Overview

Support all functions of the pharmaceutical supply chain for all products throughout the product lifecycle. This includes products in process development, process optimization, and commercial phases. 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 I will demonstrate a basic understanding of the manufacturing unit operations, equipment, supply chain from drug product manufacturing through commercial packaging and how the different departments within the organization interact with each other. The Engineer I will assist with planning and execution of routine technical assignments and demonstrate a general understanding of relevant pharmaceutical regulations related to cGMP manufacturing.

Responsibilities

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

• Assists in planning development, clinical and commercial production, which includes forecasting, budgeting, and scheduling.
• Evaluate alternate 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

Qualifications

• Bachelor’s/Master’s degree required in Engineering or relevant Supply Chain, Scientific, or equivalent degree with a minimum of 3 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 computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management
• Skills preferred: Data Management, , Manufacturing/Supply Chain background, Technical Transfer/Process Validation
• Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Adaptability, Professionalism, Accountability, Project Management, Problem Solving, Communication (Written and Verbal), Organizational, Analytical, and Presentation Skills

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill obligations.
• Travel may be required at times to Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs) location. Periodic overnight travel may occur for work.
• Travel up to 15%

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

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.