Mass Spectrometry Director
Owlstone Medical’s mission is to save 100,000 lives and save health care providers $1.5B. With several major projects underway to develop disease screening and diagnosis based on detection of metabolic products in breath.
We are currently seeking a Mass Spectrometry Director in Cambridge, UK. The successful candidate will provide technical leadership across all of our MS-based Breath Biopsy method and assay development work, from early pre-clinical stages to commercial product development, targeting both research and In-Vitro Diagnostic (IVD) use.
The MS Director will be an accomplished leader with the ability to interface with a range of stakeholders, including external collaborators/consultants, to provide development support, and conduct analytical characterization, similarity/comparability studies to support regulatory filings and reach project milestones. The MS Director ensures the analytical methods are suitably qualified/validated for use in GCP and GLP laboratory environments, reviews and approves study reports and QC test methods, develops strategies to ensure effective achievement of scientific objectives, and monitors and evaluates completion of tasks and projects.
The Mass Spectrometry Director will also develop budgets for capital expenditures and labour, oversee selection, performance management, mentoring, and career development for the team. They will act as an advisor to top management on corporate research and development direction and serve as a critical participant in the review of medical projects throughout the company.
Areas of responsibility
- Provide strategic leadership to help steer the development of Breath Biopsy as a tool for research, monitoring and diagnostic use
- Provide technical leadership for MS assay development and assay validations, consistent with the overall product development plan for assays used in the Owlstone Breath Biopsy laboratory and applicable regulatory requirements
- Advise top-level management on corporate research and development direction
- Provide critical input to the review of medical projects throughout the company
Actively participate in, and seek input from, cross-functional teams (including algorithm, software, clinical, manufacturing, quality, and regulatory teams) to ensure company-wide alignment with strategic goals
- Supervise creation of validation documentation that meets standards required for inclusion in regulatory filings
- Regularly report to the senior leadership team and other key stakeholders on progress, issues, risks and opportunities for the business
- In-depth knowledge of mass spectrometry used in a commercial test setting
- Strong demonstrated ability to lead and manage scientists/research associates
- A strong track record of developing and implementing MS-based assays across multiple clinical laboratories
- Experience with regulated LC/GC MS assay development, including transfer, verification, and validation activities necessary for research and diagnostic product commercialization
- Experience developing and launching MS-based assays compliant with FDA or CE-IVD requirements is strongly preferred
- Excellent technical scientific writing, communication, and organizational skill
The successful candidate
- Will be able to demonstrate hands-on team leadership skills
- Must be self-directed, organized and conscientious
- Will be proficient in executing design transfers and in-process quality checks
- Will have the ability to solve complex technical problems
- Must have demonstrated the ability to work under pressure and with short deadlines to accomplish objectives
- Will communicate effectively with technical and non-technical personnel
- Will think strategically when planning, managing teams, and managing processes
Owlstone Medical has developed a breathalyzer for disease.
Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.
Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% - unfortunately there are still far too many people detected at late stage.
The Owlstone group also commercialises 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 Defence.
We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.