Lead Bioanalytical Scientist – LBA & GxP Oversight

Synexa Life Sciences

Macclesfield

On-site

GBP 60,000 - 90,000

Full time

4 days ago
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Job summary

Synexa Life Sciences is seeking an experienced Senior Scientist II (LBA) to lead bioanalytical and Ligand Binding Assay studies in a regulated CRO environment. You will act as RS/SD/PI, overseeing assay development, validation, transfer, and sample analysis to ensure GxP compliance.

You will manage study teams, plan resources, troubleshoot assays, mentor staff, review documents, and support client communications.

Qualifications

  • Master's degree in a natural science or 5+ relevant experience.
  • Strong knowledge of analytical techniques (e.g., LC/MS, flow cytometry, immunoassays etc.) and GxP principles (GLP, GCP, GMP, GCLP).
  • Proficient with advanced instruments (e.g., Mass Spectrometry, MSD, Epoch, flow cytometers, PCR systems).
  • Proficient in following protocols, and using standard equipment (centrifuges, biosafety cabinets, incubators).
  • Good command of written and spoken English, with strong collaboration and negotiation skills.

Responsibilities

  • Lead study-specific laboratory staff and ensure GxP compliance.
  • Develop, validate, and apply bioanalytical assays for studies for RS/SD/PI roles.
  • Manage study planning, reagent and capacity requirements.
  • Review project documents and ensure high-quality reporting.
  • Lead studies and manage change orders and protocols.
  • Support revenue generation and project quotes.
  • Maintain ERP timesheets and provide staff training.
  • Stay updated on bioanalysis trends and EMA/FDA guidelines.
  • Author and maintain SOPs and training materials.

Skills

GxP principles
Bioanalysis methods
Staff leadership
Client communication

Education

Master's degree in natural science

Tools

Mass Spectrometry
Flow Cytometry
PCR Systems
Epoch instrument

Job description

Synexa Life Sciences is seeking an experienced Senior Scientist II (LBA) to lead bioanalytical and Ligand Binding Assay studies in a regulated CRO environment. You will act as RS/SD/PI, overseeing assay development, validation, transfer, and sample analysis to ensure GxP compliance.

You will manage study teams, plan resources, troubleshoot assays, mentor staff, review documents, and support client communications.

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