Principal Engineer – Amgen

The Principal Engineer Amgen Hyderabad opening has just gone live, and it’s a rare senior-track role for a chemical engineer who wants to shape how Amgen’s synthetic and hybrid drug substance processes move from lab bench to full commercial manufacturing. Posted on July 31, 2026, under Job ID R-249067, this position sits inside Amgen’s Drug Substance Technologies – Synthetics (DSTS) group within Process Development, and it’s built for someone who can operate comfortably at both the strategic and hands-on levels of pharmaceutical engineering.

Role Overview

Amgen’s DSTS organization is responsible for inventing, developing, and implementing the manufacturing processes and technologies that support the company’s growing portfolio of synthetic and hybrid assets, including peptides and oligonucleotides. In this role, the Principal Engineer will provide end-to-end leadership across development, scale-up, technology transfer, commercialization, and lifecycle management of these processes.

This is Amgen’s senior engineering interface with contract development and manufacturing organizations (CDMOs), meaning the successful candidate will be on the floor for process implementation, facility and equipment fit assessments, campaign readiness, troubleshooting, and sustained process performance. Over time, the role is expected to help establish a local engineering presence in India, so extensive travel and regular on-site presence at the CDMO are built into the job.

1. Company: Amgen
2. Job Title: Principal Engineer
3. Job ID / Requisition: R-249067
4. Location: Hyderabad, Telangana, India
5. Work Location Type: Remote, with extensive travel and on-site CDMO presence
6. Department/Category: Process Development – Information Systems classification (DSTS function)
7. Date Posted: July 31, 2026

Core Responsibilities

The role blends program leadership with deep technical ownership. Core duties include:

1. Leading chemical engineering deliverables for synthetic and hybrid programs, from early development through process characterization, technology transfer, commercialization, and lifecycle management.
2. Serving as a subject matter expert across solid- and liquid-phase peptide synthesis, supporting technical package preparation, scale-up strategy, and transfer execution.
3. Providing decisive engineering direction at the CDMO, on-the-floor support, rapid problem-solving, and risk-based decisions during engineering, demonstration, validation, and GMP manufacturing campaigns.
4. Building high-trust technical relationships with external partners, including defining decision rights, risk management, and communication pathways.
5. Leading process risk assessments, failure-mode evaluations, process characterization plans, and control strategy development, along with technical contributions to regulatory filings.
6. Guiding investigations, root-cause assessments, deviations, CAPAs, and change controls using data-driven, science-based recommendations.
7. Applying chemical engineering fundamentals, reaction engineering, thermodynamics, kinetics, heat and mass transfer, mixing, and separations, to improve yield, purity, cycle time, safety, and cost of goods.

Also Check: Project Coordinator Pharmaceutical Life Sciences – Roche

Qualifications

Basic Qualifications

1. Degree in Chemical Engineering, with 12–17 years of relevant experience.

Preferred Qualifications

1. 8+ years of relevant experience in chemical engineering, synthetic or peptide process development, drug substance manufacturing, or technical stewardship, with evidence of increasing scope.
2. Strong knowledge of solid and/or liquid phase peptide synthesis, including direct experience with process development, scale-up, GMP transfer, and troubleshooting.
3. Demonstrated application of reaction engineering, mass transfer, mixing, separations, filtration, and process modeling at scale.
4. Fluency in interpreting analytical and process analytical data, including HPLC, LC-MS, GC, NMR, FTIR, LOD, TOC, FBRM, and particle-size analysis.
5. Track record transferring synthetic molecules, peptides, oligonucleotides, or hybrid-modality processes into internal or external GMP manufacturing sites.
6. Experience overseeing CDMOs or contract manufacturers and resolving complex technical, quality, and operational issues in regulated environments.
7. Working knowledge of cGMP expectations, process validation, data integrity, and inspection readiness.
8. Experience authoring CMC Module 3 content, regulatory technical queries (RTQs), and annual reports, along with technology-transfer packages and control strategy documents.