Bioanalytical Program Lead – Principal Scientist

🕒 5 days ago

🌐 United Kingdom, Sweden – Remote

🇬🇧 United Kingdom – Remote 🇸🇪 Sweden – Remote

⏰ Full Time

🟠 Senior

🧬 Research Scientist

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead the design and implementation of robust bioanalytical strategies • Ensure laboratory-based activities are aligned with context of use • Work in a matrix environment, managing experimental design and technology transfer • Interact closely with primarily lab-based scientists • Aid in experimental design where required • Apply scientific knowledge and expertise across collaborators and cross-functional groups • Work with regulatory agencies and Health Authorities across countries and geographies • Mitigate regulatory risk • Submit regulatory documents and respond to Health Authority questions • Work as part of the customer’s global biopharma team in a client-dedicated role

🎯 Requirements

• BSc in a relevant subject with 10+ years of experience in Bioanalysis • Proven experience as a Subject Matter Expert in regulated bioanalysis across PK/CK, PD, and immunogenicity assessments (humoral and cellular) • Experience as a bioanalytical lead in diverse project teams, defining, leading, and implementing bioanalytical strategies • Experience developing Biomarker and Target Engagement strategies for dose-decision endpoints • Expertise in molecular assays including ddPCR, qPCR, and RT-qPCR • Expertise in flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays, and mass spectrometry • Deep understanding of small- and large-molecule bioanalysis • Experience in regulated bioanalysis for multiple drug modalities • Proven publication and presentation record • Exceptional verbal and written communication skills • Fluency in English is essential

🏖️ Benefits

• Full-time benefits • Remote/home-based work arrangement

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