Engineer I, Manufacturing Science & Technology

Xeris Pharmaceuticals, Inc. is focused on drug products in clinical development and commercialization. The Engineer I will support process development and technical transfer, ensuring compliance with regulatory requirements while serving as a primary point of contact for external manufacturing organizations.

Responsibilities:

• Serves as the Subject Matter Expert (SME) for drug product manufacturing process development and technical transfer – internally and externally
• Serves as the primary POC for CMO relationships
• Provides on-site support at CMOs during critical manufacturing activities
• Supports authorship for technical process documentation such as but not limited to Process Descriptions, QbD assessments, technical risk assessments, etc. – internally and/or externally
• Reviews and provides technical input for GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations – internally and/or externally
• Supports routine, day-to-day manufacturing activities to ensure product meets quality and business requirements
• Evaluates manufacturing technologies, equipment, and processes for continuous improvements throughout product development and product lifecycle management
• Works cross-functionally to support forecasting, scheduling, and budgeting of process development and/or technical transfer activities
• Works cross-functionally to manage logistical activities such as quotes, purchase orders, invoices, inventory management and shipment of product
• Accurately collects / performs data mining and appropriately records / trends observations
• Collaborate with other functions such as CMC, Formulation Development, Analytical Development, Device Development, Quality Assurance, Quality Control, Regulatory, Project Management, and Finance

Requirements:

• Bachelor's/Master's degree required in Engineering or relevant Scientific discipline, or equivalent degree with a minimum of 3 years of experience working in pharmaceuticals
• Minimum of 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with knowledge of aseptic processing and sterile drug product manufacturing
• Must have strong technical writing, critical thinking, problem solving, analytical, communication (verbal and written), and computer (including all Microsoft Office) skills
• Must have experience leading or supporting process development, process validation and/or technical transfer
• Must be able to work cross-functionally across internal and external organizations
• Preferred skills include project management, budgeting, etc