Engineer I, Manufacturing Science & Technology

Xeris Pharmaceuticals•Chicago, IL

3d•$70,000 - $110,000

About The Position

Overview Support process development and technical transfer of drug products in clinical development and/or post-commercialization phases. Ensure products are developed and manufactured per current regulatory requirements and industry standards (cGMP’s, QbD, ICH, etc.) by serving as a primary Point of Contact (POC) and Subject Matter Expert (SME) for external Contract Manufacturing Organizations (CMOs). Supports authorship for technical process documentation such as but not limited to Process Descriptions, QbD assessments, master batch records, technical risk assessments, etc. The Engineer I will demonstrate a basic understanding of the manufacturing unit operations (e.g. drug product formulation, sterile filtration, filling, inspection, analytics, etc.), 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.

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.
Competencies : honesty, self-driven, teamwork & collaboration, attention to detail, eagerness to learn, adaptability, professionalism, accountability

Nice To Haves

Preferred skills include project management, budgeting, etc.

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.