Engineer I, Manufacturing Science & Technology

Job description

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. Responsibilities: Support manufacturing operations at Contract site...