Bioanalytical Program Lead (Principal Scientist) - Client Dedicated
Core
Leading the design and implementation of robust bioanalytical strategies for client-dedicated projects, ensuring lab activities align with context of use and advancing therapeutic portfolios.
Role type
Principal Scientist, Bioanalytical Program Lead
Builds
Robust bioanalytical strategies and regulatory submissions for pharmaceutical/biopharmaceutical clients
Domain
Clinical research, Bioanalysis, Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulated bioanalysis expertise (PK/CK, PD, immunogenicity), experimental design, tech transfer, regulatory agency interaction, molecular assays (ddPCR, qPCR, RT-qPCR, flow cytometry, ELISpot, viral/cytokine/ligand binding assays), Mass Spectrometry, small & large molecule bioanalysis, strategic portfolio advancement
Preferred skills
Matrix environment experience, Immunology knowledge, metabolic diseases knowledge
Technologies
ddPCR, qPCR, RT-qPCR, flow cytometry, ELISpot, Mass Spectrometry
Responsibilities
Lead design and implementation of bioanalytical strategies, aid in experimental design, interact with scientists and cross-functional groups, work with regulatory agencies and Health Authorities
Seniority
Principal, hands-on IC with strategic oversight