- Industrial Experience: Minimum of 5 years of experience in in similar position in
- IVD industry with a track record of development of commercialisable products.
- He/She must have knowledge and experience of preparing dossiers for Regulatoty
- submissions and Tech-transfer to production dept. as well as planning and
- budgeting of R&D projects.
- Main Area of expertise: Immunological Diagnostic test development (Elisa and
- Rapid tests) for infectious diseases.
- Secondary Area of expertise: Basic knowledge of Production and purification of
- Monoclonal antibodies and recombinant antigens.
Expected Role of Manager R&D :
1. To guide and supervise the development projects of various Elisa and rapid
tests and ensure their completion as per agreed timelines.
2. To train R&D technical staff in various basic techniques in Immunology.
3. To steer R&D activities to fulfil and address market needs and transfer the
developments for improvements of existing products, scale up and
commercial production to the manufacturing department by properly
documented Tech Transfer process.
4. To prepare R&D related files (Design dossiers) for submission by Regulatory
Dept. for Regulatory compliances
5. To prepare plans and budgets for R&D activities and present the same to
1. Recruitment and training of staff to maintain the R & D capability of the
company at optimum level.
2. Guide R&D projects and achieve results by working within budgeted
expenditure. Also co-ordinate with marketing team and with manufacturing
departments to address market needs.
3. Development of new products and effective transfer from lab to production
and provide trouble shooting support.
4. To prepare Tech-transfer dossiers for products developed by R&D to
5. To prepare dossier for submission for Regulatory compliances
6. To prepare plans and budgets for R&D activities and present the same to