This role is responsible for the undertaking of research and development activities to support contracted pharma projects to develop companion diagnostics IVDs, specifically to manage up to 3 Senior Scientists who will each lead one (1) pharma collaboration. They will be responsible for providing guidance to and developing junior staff on technical and assay development. They will be proficient in effective management of the product development process and will possess outstanding communication skills.
• Manage up to 3 Senior Scientists, specifically providing guidance for the feasibility, development and verification phases of assay development for a Companion Diagnostic Immunohistochemistry (IHC) or In Situ Hybridization (ISH) In Vitro Diagnostic assay
• Support project teams in discussion with pharma partner.
• Work closely with project management to ensure execution of project plans with an emphasis on Revenue Recognition, On Time Delivery of project milestones and efficient team member utilization
• Ensure Design History Files are assembled in accordance with applicable protocols and work instructions
• Ensure the Design Process procedures and other related procedures are effective and efficient to support aggressive and evolving timelines to support the Pharma Partnerships team as well as being compliant with FDA regulations and EU CE-IVDD directives
• Provide R&D voice for regulatory strategy and discussions, submissions to regulatory agencies.
• Oversee technical output of project team to ensure data quality
• Further collaboration and communication between R&D departments across the company
• Support a culture of continuous process improvement and advise process improvement teams.
Ph.D.in molecular biology, biochemistry, chemistry, genetics or related field
• At least 7+Years industry experience gained within an IVD development environment with increasing management responsibility. Experience with IHC and ISH assay development is preferred
• Experience with FDA or EU CE-IVD quality requirements and the preparation of relevant documents for the submission of product information to these agencies.
• Strong experience in IVD Product Development, preferably with technical expertise in IHC, ISH assays on automated staining platforms
• Demonstrable experience of providing guidance and mentorship within teams to drive the successful development and release of products through implementation and an ability to drive improvements.
• Excellent communication skills with an ability to evaluate and articulate complex scientific and business issues and implement solutions
• Outstanding analytical and strategic thinking skills
• Very strong drive for results and on-time delivery to aggressive timelines
• A passion for employee development