Material Qualification Engineer

Location: Cambridge, MA (Hybrid, onsite Tuesday through Thursday)

The Material Qualification Engineer will provide material qualification (MQ) support for a biologics manufacturing operation in the Cambridge, MA area. This individual will develop and execute MQ strategies for single use components and QC released raw materials across commercial manufacturing processes, support patient safety programs through extractables and leachables assessments, and partner with cross-functional teams to ensure material qualification requirements are built into routine site business processes.

• Develop MQ protocols, reports, and supporting documentation for single use components and QC released raw materials used across manufacturing processes.
• Build MQ validation packages, including acquiring necessary data and summarizing results into final reports.
• Write, execute, analyze, and summarize MQ activities supporting tech transfer and new product introduction, change management, and continuous lifecycle management.
• Support the Human Daily Exposure (HDE) program, including technical assessments and extractables and leachables (E&L) calculations to ensure patient safety for commercial drug substance.
• Provide MQ technical, compliance, and quality support to tech transfer teams as required.
• Develop and assess Quality System elements for material qualification, including Quality Risk Management, CAPAs, change controls, deviations, GMP investigations, and vendor change notifications.
• Perform technical assessments of proposed changes to validated process components to identify requirements needed to maintain validated status.
• Lead development of technical strategy for MQ activities and champion site projects involving QC released chemicals and single use raw materials.
• Own MQ Quality System records as required and manage projects through closure within established timelines.

• Represent MQ in meetings and strategy discussions with operations, engineering, quality, MSAT, and new product introduction teams.
• Interface with procurement, quality, manufacturing, engineering, compliance, and process development to communicate material qualification requirements and integrate them into routine business processes.
• Partner with Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Process Development, Process Validation, Regulatory Affairs, and Facilities to execute MQ studies and projects.

• Identify and implement opportunities for continuous improvement and adoption of best practices (approximately 20%).
• Represent the site MQ function within a global MQ community of practice.
• Participate in regulatory agency inspections for material qualification (approximately 5%).

• Bachelor’s degree in Material Science, Mechanical, Biomedical, or Chemical Engineering, or a related science or engineering field, with a minimum of 4 years of relevant experience, or a Master’s degree in a related field with a minimum of 2 years of relevant experience.
• Ability to analyze data, quantify risks, and identify gaps independently.
• Ability to exercise sound judgment within defined procedures and practices to determine appropriate action.
• Ability to propose solutions to problems and elevate issues with recommended solutions to management as needed.
• Strong written communication skills for protocols, technical assessments, and reports.

• Prior experience in the pharmaceutical or biotech industry, including monoclonal antibody (mAb) manufacturing knowledge, upstream or downstream.
• Knowledge of…