Bioanalytical Program Lead (Principal Scientist)

Bioanalytical Program Lead (Principal Scientist)
Thermo Fisher Scientific
Remote
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
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Thermo Fisher Scientific