Contract Development & Mfg Mgr Person in Plant

Biopharma Careers; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amgen is seeking a Contract Development and Manufacturing Manager, Person-in-Plant, to be the on-site representative at a key external manufacturing partner in India. The role focuses on enabling operational excellence, real-time risk visibility, and alignment with Amgen expectations.

You will work with program and site leadership to drive issue resolution, GMP readiness, and continuous improvement initiatives while supporting technology transfer and scale-up activities within a compliant

Qualifications

• Degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences.

Responsibilities

• Act as Amgen’s on-site representative at the external manufacturing site.
• Enable real-time visibility into plant activities, risks, and performance.
• Collaborate with site personnel to identify, escalate, and resolve manufacturing issues.
• Support GMP readiness and execution including observation of batch execution.
• Facilitate communication between Amgen teams and site stakeholders.
• Monitor operations to ensure timelines, quality, and program objectives.
• Drive continuous improvement with site and Amgen teams.
• Support implementation of process improvements and best practices.
• Provide feedback to program and site leads to enhance execution.
• Support technology transfer and scale-up activities with plant teams.
• Reinforce Amgen quality and compliance expectations within the site.

Skills

GMP knowledge

Deviation management

Investigations

Change control

Technology transfer

Scale-up

Operational excellence

Cross-functional collaboration

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.

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, escalat, 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