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Date Added: Tue 17/01/2023

Research And Development Specialist

York, YO10, UK
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Company: ACM GLOBAL LABORATORIES

Job Type: Permanent, FullTime

SUMMARY

The Research and Development Specialist is responsible for the study management of method development, validation and investigational activities ensuring their effective implementation and completion. The post holder will support and coordinate global laboratory, technical, setup and support teams to drive activities ensuring that they are conducted with scientific rigour, the appropriate level of documentation and to the required timelines. The post holder will work with Operational Management and Research and Development to provide scientific support to ACM clients as well as the Scientific Affairs, Proposals and Business Development functions.

The role offers the opportunity to lead development and change within the business. You will be part of a successful team who help set the course and drive capabilities for the company. ACM offers comprehensive career pathways within an expanding company, whilst working in a friendly and collaborative workplace.

STATUS: Full-time (but other working patterns will be considered)

LOCATION: Hybrid

DEPARTMENT: Research & Development

SCHEDULE: Monday - Friday, days

ATTRIBUTES:

* BSc (or equivalent) or higher in a relevant scientific subject.

* A minimum of 4 years' experience within a laboratory environment preferred

RESPONSIBILITIES:

Technical. 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.

Operations. 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. Any other duties as defined and requested by Operational Management.

Quality. 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. 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. Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control) as appropriate within the required timeframes
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