Research & Development Specialist

The Research and Development Specialist is responsible for the design, development and validation of analytical procedures. The post holder is responsible for the study management of method development, validation and investigational studies ensuring their effective implementation.

RESPONSIBILITIES

• Develop validation plans, validation summary reports, stability summary reports, correlation plans and correlation summary reports to meet regulatory requirements.
• Provide supporting information to Scientific Affairs in the evaluation of appropriate testing and/or methodology.
• Liaise with technical staff on feasibility of testing for new study requirements.
• Provide pricing as needed to Proposals team.
• Selection of appropriate test methods; research / identify suppliers of laboratory consumables and equipment options for new tests to support clinical trials opportunities.
• Facilitate assay development, conduct instrument validations and implement new testing to meet the needs of clinical trials protocols, clients and regulatory requirements.
• Responsible for assay / panel pre-validation and validation and correlation testing globally.
• Ensures all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP) etc.
• Perform the investigation and corrective action for assay troubleshooting and proficiency testing failures.
• Assess the impact of manufacturer / vendor communications and complete associated documentation.
• Provide study management and direction of laboratory teams for the implementation of analytical method validations.
• Provide supportive information for consultation and technical support to clinical trials clients and operational staff.
• Responsible for communications (meetings, calls audits etc.) with clients and formulate responses as required.
• Prepare Standard Operating Procedures (SOPs) for newly developed test procedures and relevant documentation as necessary.
• Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control) as appropriate within the required time frames.
• Participation in all activities that seek to ensure compliance with GCP guidelines and accreditation schemes (e.g. CAP).
• Preparation of documentation for and participation in internal and external audits (client and regulatory).
• Comply with policies for the safe, secure and confidential processing and storage of patient / client data and other laboratory information.

REQUIRED EXPERIENCE

• BSc (or equivalent) or higher in a relevant scientific subject.
• A minimum of 4 years’ experience within a laboratory environment required.
• Proven experience with external client interactions and managing deliverables from a laboratory, scientific, or technical standpoint.
• Demonstrable experience of managing validation activities within a laboratory setting (clinical laboratory experience highly preferred).
• Strong analytical, problem-solving and communication skills.
• Highly organised with the ability to manage multiple projects simultaneously.
• Ability to interpret complex technical information and translate findings into clear recommendations.

PHYSICAL REQUIREMENTS

S - Sedentary Work - Exerting up to 10 pounds of force occasionally. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.