Contract Development & Mfg Mgr

Amgen Technology; Hyderabad; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Amgen announces an opportunity for Contract Development and Manufacturing Manager to lead external peptide manufacturing programs across development, clinical, and commercial stages. The role interfaces with CDMOs and site leads to ensure alignment on priorities, tolerances, and deliverables within a highly matrixed, global setting.

The successful candidate will drive technology transfer, scale-up, and process readiness in collaboration with Process Development and site teams, ensuring GMP

Qualifications

• Experience leading external manufacturing programs at CDMOs, preferably peptides.
• Knowledge of technology transfer and scale-up within GMP environments.
• Ability to operate in a global, matrixed organization with shared accountabilities.

Responsibilities

• Lead external peptide manufacturing programs end-to-end across development, clinical, and commercial stages.
• Interface with CDMOs and site leads to align program priorities and deliverables.
• Drive tech transfer, scale-up, and process readiness with Process Development and site teams.
• Oversee manufacturing activities to ensure GMP readiness.
• Identify and mitigate technical, supply, and regulatory risks.
• Collaborate across Process Development, Analytical, Quality, Supply Chain, Regulatory.
• Support sourcing and externalization activities including SoW and supplier engagement.
• Ensure adherence to cGMP and Amgen processes including deviations, change control, investigations.
• Monitor program performance across timeline, quality, cost; escalate issues.
• Present updates and recommendations to senior management.
• Occasional domestic and international travel.

Skills

Program leadership

CDMO collaboration

GMP readiness

Cross-functional teamwork

Risk management

Education

Bachelor's degree

Job description

Contract Development and Manufacturing Manager - The Amgen Contract Development and Manufacturing (ACDM) Organization seeks a highly qualified candidate to work with external development and manufacturing partners to ensure uninterrupted clinical and commercial supply for the portfolio. The position will be in the TIDES business unit of ACDM and will focus on late-phase clinical and commercial peptide manufacturing. This role is cross-functional and global, supporting external process development, supplier relationship management, and oversight of manufacturing activities. The successful candidate will operate in a highly matrixed environment, driving cross-functional alignment and ensuring delivery across timelines, quality, and cost.

Responsibilities

• Serve as program lead for external peptide manufacturing, accountable for end-to-end execution across development, clinical, and commercial stages
• Act as a primary interface with CDMOs, working alongside the site lead to ensure alignment on program priorities and deliverables
• Drive technology transfer, scale-up, and process readiness in collaboration with Process Development and site teams
• Provide oversight of manufacturing activities to ensure readiness for GMP operations
• Identify and manage program risks (technical, supply, regulatory) and drive mitigation strategies
• Partner cross-functionally (Process Development, Analytical, Quality, Supply Chain, Regulatory) to ensure integrated execution
• Support sourcing and externalization activities including Scope of Work (SoW) development and supplier engagement
• Ensure adherence to cGMP requirements and Amgen business processes including deviations, change control, and investigations
• Monitor and manage program performance across timeline, quality, and cost, escalating issues as needed
• Present program updates, risks, and recommendations to senior management
• Occasional domestic and international travel

What we expect of you

Basic Qualifications

Any degree with 8-13 years of experience

Preferred Qualifications

• Experience leading external manufacturing programs at CDMOs, preferably in peptides or related modalities
• Demonstrated experience in technology transfer, scale-up, and GMP readiness
• Strong understanding of drug substance development through commercial manufacturing
• Experience working closely with manufacturing sites in a site-facing role
• Ability to operate effectively in a matrixed, global organization with shared accountabilities
• Strong project leadership, stakeholder management, and communication skills
• Ability to proactively identify and resolve complex technical and operational risks