Stellenbeschreibungph3Principal Scientist, Pathogen Safety Support /h3 h3The Opportunity /h3 pThe Principal Scientist, Pathogen Safety Support provides scientific and operational expertise to support pathogen safety activities across manufacturing, technical operations, and product lifecycle management. /p pThis role partners closely with cross‑functional stakeholders to assess pathogen safety risks, support regulatory and compliance obligations, and contribute to projects that ensure the continued safety, quality, and supply of CSL products. /p pThe successful candidate will serve as a trusted scientific expert, delivering pathogen safety assessments, technical guidance, and operational support while driving continuous improvement and compliance excellence across the organization. /p h3Responsibilities /h3 h3Scientific Support Delivery /h3 ul liPlan and execute scientific work packages supporting pathogen safety activities across the product lifecycle. /li liConduct scientific risk assessments related to manufacturing changes, deviations, product complaints, pharmacovigilance investigations, and other operational matters. /li liAuthor and review technical documents, annual reports, regulatory submissions, and responses to health authority requests. /li liSupport internal and external inspections, audits, and regulatory commitments. /li liProvide scientific and technical support to pathogen safety projects and cross‑functional initiatives. /li liResolve technical and operational issues impacting pathogen safety deliverables and project timelines. /li /ul h3Cross‑Functional Collaboration /h3 ul liCollaborate with Manufacturing Sciences Technology (MST), Technical Operations, Quality, Regulatory Affairs, and other stakeholders to assess and prioritize pathogen safety requests. /li liParticipate in cross‑functional planning and resource discussions within the Pathogen Safety organization. /li liSupport projects governed through Technical Operations and other business functions. /li liBuild effective partnerships across global, multicultural, and matrixed teams. /li /ul h3Continuous Improvement /h3 ul liIdentify and implement opportunities to improve workflows, processes, and knowledge‑sharing practices. /li liChampion best practices, operational excellence initiatives, and digital solutions that enhance efficiency and scientific effectiveness. /li /ul h3Training Knowledge Transfer /h3 ul liDeliver training and scientific guidance to Operations and Technical staff on pathogen safety topics. /li liSupport the development and maintenance of pathogen safety knowledge within the organization. /li /ul h3Compliance Quality /h3 ul liEnsure all scientific activities are performed in accordance with applicable regulations, quality standards, and internal procedures. /li liPromote a strong culture of quality, compliance, and scientific rigor. /li /ul h3Qualifications /h3 h3Education /h3 ul liBachelor's degree in Virology, Microbiology, Biotechnology, Biology, Chemistry, or a related scientific discipline. /li liAdvanced degree (MSc or PhD) in a relevant field strongly preferred. /li /ul h3Experience /h3 ul liMinimum 5 years of experience within the biopharmaceutical, biotechnology, or life sciences industry. /li liDemonstrated experience supporting drug development, commercial manufacturing, or technical operations environments. /li liProven ability to contribute technical expertise within cross‑functional pharmaceutical projects. /li liExperience working in global, multicultural, and matrixed organizations. /li /ul h3Knowledge Skills /h3 ul liStrong scientific expertise in pathogen safety and related disciplines. /li liExcellent analytical, problem‑solving, and risk assessment capabilities. /li liStrong stakeholder management and collaboration skills with the ability to influence without direct authority. /li liExcellent written and verbal communication skills. /li liAbility to manage multiple priorities and deliver results in a fast‑paced environment. /li /ul h3Working Conditions /h3 ul liOperates within a dynamic, matrixed organization requiring flexibility, prioritization, and effective collaboration across multiple functions. /li liAbility to navigate ambiguity and competing priorities while maintaining high‑quality scientific output. /li /ul h3Travel /h3 ul liOccasional domestic and international travel may be required to manufacturing and development sites. /li /ul /p #J-18808-Ljbffr
