Senior Analytical Development Scientist — GMP Method Leader

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

Benefits offered by this job

Competitive benefits

Ongoing development

Dynamic work environment

Job summary

Hyper Recruitment Solutions Ltd in the United Kingdom is seeking a Senior Analytical Development Scientist to lead the design, qualification, and validation of analytical methods supporting drug substance and drug product from preclinical through late‑stage development.

You will coordinate technology transfer to CMOs/CROs, support release and stability testing, investigate GMP deviations, and mentor Assay Development Scientists in a fast‑paced, regulatory driven environment.

Qualifications

• Degree or higher in a biological science; post-graduate qualifications preferred.
• 5–10 years of industry experience in a cGMP quality environment.
• Strong regulatory knowledge for analytical testing and product development.

Responsibilities

• Develop, qualify and validate analytical test methods and oversee tech transfer.
• Support release, stability testing and GMP investigations with CAPA and OOS.
• Evaluate and implement new analytical technologies within the dept.
• Support process development, specifications, regulatory filings and authority inquiries.
• Provide expert input during troubleshooting, data analysis and cross-functional meetings; supervise junior staff.

Skills

PCR

ELISA

Cell-based potency assays

Education

Biology degree

M.S./Ph.D. preferred

Job description

Hyper Recruitment Solutions Ltd in the United Kingdom is seeking a Senior Analytical Development Scientist to lead the design, qualification, and validation of analytical methods supporting drug substance and drug product from preclinical through late‑stage development.

You will coordinate technology transfer to CMOs/CROs, support release and stability testing, investigate GMP deviations, and mentor Assay Development Scientists in a fast‑paced, regulatory driven environment.