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Principal Scientist I – LC-MS/MS

synexalifesciences

MacclesfieldOn-site2mo ago
Employment
Full-time
Seniority
Staff

About the role

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

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