Engineer II, Manufacturing Science & Technology

The Engineer II, Manufacturing Science & Technology position is responsible for all aspects of process development, scaleup, technology transfer, and commercialization for Xeris’s pipeline programs and will also provide technical support as needed for Xeris’ commercial products.  This includes responsibilities for internally developed drug substances (APIs), intermediates, and drug products (formulations) as well as development-stage and commercial-stage programs that may be in-licensed or acquired. Ensure products are developed and manufactured per current regulatory requirements and industry standards (cGMP’s, QbD, ICH, etc.). Ensure raw materials and components are available and product is manufactured within established development, clinical or commercial timelines. Work cross-functionally with other teams to ensure commercial product is available for sale per commercial forecasts. The Engineer II will demonstrate a broad understanding of manufacturing unit operations, equipment, supply chain from drug product manufacturing through packaging and distribution and how the different departments within the PDTO organization interact with each other. The Engineer II will assist with planning and execution of routine technical assignments and demonstrate a firm understanding of relevant pharmaceutical regulations related to cGMPs.

Support manufacturing operations at Contract sites (CMOs, etc.).  Responsibilities include, but may not be limited to:

• Assists in planning development studies and clinical supplies manufacturing, which includes forecasting, budgeting, and scheduling.
• Interface and collaborate with the product development group for knowledge and technology transfer of products to manufacturing sites.
• Evaluate alternative technologies and equipment for manufacturing process improvement.
• Supports colleagues in routine, day-to-day manufacturing activities to ensure product is manufactured on time within development, clinical or commercial timelines.
• Provides on-site support at Contract sites (CMOs, etc.) during critical manufacturing activities.
• Helps with logistics activities such as quotes, purchase orders, invoices, inventory management and shipment of product.
• Frequently interacts with other functional peer group managers and CMOs to support development, clinical or commercial manufacturing activities.
• Accurately collects / performs data mining and appropriately records / trends observations.
• Writing technical protocols and reports for process engineering studies.
• Aids in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations.
• Collaborate with other functions such as Product Development, Device Development, Quality Assurance, Quality Control, Regulatory and Finance.

• Bachelor’s/Master’s degree required in Engineering or relevant Supply Chain, Scientific, or equivalent degree with minimum 5 years of experience working in a pharmaceutical industry.
• Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with knowledge of aseptic processing and sterile drug product manufacturing.
• Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management.
• Skills preferred: Data Management, Project Management, Manufacturing/Supply Chain background, Technical Transfer/Process Validation, Problem Solving, Communication (written and verbal), Organizational, Analytical, and Presentation skills.
• Competencies:  Teamwork & Collaboration, Attention to Detail, Self-Starter, Adaptability, Professionalism, Accountability.
• Working Conditions: Domestic and international travel (up to 25%) required. May require periodic evening and/or weekend activity to meet company deadlines and/or satisfy peak project workloads. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

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