Role Overview
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.
Key Responsibilities
* Provide scientific leadership and SME support across LC-MS/MS studies
* Lead troubleshooting of complex analytical challenges, including matrix effects, sensitivity limitations, and assay robustness
* Advise on method development, optimisation, and validation strategies
* Support study teams in resolving technical issues and ensuring consistent assay performance
* Contribute to client interactions, including scientific discussions, data interpretation, and method justification
* Support proposals, bid defences, and scientific strategy discussions
* Mentor and support development of laboratory scientists
Technical Expertise
* Strong knowledge of LC-MS/MS theory, including triple quadrupole and HRMS systems
* Experience with sample preparation techniques such as SPE, LLE, protein precipitation, and hybrid workflows
* Deep understanding of quantitative bioanalysis, including calibration strategies, selectivity, and matrix effects
Experience with Complex Modalities
* Peptides and proteins
* Oligonucleotides
* Antibody-drug conjugates and related conjugates
Regulatory and Client Experience
* Extensive experience working under GLP and GCP
* Strong understanding of regulatory guidance (FDA, EMA, MHRA, M10)
* Experience supporting audits and regulatory inspections
* Proven ability to lead scientific discussions with clients and defend analytical approaches and data
* Ability to communicate complex technical issues clearly and challenge client assumptions where appropriate
Qualifications and Experience
* PhD in Analytical Chemistry or related field, or MSc with significant industry experience
* 10 to 15 or more years of LC-MS/MS bioanalysis experience
* Demonstrated expertise in method development, validation, and advanced troubleshooting
#J-18808-Ljbffr