Lead Scientist, Large Molecule Bioanalysis (PK)

Simbec-Orion Group; Merthyr Tydfil; On-site; GBP 90,000 - 130,000; Full time

Job summary

Simbec-Orion is seeking a Principal Scientist to lead large molecule bioanalysis within our Laboratory Services team, supporting PK, immunogenicity and biomarker studies across oncology and rare disease programmes.

You'll own study design and execution from client onboarding through final report, acting as the technical authority on assay strategy for complex biotherapeutics and mentoring junior scientists developing their expertise.

Qualifications

• Experience in large molecule bioanalytical assays in regulated labs (GCP/GLP/GMP).
• Proven track record leading PK and immunogenicity assay development.
• Ability to review technical docs to GxP standards and ensure data integrity.
• Experience managing study timelines under deadlines.

Responsibilities

• Lead assay development and validation for large molecule bioanalysis.
• Provide technical direction on assay strategies for complex biotherapeutics.
• Own studies from client onboarding to final report.
• Mentor scientists in large molecule bioanalysis.
• Represent Laboratory Services to clients, auditors, Sponsors.

Skills

Large molecule bioanalysis

Assay development & validation

LC-MS/MS workflows

GxP regulatory knowledge

Documentation review (GxP)

Study project management

Education

MSc or PhD in a relevant field

Tools

LC-MS/MS

Ligand binding platforms

Job description

Simbec-Orion is seeking a Principal Scientist to lead large molecule bioanalysis within our Laboratory Services team, supporting PK, immunogenicity and biomarker studies across oncology and rare disease programmes.

You'll own study design and execution from client onboarding through final report, acting as the technical authority on assay strategy for complex biotherapeutics and mentoring junior scientists developing their expertise.