Lead Scientist (Validity & Compliance)

Cambridge, UK

Owlstone Medical has a new Lead Scientist position available within our Analytical Validity and Compliance group to provide technical leadership across a range of analytical platforms and associated equipment and data systems.

The Lead Scientist is expected to be a conduit between development and operational teams, leading continuous improvements projects and providing subject matter expertise to users of analytical platforms, to ensure hardware, methods and procedures are being optimally developed and deployed for delivery of business object.

KEY TASKS / ACCOUNTABILITIES

  • Drive implementation of a fit-for-purpose quality control strategy and tools for analytical platforms, to improve system understanding, efficiency and decision making through real time analysis of data, reducing data integrity risks
  • Lead instrumental troubleshooting activities and root cause analysis investigations
  • Work closely with the Information Science and IT departments to define and implement a unified strategy for collection, storage and management, and presentation of data from Owlstone’s analytical platforms
  • Oversee introduction of new analytical instrumentation, ensuring adherence to the realisation process and ensuring equipment is qualified and can be deployed for delivery of business objectives
  • Define and implement instrument preventative maintenance activities and schedules
  • Lead knowledge transfer activities, including the training of new users of analytical platforms
  • Act as a technical point of contact for key suppliers.
  • Provide technical specifications for laboratory and infrastructure projects to ensure facilities and services are fit for purpose
  • Support execution of analytical method transfers between R&D and operations
  • Lead efforts to industrialise operational methods and technologies
  • Ensure the Analytical Services Group are supported in their day-to-day operation with relevant deviation and process improvements oversight
  • Identify and lead opportunities for continuous improvement throughout Owlstone's analytical operations; reducing variation in processes, improving efficiencies, robustness of methods, platforms and service quality.
  • Work within and identify improvements to Owlstone’s Quality Management System with regards to laboratory and instrumentation processes and management of non-conformances
  • Provision of mentoring and development of the wider Analytical Science groups, including consultation on and review of technical requirements specification, experimental briefs, plans, study protocols and reports, in partnership with the relevant Line Managers.
  • In addition to this, you will also be expected to play an active role in the success of the Analytical Science groups. This could include acting as a technical reviewer for projects, running or contributing to development seminars and deputising for more senior staff as required.


COMPETENCIES

The following competencies form the core strengths of the Analytical Science department. You will have an in-depth knowledge of the below competencies in complex situations and will be able to critically evaluate, adapt and add to them, as necessary. You will be recognised as an expert by other senior professionals and will be expected to demonstrate a practical application of them in complex situations as well as draw upon examples where others have sought your guidance in their application.

  • Research - The ability to conduct objective, logical, and systematic analysis of phenomena to permit the accumulation of reliable knowledge
  • Protocols – The ability to follow and validate protocols and understanding of the importance of spotting, raising and resolving non-conformities, and tracking through to a determination of root cause
  • Data Management- Understanding the pertinency of the data collection, data entry and verification process and data management systems
  • Dissemination of Findings – The ability to report results using the various dissemination formats available for different target audiences. Understands the importance of clear communication adapted in a manner suitable for the audience
  • Analytical Concept - The understanding of the rationale, theory, and subject matter in a particular scientific discipline to allow the appropriate application within an analytical role. (e.g Applying knowledge of basic chemical concepts and theories to set research questions with appropriate confidence limits, choose correct analysis technique and proficient instrument operation).
  • Facilities and Safety – The ability to assess the appropriateness of laboratory function against business deliverables and justify / implement the change when required. Also understands the importance of compliance with processes that are there to identify and mitigate workplace hazards
  • Pre- analytical – The ability to design, implement and evaluate the appropriateness of sampling methodologies and sample preparation
  • Analysis – The ability to perform routine and non-routine analysis and understand when the applied technique is fit for purpose and what associated quality control activities are required to ensure that the technique remains within established ranges and limits. The ability to effectively troubleshoot when technique deviates from those established ranges and limits.
  • Critical evaluation of data – The ability to evaluate and ensure the accuracy of data as well as spot real and non-real trends to provide an answer with confidence limits to either fulfill a customer contract or research question

Requirements

EDUCATION & TRAINING

  • The successful candidate is likely to have a higher degree in a relevant analytical science or equivalent discipline

EXPERIENCE / KNOWLEDGE

Essential

  • GC-MS method development experience
  • Experience leading the delivery of continuous improvements projects within an operational environment
  • Experience of instrument fault-finding, maintenance, and repair
  • Experience of user training and management
  • Working knowledge of IT systems and/or data systems relevant to implementation in analytical laboratories

Desirable

  • TD-GC-MS method development experience
  • GC-MS method validation experience
  • Experience managing relationships with analytical platform vendors
  • Experience of installation of and/or managing use of a commercial chromatography data system
  • Working in ISO 17025 or GxP environment

PROFESSIONAL SKILLS

  • Reasoning and problem solving
  • High attention to detail
  • Excellent verbal and written communication skills
  • Flexible approach to changing priorities
  • Ability to influence and negotiate with stakeholders
  • Organisation & record keeping

Benefits

About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about the metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in-breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk.


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