Assistant Manager will be responsible for research & development of ELISA/CLIA, lateral flow test and Molecular biology techniques to ensure the addition of new products to fill the gap in portfolio for the business growth. The incumbent will be responsible for developing new products, providing technical and scientific support to production and QC team and perform clinical validation / evaluation of existing products. Education: MSc. / Ph.D in any field of Life Sciences (eg Biotech, Microbiology or Biochemistry) Experience: 6+ years of Research experience in IVD R&D (Field of Immunology/ELISA/Anti Body Production/Genetic Engineering/Cell Culture) Skills/Competencies: Expertise in developing Diagnostic kits such as ELISA, rapid card test, protein expression and purification. Scientific & Technical knowledge in diagnostic/life science business for research and development of diagnostic products. Designing & prototyping various diagnostic products by gaining an advantage over competitors in the market. Working knowledge with CDSCO /MDR 17 guidelines How you will thrive and create an impact: R&D team management and project assignment: Planning management of projects, maintaining timelines and establishing close connection with team and regular updates with all internal (Production & Quality) and external stakeholders (Regulatory, Business and Marketing). Handling lifecycle of projects: Designing new R&D project and its execution plan (Development, Evaluation and Technology transfer); Improvement plan as per market input and its execution. Project alignment as per business requirement: Market requirement analysis upon discussion with sales and marketing team to prepare inputs for R&D and feasibility mapping. Project costing and R&D budget planning Maintenance of company s Intellectual property (IP) Training: Safety; Scientific/Technical; Regulatory and compliance etc DEPARTMENT SPECIFIC/ON-GOING FUNCTIONS : Handling the R&D projects for their design & development, process optimization, clinical trials, technical trouble shooting, documentation, cost analysis of new products and their quality standard. Vendor identification, finalization, negotiation and sourcing of key RM/PM/equipment to be used for new product development. Reviewing the potential of upcoming projects/technologies/ products in terms of market potency, competency, costing, timeline and their scope. Preparation and documentation as per ISO 13485 and ensuring compliance. Maintain the R&D data and technology-oriented methodologies as per the company policies. Keep recording the raw R&D data in proper manner. Technical and scientific support to R&D, production, PMT team for related projects and activities. Monitoring of in-house developed products from market and update on technological advancement
