ul liEnsure timely plant readiness to support experimental and clinical activities. /li liEnsure timely delivery of clinical material from internal pilot plants or external contract manufacturing organizations (CMOs). /li liManage the overall relationship with internal and external manufacturers, acting as the single point of contact between the organization and each manufacturing site. /li liProvide pilot plant input and requirements to Drug Product Development (DPD) and Primary Container Development (PCD). /li liSupport scale-up and technology transfer activities. /li liSource raw materials and components as required, and act as the point of contact for material- and supplier-related issues at the CMO. /li liPut in place the relevant manufacturing information and technical capabilities to enable the operations team to produce the drug product (DP) flawlessly, in line with GxP, EHS and business requirements. /li liEnsure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations. /li liSupport investigations, CAPAs and change controls according to assigned responsibilities, and perform critical raw data review of key documents. /li liAssess new technologies and applications, covering feasibility, business case, conceptual design, installation and implementation. /li /ul h3Profile: /h3 ul liDegree in Pharmaceutical, Biochemical, Life, Chemical or other relevant Sciences, or comparable experience, with a demonstrated track record of 7+ years in the pharmaceutical industry or a related field; alternatively, a PhD with 3+ years of proven experience. /li liDemonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is an asset. /li liDemonstrated proficiency and experience in biopharmaceutical process design is an asset. /li liSolid understanding of, and experience in, technology transfer operations is preferred. /li liSolid understanding of, and experience in, fill/finish operations is preferred. /liliExperience in clinical or commercial manufacturing is required; prior experience working with a CMO is preferred. /li liProven track record of creativity and problem-solving. /li liAbility to collaborate with cross-functional teams is a must. /li liExcellent oral and written English skills; German is a plus. /li /ul #J-18808-Ljbffr
Senior Lead, MST & External Manufacturing
