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Principal scientist, pathogen safety

Bern
CSL Plasma Inc.
Inserat online seit: 10 Juni
Beschreibung

Ph3Principal Scientist, Pathogen Safety Support /h3h3Overview /h3pThe Principal Scientist, Pathogen Safety Support provides scientific and operational expertise to support pathogen safety activities across manufacturing, technical operations, and product lifecycle management. This 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. /ph3Responsibilities /h3ulliPlan and execute scientific work packages supporting pathogen safety activities across the product lifecycle. /liliConduct scientific risk assessments related to manufacturing changes, deviations, product complaints, pharmacovigilance investigations, and other operational matters. /liliAuthor and review technical documents, annual reports, regulatory submissions, and responses to health authority requests. /liliSupport internal and external inspections, audits, and regulatory commitments. /liliProvide scientific and technical support to pathogen safety projects and cross‑functional initiatives. /liliResolve technical and operational issues impacting pathogen safety deliverables and project timelines. /li /ulh3Cross‑Functional Collaboration /h3ulliCollaborate with Manufacturing Sciences Technology, Technical Operations, Quality, Regulatory Affairs, and other stakeholders to assess and prioritize pathogen safety requests. /liliParticipate in cross‑functional planning and resource discussions within the Pathogen Safety organization. /liliSupport projects governed through Technical Operations and other business functions. /liliBuild effective partnerships across global, multicultural, and matrixed teams. /li /ulh3Continuous Improvement /h3ulliIdentify and implement opportunities to improve workflows, processes, and knowledge‑sharing practices. /liliChampion best practices, operational excellence initiatives, and digital solutions that enhance efficiency and scientific effectiveness. /li /ulh3Training Knowledge Transfer /h3ulliDeliver training and scientific guidance to Operations and Technical staff on pathogen safety topics. /liliSupport the development and maintenance of pathogen safety knowledge within the organization. /li /ulh3Compliance Quality /h3ulliEnsure all scientific activities are performed in accordance with applicable regulations, quality standards, and internal procedures. /liliPromote a strong culture of quality, compliance, and scientific rigor. /li /ulh3Working Conditions /h3pThe role operates within a dynamic matrixed organization requiring flexibility, prioritization, and effective collaboration across multiple functions. The individual must navigate ambiguity and competing priorities while maintaining high‑quality scientific output. /ph3Travel /h3pOccasional domestic and international travel may be required to manufacturing and development sites. /ph3Qualifications /h3ulliEducation: Bachelor’s degree in Virology, Microbiology, Biotechnology, Biology, Chemistry, or a related scientific discipline. /liliAdvanced degree (MSc or PhD) in a relevant field strongly preferred. /liliMinimum 5 years of experience within the biopharmaceutical, biotechnology, or life sciences industry. /liliDemonstrated experience supporting drug development, commercial manufacturing, or technical operations environments. /liliProven ability to contribute technical expertise within cross‑functional pharmaceutical projects. /liliExperience working in global, multicultural, and matrixed organizations. /liliStrong scientific expertise in pathogen safety and related disciplines. /liliExcellent analytical, problem‑solving, and risk assessment capabilities. /liliStrong stakeholder management and collaboration skills with the ability to influence without direct authority. /liliExcellent written and verbal communication skills. /liliAbility to manage multiple priorities and deliver results in a fast‑paced environment. /li /ulh3Equal Opportunity Employer /h3pCSL is an Equal Opportunity Employer. Individuals with a disability who require reasonable accommodation for any part of the application process may request assistance. /p /p #J-18808-Ljbffr

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