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# Principal Scientist - Large Molecule Bioanalysis

- **Company:** Mission Simbec-orion
- **Location:** Merthyr Tydfil, UK
- **Contract:** Permanent contract
- **Skills:** Data Integrity, GXP
- **Published:** September 21, 2026
- **Apply:** https://www.apply4u.co.uk/jobs/principal-scientist-large-molecule-bioanalysis/47827211

## About the Role

a regulated laboratory environment (GCP, GLP and/or GMP) Proven track record leading assay development and validation for PK and/or immunogenicity studies Technical expertise in ligand binding assay platforms and/or LC-MS/MS for protein/peptide quantification Strong understanding of regulatory expectations for biotherapeutic bioanalysis Demonstrable ability to review and approve technical documentation to GxP standard Experience managing study timelines and priorities under deadline pressure DESIRABLE MSc or PhD in a relevant scientific discipline CRO or clinical trial experience Experience with biosimilar comparability studies Six Sigma / Lean or project management certification Experience supporting audits and regulatory inspections Mentoring or informal line management experience About Us Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team. We're dedicated to bringing the latest advances in
science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you. #J-18808-Ljbffr

## Description

and take scientific ownership of studies from client onboarding through to final report. You'll be the technical authority on assay strategy for complex biotherapeutics, working closely with clients and Sponsors on study design, and mentoring scientists building their large molecule expertise. Key Accountabilities Lead assay development and validation for large molecule bioanalysis (PK, ADA, NAb, biomarkers as applicable to platform) Provide technical direction on assay strategy for complex biotherapeutic and biosimilar programmes Take scientific accountability for assigned studies: data integrity, regulatory compliance, and final reporting Review and approve protocols, validation reports, SOPs and study documentation Mentor scientists developing large molecule bioanalytical technique Represent Laboratory Services with clients, auditors and Sponsors, and support Business Development with technical input Skills Required ESSENTIAL Extensive hands-on experience in large molecule bioanalysis in