Principal Engineer (Chemical Engineering)

Overview

Principal Engineer (Chemical Engineering) in Amgen's Drug Substance Technologies - Synthetics (DSTS) organization within Process Development, leading development, scale-up, technology transfer, commercialization, and lifecycle management of synthetic and hybrid drug substance processes at Amgen India.

What you'll do

• Lead chemical engineering deliverables for assigned synthetic and hybrid programs from early development through process characterization, technology transfer, commercialization, and lifecycle management.
• Provide 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.
• 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.
• 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.

What you'll need

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

Nice to have

• 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.

Details

• Location: India - Hyderabad.
• Extensive travel and regular on-site presence at the CDMO are required.