Contract Development & Mfg Mgr Person in Plant

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.

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

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

• 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