Tuberculosis Assay Development Manager
ROLE PROFILE – THE VISION
Genedrive®, is an affordable, real-time PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as TB or Hepatitis. As we further develop our Point of Care solutions through assay development and product refinement, we have an opportunity to reach millions of people who currently have limited access to existing diagnostic technology. Ultimately, Genedrive has the ability to change lives through rapid access to the benefits of molecular diagnostics.
As we ramp up our focus on delivering affordable point of care in vitro molecular diagnostics for addressing global infectious disease challenges, we are looking to strengthen our R&D team with the addition of a senior scientist with strong molecular biology and/or TB biology experience to lead the tuberculosis assay development program in order to maximise our chances for future success and global impact.
- Reporting to the Head of Assay Development, you will take the leadership for the development and management of the mTB assay program to ensure effective and timely delivery of the programme
- Responsible for the supervision and development of relevant genedrive scientists.
- Direct and manage implementation of documentation and ISO 13485 compliance, with ownership of driving the programmes’ Technical & Design History files
- Accountable for the overall project to achieve agreed time and performance milestones for the company
- Review data within the team and provide advice to meet project milestones effectively
- Maintain project documentations in accordance with internal and external requirements
- Transfer of TB development projects into manufacturing
- Good, clear communication with managers and directors
To perform the job successfully, the ideal individual should demonstrate the following competencies:
- Experience working within a Quality Management System required for ISO and CE/IVD standards
- Excellent leadership skills to coach and mentor team members and support their growth and career aspirations
- Willing to role your sleeves up and participate in the daily duties when required
- Exacting in your communication with good scientific understanding with ability to synthesize information and formulate effective arguments
- Strong analytical and presentation skills
- Effective managerial gravitas to be the TB program point of contact for internal and external stakeholders
- Strong ownership and accountability of projects, deliverables, and due dates.
- Strategic thinker with the ability to influence at a senior level
Ideal Experience Desired
- Scientific track record within the tuberculosis field
- Previous successful experience in the full life cycle of bringing a diagnostic assay through development and onto the market.
- PhD and/or significant equivalent experience, ideally gained in an in vitro diagnostics / molecular microbiology environment & using fluorescent based PCR methods
- Microsoft Word, Excel and PowerPoint is required, with familiarity with sequence alignment and statistical analysis packages.
- Occasional air travel for up to a week at a time may be required to our laboratory partners in Europe and India, but this would be intermittent at most.
How to apply:
You can find further information about us at http:///www.genedriveplc.com and then click on our Careers link.