Parenterals Manufacturing Manager Biologics MSAT

h2Biologics Drug Product – 6 months contract /h2 pOur 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 scale up of RD processes up to final product launch, is led in Switzerland. The new position of a Manager for strongSterile Drug Product /strong requires significant experience in manufacturing, compounding and filling of strongsterile drug products in vials, pre-filled syringes and cartridges. /strongbrstrongYour expertise: /strong /p ul liManage manufacturing or complaint investigations on product impact, including root cause analysis, CAPA generation, and impact assessment /li liSupport the process capability analysis and Continuous Process Verification of key quality attributes and parameters at the strongdifferent CMOs /strong /li liProvide Impact assessments of change requests /li liSupport of review of technical documents and data verification activities /li /ul pYou will be Subject matter expert (SME) in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes. You have the technical knowledge of strongsterile manufacturing technology /strong and processing techniques. /p pstrongYour abilities: /strong /p ul liExperienced as deviation investigator, GMP change management and complaint investigations. /li liExperienced in the relevant SOPs, cGMPs and GLPs guidelines and /li liExperienced to work and manage within a regulatory environment. /li liAble to work within and lead cross-functional technical teams, across multiple cultures /li liKnowledgeable in some statistical analysis capability, including use of statistical software platforms /li /ul pYou identify and execute strongprocess robustness improvement projects /strong, where required. Using this information and knowledge to contribute to comprehensive and accurate annual product reviews, as well as performance assessment of CMOs. You will support strongchange management, investigation CAPA identification /strong and related activities at the contractor sites. /p pYour skill profile: /p ul liscientific or engineering degree /li li3- 5y experience in commercial manufacturing of sterile drug products /li listrongExperience in parenteral compounding and filling /strong /li liInvolvement in deviations, CAPA’s and risk assessmets (FMEA) /li liUnderstanding of process, engineering, analytical and regulatory aspects of sterile drug product manufacturing /li /ul pYour solution-oriented approach allows you to communicate and negotiate in an effective way. Your English is fluent. The position requires occasional level of travel. /pbrpgloorlang THE RIGHT CHOICE IN CONSULTATION FOR LIFE SCIENCE TALENTS /p