Principal Scientist - LC-MS/MS Bioanalysis (PK/PD, Complex Modalities)

Role Overview <p>We are seeking a Principal Scientist - LC-MS/MS Bioanalysis (PK/PD, Complex Modalities) to act as a subject matter expert across LC-MS/MS bioanalytical programmes supporting PK and PD studies. This role provides scientific leadership across multiple studies, focusing on complex problem-solving, assay strategy, and client engagement.</p> Key Responsibilities <ul><li>Provide scientific leadership and SME support across LC-MS/MS studies</li><li>Lead troubleshooting of complex analytical challenges, including matrix effects, sensitivity limitations, and assay robustness</li><li>Advise on method development, optimisation, and validation strategies</li><li>Support study teams in resolving technical issues and ensuring consistent assay performance</li><li>Contribute to client interactions, including scientific discussions, data interpretation, and method justification</li><li>Support proposals, bid defences, and scientific strategy discussions</li><li>Mentor and support development of laboratory scientists</li></ul> Technical Expertise <ul><li>Strong knowledge of LC-MS/MS theory, including triple quadrupole and HRMS systems</li><li>Experience with sample preparation techniques such as SPE, LLE, protein precipitation, and hybrid workflows</li><li>Deep understanding of quantitative bioanalysis, including calibration strategies, selectivity, and matrix effects</li></ul> Experience with Complex Modalities <ul><li>Peptides and proteins</li><li>Oligonucleotides</li><li>Antibody-drug conjugates and related conjugates</li></ul> Regulatory and Client Experience <ul><li>Extensive experience working under GLP and GCP</li><li>Strong understanding of regulatory guidance (FDA, EMA, MHRA, M10)</li><li>Experience supporting audits and regulatory inspections</li><li>Proven ability to lead scientific discussions with clients and defend analytical approaches and data</li><li>Ability to communicate complex technical issues clearly and challenge client assumptions where appropriate</li></ul> Qualifications and Experience <ul><li>PhD in Analytical Chemistry or related field, or MSc with significant industry experience</li><li>10 to 15 or more years of LC-MS/MS bioanalysis experience</li><li>Demonstrated expertise in method development, validation, and advanced troubleshooting</li></ul><img src="https://www.jobg8.com/Tracking.aspx?%2bjBHvVsVsDcxqflaja0j8CXtkLjs904dv" width="0" height="0" />