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JOB TITLE: R&D Team Leader – Infectious Disease Assay Development REPORTING TO:
R&D Manager MAIN DUTIES / RESPONSIBILITIES:
- Leadership of a Team of Development Scientists.
- Development of immunoassays assays for infectious diseases in compliance with Design Procedures for regulated products.
- Upgrade of existing assays to meet changing market requirements.
- Preparation of raw materials for transfer to production for kit manufacture.
- Leadership of multiple project teams according to project management principles and procedures.
- Provide support to marketing, customers, manufacturing and QA/QC on technical issues,
presentations at conferences and to customers. - Training staff.
- Compliance with the Quality System as required.
PRINCIPAL QUALIFICATION REQUIRED:
Third-level plus PhD, MSc, or equivalent. Other candidates with extensive development experience are encouraged to apply. WORK EXPERIENCE:
- In-depth experience in development and/or manufacture of human IVD products in a regulated environment.
- Leading and motivating people.
- Working knowledge of the full product development cycle from feasibility to market, including clinical trials, regulatory and transfer to manufacturing.
- Knowledge of FDA and IVDD requirements for new product registrations is an advantage.
- Using structured project management tools, ideally in a project lead role.
KEY SKILLS:
- Full range of laboratory techniques associated with the role of developing immunoassays.
- Knowledge of design control procedures, GMP, GLP.
- Organisation and time management.
- Ability to deploy resources effectively.
- Problem solving.
- Self motivated, responsive and goal-seeking.
- Listening, written and oral communication skill.
- Interpersonal skills, presentation skills are important.
PERSONAL ATTRIBUTES:
- Decisive and highly self-motivated.
- Ability to work to deadlines and on own initiative.
CONTRACT TYPE
Full-time Permanent. |