enable operational excellence by providing real-time visibility into plant activities, risks, and performance
  • Partner with site personnel to proactively identify, escalate, and resolve manufacturing and operational issues
  • Support GMP readiness and execution including observation of batch execution
  • Facilitate effective communication between Amgen cross-functional teams and site stakeholders
  • Monitor daily operations and ensure alignment with agreed timelines, quality standards, and program objectives
  • Drive continuous improvement initiatives in collaboration with site and Amgen teams
  • Support implementation of process improvements, best practices, and operational discipline
  • Provide structured feedback and insights to program and site leads to enhance execution
  • Support technology transfer and scale-up activities through direct engagement with plant teams
  • In partnership with Amgen External Quality, reinforce Amgen quality and compliance expectations within the site environment
  • Present observations, risks, and recommendations to internal stakeholders and leadership

Win

What we expect of you

Basic Qualifications

  • Degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 8 - 13 years of directly related pharmaceutical industry experiences

Preferred Qualifications

  • Experience operating in a Person-in-Plant or site-facing role
  • Strong understanding of GMP manufacturing operations and plant execution
  • Experience with deviation management, investigations, and change control
  • Demonstrated ability to drive operational excellence and continuous improvement
  • Experience supporting technology transfer, scale-up, or commercial manufacturing
  • Strong interpersonal skills with the ability to influence without authority in a plant environment
  • Ability to work independently and maintain effectiveness in a dynamic, on-site setting
  • Strong communication, observation, and issue-resolution skills
Amgen

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Thousand Oaks, CA
Year Founded
1980
Website
amgen.com
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