Principal Engineer

Career Category Information Systems Job Description Position Summary Amgen's Drug Substance Technologies - Synthetics (DSTS) organization within Process Development (PD) is responsible for the invention, development, and implementation of drug substance manufacturing processes and technologies that advance Amgen's portfolio of synthetic and hybrid assets. Amgen is seeking an accomplished chemical engineer and technical leader to join DSTS at Amgen India. The Principal Engineer will provide end-to-end leadership for the development, scale-up, technology transfer, commercialization, and lifecycle management of synthetic and hybrid drug substance processes. Success requires exceptional technical judgment, strong program leadership, and the ability to translate complex science into safe, robust, compliant, and manufacturable processes. The Principal Engineer will serve as Amgen's senior engineering interface for process implementation, facility and equipment fit, campaign readiness, on-the-floor support, troubleshooting, and sustained process performance. Over time, the role is expected to establish a local engineering presence, and the individual must operate at strategic and hands-on levels, lead through influence across a global matrix, and build trusted internal and external relationships. Extensive travel and regular on-site presence at the CDMO are required. Core Responsibilities ·    Lead chemical engineering deliverables for assigned synthetic and hybrid programs from early development through process characterization, technology transfer, commercialization, and lifecycle management. ·    Provides subject matter expertise across solid and liquid phase peptide synthesis to support technical package preparation, process and equipment fit assessment, scale-up strategy, facility readiness, transfer execution, engineering and validation campaign support, and post-transfer stabilization. ·    Provide decisive engineering direction at the CDMO, including on-the-floor support, rapid problem-solving, risk-based decisions, and escalation during engineering, demonstration, validation, and GMP manufacturing campaigns. ·    Build a high-trust, high-accountability technical relationship with external partners; define decision rights, priorities, risk and issue management, communication pathways, and performance expectations. ·    Lead process risk assessments, failure-mode evaluations, engineering studies, process characterization plans, control strategy development, validation preparedness, and technical contributions to regulatory filings. ·    Lead or guide investigations, root-cause assessments, deviations, non-conformances, CAPAs, change controls, and process performance reviews using data-driven and science-based recommendations. ·    Apply chemical engineering fundamentals, modeling, and manufacturing data to improve process capability, yield, purity, cycle time, safety, sustainability, productivity, and cost of goods. ·    Set priorities, identify resource needs, coordinate interdependent workstreams, manage technical risks, and communicate progress and decisions clearly to program teams and senior leaders. ·    Establish engineering standards, laboratory and modeling workflows, technical documentation expectations, digital and data practices, and decision-making frameworks. Scientific and Technical Eminence ·    Apply reaction engineering, thermodynamics, kinetics, heat and mass transfer, mixing, hydrodynamics, separations, filtration, drying, solid-liquid handling, and equipment design to development and manufacturing challenges. ·    Apply practical understanding of resin selection and handling, swelling, coupling, deprotection, washing, cleavage, precipitation, purification, isolation, drying, and related downstream operations. ·    Create fit-for-purpose laboratory and engineering experiments, representative scale-down models, and process characterization studies that define mechanisms,