Research & Development Specialist-Contract York, England
Job description
SUMMARY
ACM Global Laboratories is a recognised leader in global clinical trial testing and central laboratory services. Through wholly-owned facilities and our network of partner labs, we support clinical trials in more than 65 countries around the globe including, the U.S.A., the United Kingdom, India, and Singapore. ACM Global has a clear vision and core values to ensure delivery of actionable clinical insights that lead to therapies and treatments that provide health, healing and hope to patients around the world.
The Research and Development Specialist is responsible for the overall 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 provide scientific support to ACM clients as well as the Laboratory Operations, 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, Contract (but other working patterns will be considered)
LOCATION: Hybrid
DEPARTMENT: Research & Development
SCHEDULE: Monday - Friday
ATTRIBUTES:
- BSc (or equivalent) or higher in a relevant scientific subject.
- A minimum of 4 years’ experience within a laboratory environment preferred
- Clinical Chemistry background required
- Experience of working in a high throughput laboratory environment
- Use of analytical instrumentation (Roche systems 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 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 teams. Selection of appropriate test methods; research / identify suppliers of materials and equipment options for new tests to support new 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.
Operational. 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.
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.. Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control etc.) as appropriate within the required timeframes.
Job Types: Full-time, Fixed term contract
Benefits:
- Life insurance
- On-site parking
- Referral programme
- Wellness programme
- Work from home
Schedule:
- Day shift
- Monday to Friday
Ability to commute/relocate:
- York: reliably commute or plan to relocate before starting work (required)
Work Location: Hybrid remote in York
Reference ID: ACRDS0123
