Engineer I, Commercial Manufacturing
Xeris Pharmaceuticals, Inc.Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Engineer I, Commercial Manufacturing — Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP’s and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing.
Responsibilities
- Assist in commercial production planning
- Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply
- Help with logistics activities such as quotes, invoices, inventory management and shipment of products and intermediates
- Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities
- Accurately collects / performs data mining and appropriately records / trends observations
- Aid 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 Device Development, Quality Assurance, Quality Control, Regulatory, and Finance
Qualifications
- Bachelor’s degree required, master’s degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals
- Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with 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
- Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
- Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris’ Chicago office. A minimum of four days per week on site is required. On site requirement may change at management’s discretion.
Additional Requirements
- The level of the position will be determined based on the selected candidate’s qualifications and experience.
- 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.