Contract Development & Mfg Mgr Person in Plant

Amgen Inc. (IR); India; Remote; INR 1,800,000 - 3,000,000; Full time

Job summary

Amgen Inc. is seeking a Contract Development and Manufacturing Manager, Person-in-Plant, to serve on-site at a key manufacturing partner in India.

The role focuses on enabling operational excellence, ensuring alignment with Amgen expectations, and supporting GMP readiness and technology transfer activities. You will act as Amgen’s on-site representative, monitor daily operations, and collaborate with site personnel to resolve manufacturing issues, drive continuous improvement, and reinforce

Qualifications

• Degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 8-13 years of pharma industry experience.

Responsibilities

• Act as Amgen’s on-site representative at the external manufacturing site.
• Provide real-time visibility into plant activities, risks, and performance.
• Partner with site personnel to identify, elevate, and resolve manufacturing issues.
• Support GMP readiness and observe batch execution.
• Facilitate communication between Amgen teams and site stakeholders.
• Monitor operations and ensure alignment with timelines and quality standards.
• Drive continuous improvement with site and Amgen teams.
• Support process improvements and operational discipline.
• Provide structured feedback to program and site leads.

Skills

GMP operations

Deviations management

Change control

Technology transfer

Scale-up

Communication

Education

Degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences

Job description

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 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.

• 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, elevate, 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 is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen