Senior Analytical Development Scientist, Biotech Methods

Hyper Recruitment Solutions; England; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Competitive benefits

Development opportunities

Job summary

Hyper Recruitment Solutions is seeking a Senior Analytical Development Scientist for a leading biotechnology company in the UK. The role involves developing, qualifying and validating analytical methods for drug substance and product from preclinical to late-stage clinical development, ensuring regulatory compliance.

You will support product release, process development and collaboration with CMOs/CROs, leading a small team of assay scientists in a fast-paced, innovative environment.

Qualifications

• Degree in biological sciences or related field required.
• Post-graduate qualifications (M.S. or Ph.D.) highly preferred.
• Experience with regulatory requirements for analytical testing and development.

Responsibilities

• Manage development, qualification, and validation of analytical test methods.
• Oversee technology transfer per regulatory guidance (ICH).
• Support release, stability testing, and GMP investigations including CAPA and OOS.
• Develop strategies for evaluating new analytical technologies.
• Support process development activities including specifications and regulatory filings.
• Supervise Assay Development Scientists or Technicians and ensure timely delivery.

Skills

PCR

ELISA

Cell-based potency assays

Regulatory requirements

Project management

Cross-functional collaboration

Biochemistry

Education

Biological sciences degree

MS or PhD preferred

Job description

Hyper Recruitment Solutions is seeking a Senior Analytical Development Scientist for a leading biotechnology company in the UK. The role involves developing, qualifying and validating analytical methods for drug substance and product from preclinical to late-stage clinical development, ensuring regulatory compliance.

You will support product release, process development and collaboration with CMOs/CROs, leading a small team of assay scientists in a fast-paced, innovative environment.