Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Bioanalytical Program Lead – client dedicated Location: UK or Sweden (remote/home based) Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Role Summary This is a client dedicated role where you will be working as part of our customer’s global biopharma team. As a Bioanalytical Program Lead you will be leading the design and implementation of robust bioanalytical strategies. This role is pivotal in ensuring lab-based activities are aligned with context of use. You will be working in a matrix environment, managing aspects such as experimental design and tech transfer. This role requires close interaction with other scientific and technical staff in the lab. If you have a strong track record in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas, this could be the perfect opportunity for you! Responsibilities: You will interact closely with scientists who are primarily lab based, and you will be required to aid in experimental design where required. This is a highly visible role, and you will be required to use your scientific knowledge and expertise while working with a range of collaborators and cross functional groups. You will also work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions. Essential Skills/Experience: BSc in relevant subject with 10+ yrs experience in Bioanalysis required Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (humoral and cellular) Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio including Biomarker & Target Engagement strategy for dose decision endpoints. Skilled scientist able to discern the advantages and pitfalls of a range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry. Deep understanding of small & large molecule Bioanalysis Experienced in regulated bioanalysis for multiple drug modalities. Proven publication and presentation record Exceptional verbal and written communication skills, with fluency in English essential Desirable Skills/Experience: Experience of working in a matrix environment Knowledge of Immunology and or metabolic diseases Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Apply today to help us deliver tomorrow’s breakthrough