Principal Engineer

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, operating ranges, robustness, and scale-up criteria.

·Apply first-principles models, process simulation, statistical analysis, design of experiments, multivariate methods, data visualization, process monitoring, and process analytical technologies to solve problems and predict performance.

·Integrate process safety, equipment and facility fit, material compatibility, containment, operability, maintainability, and human-factor considerations into process and technology-transfer decisions.

·Author, review, and defend engineering reports, technology-transfer packages, risk assessments, control strategy documents, validation content, technical investigations, and regulatory filing sections.

·Maintain current knowledge of SPPS, peptide and synthetic drug substance manufacturing, automation, modeling, process analytical technologies, and industry practices; bring relevant innovations into Amgen programs.

Teamwork and Leadership Attributes

·Lead Process Engineering and drug substance development teams facilitating cohesiveness and team spirit as we work toward a common goal to develop industry

·Translate strategy into clear objectives, establish priorities, allocate resources, delegate effectively, hold teams accountable, and deliver results across multiple complex and time-sensitive workstreams.

·Shape technical and business decisions through scientific depth, sound engineering judgment, constructive challenge, data-driven recommendations, and the ability to align stakeholders without relying on formal authority.

·Establish trusted relationships with CDMO leaders and technical teams while maintaining clear accountability, protecting Amgen requirements, and addressing conflict or performance gaps directly and professionally.

·Distill complex technical information into concise recommendations, decision points, risks, and trade-offs for senior leaders, governance forums, regulatory stakeholders, and external partners.

·Anticipate issues, make timely decisions with incomplete information, adapt plans as evidence evolves, and maintain focus on the highest-value patient and business outcomes.

·Promote scientific excellence, engineering rigor, safety, quality, compliance, collaboration, inclusion, ownership, and a patient-focused, high-performance culture.

Basic Qualifications

·Degree in Chemical Engineering and 12-17 years of relevant experience

Preferred Qualifications

·8+ years of relevant experience in chemical engineering, synthetic or peptide process development, pharmaceutical drug substance manufacturing, technology transfer, or technical stewardship, with evidence of increasing scope and accountability.

·Strong knowledge of solid and/or liquid phase peptide synthesis, including direct experience with process development, scale-up, GMP transfer, manufacturing support, and troubleshooting.

·Demonstrated application of reaction engineering, mass transfer, mixing, separations, filtration, drying, hydrodynamics, solids handling, process modeling, statistical methods, and scale-up.

·Fluency in lab-based execution and data interpretation of wide variety of analytical methods, process analytical tools, and solid-state characterization including, with working knowledge of relevant methods such as HPLC, LC-MS, GC, NMR, FTIR, LOD, TOC, FBRM, and particle-size analysis.

·Successful transfer of synthetic molecules, peptides, oligonucleotides, or hybrid-modality processes to internal or external GMP manufacturing sites, including facility and equipment fit assessments and campaign readiness.

·Experience providing technical oversight of CDMOs, external manufacturers, or contract producers and resolving complex technical, quality, operational, and relationship issues in regulated environments.

·Knowledge of cGMP expectations, process validation, data integrity, quality systems, regulatory requirements, change management, inspection readiness, and maintenance of processes in a qualified or validated state.

·Demonstrated success leading investigations, root-cause analysis, risk assessments, process characterization, control strategy development, and science-based resolution of manufacturing deviations and performance trends.

·Experience using first-principles modeling, process simulation, design of experiments, statistical analysis, data visualization, process monitoring, automation, or process analytical technologies to accelerate decisions and improve robustness.

·Experience authoring regulatory documents for commercialization of drug substance process: CMC Module 3, RTQs and annual reports

·Experience authoring or reviewing technology-transfer packages, engineering reports, process characterization plans, validation documents, technical investigations, control strategies, and regulatory filing content.

·Ability to connect technical details to portfolio, supply, quality, cost, and patient impact; communicate complex topics to senior leaders; and influence decisions across a global, matrixed organization.

·Ability to manage multiple priorities, work effectively across cultures and time zones, maintain strong external-partner presence, and travel extensively to the CDMO site while upholding Amgen standards for safety, quality, compliance, collaboration, and service to patients.