Principal Scientist - Large Molecule Bioanalysis

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

Our Mission

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

The Role

We're 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 bring deep technical expertise in large molecule quantification, whether through ligand binding assays, LC-MS/MS peptide and protein workflows, or both, 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 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.