Manufacturing Manager Biologics MSAT

Parenterals Manufacturing Manager Biologics Drug Product - 6 months contractOur customer is a major player in the biopharmaceutical industry, offering a wide range of globally established and recognized products. A whole part of the value-added chain, from R&D processes up to final product launch, is led in Switzerland. The new position of a Manager for Sterile Drug Product requires significant experience in manufacturing, compounding and filling of sterile drug products in vials, pre-filled syringes and expertise:- Manage manufacturing or complaint on product impact, including root cause analysis, CAPA and impact assessment- Support the process capability analysis and Continuous Process of key quality and different CMOs- Provide Impact assessments of change requests- Support of review of technical documents and activitiesYou will be Subject expert (SME) in sterile manufacturing processes, with a strong knowledge of global requirements (FDA) to the design and control of these processes. You have the technical knowledge of sterile manufacturing technology and processing abilities:- Experienced as GMP and complaint in the relevant SOPs, cGMPs and GLPs guidelines and- Experienced to work and manage within a to work within and lead cross-functional technical teams, across multiple cultures- Knowledgeable in some, including use of software identify and execute process robustness improvement projects, where required. Using this and knowledge to contribute to comprehensive and annual product reviews, as well as performance assessment of CMOs. You will support change management, CAPA and contractorskill profile:- scientific or engineering degree- 3- 5y experience in commercial manufacturing of sterile drug products- Experience in parenteral compounding and filling- Involvement in CAPA s and risk assessmets (FMEA)- Understanding of process, engineering, analytical and aspects of sterile drug product manufacturingYour solution-oriented approach allows you to and in an effective way. Your English is fluent. The position requires occasional level of travel. jid97c5a6faen jit0833aen jpiy26aen