31 Jul
|
Amgen
|
Telangana
HOW MIGHT YOU DEFY IMAGINATIONContract Development and Manufacturing Manager, Person-in-PlantWhat 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 Amgens 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
WinWhat we expect of youBasic 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
- Robust 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
📌 Contract Development & Mfg Mgr Person in Plant (Telangana)
🏢 Amgen
📍 Telangana