Assay Development Manager – PCR-based IVD
Job Ref: 19779
Our client has developed 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 they further develop their PoC solutions through assay development and product refinement, they have an opportunity to reach millions of people who currently have limited access to existing diagnostic technology.
They are looking to strengthen their 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 their 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 assay program to ensure effective and timely delivery.
- Responsible for the supervision and development of relevant scientists.
- Direct and manage implementation of documentation and ISO 13485 compliance, with ownership of driving the programme’s 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
• 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 roll your sleeves up and participate in the daily duties when required
• Strong analytical and presentation skills
• Effective managerial gravitas to be the 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 are required, and familiarity with sequence alignment and statistical analysis packages.
Location: North West
Salary: Attractive, negotiable salary + excellent benefits
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