Analytical R&D Specialist: Method Validation & Trials

ACM UK; York and North Yorkshire; On-site; GBP 63,000 - 85,000; Full time

Job summary

Rochester Regional Health seeks a Research & Development Specialist to design, develop and validate analytical procedures for clinical trials and regulatory submissions. You will oversee method development, validation plans, and study management in a fast-paced laboratory setting.

The role requires strong analytical and communication skills, experience with validation activities, and the ability to manage multiple projects while ensuring compliance with GCP/GLP/GCLP and CAP guidelines.

Qualifications

• BSc (or equivalent) in a relevant scientific subject.
• Minimum 4 years' experience in a laboratory environment.
• Experience managing validation activities in a laboratory setting (clinical laboratory experience preferred).
• Experience with external client interactions and delivering lab deliverables.
• Strong analytical, problem-solving and communication abilities.

Responsibilities

• Develop validation plans and validation summary reports to meet regulatory requirements.
• Provide supporting information to Scientific Affairs for evaluation of testing methodologies.
• Liaise with technical staff on feasibility of testing for new study requirements.
• Select appropriate test methods and identify suppliers for new tests in clinical trials.
• Facilitate assay development, conduct instrument validations and implement new testing for trials.

Skills

Analytical skills

Problem-solving

Communication skills

Organisation & multitasking

Education

BSc in a relevant scientific subject

Job description

Rochester Regional Health seeks a Research & Development Specialist to design, develop and validate analytical procedures for clinical trials and regulatory submissions. You will oversee method development, validation plans, and study management in a fast-paced laboratory setting.

The role requires strong analytical and communication skills, experience with validation activities, and the ability to manage multiple projects while ensuring compliance with GCP/GLP/GCLP and CAP guidelines.