Job
Description
Role objective We are looking for experienced candidate to carry out and end-to-end design implementation/technology transfer activities from conceptualization in R & D to production in Manufacturing. The candidate will also oversee and troubleshoot the manufacturing of Molbio’s PCR products, peripherals, and associated consumables. The major objective will be transfer of technology through appropriate design transfer and validation processes. Responsibilities Collaborate with R&D to understand the technology of new product assembly, review the design transfer file and enable the introduction of the new products in the manufacturing lines. Carry out feasibility studies for scale up manufacturing of new products before locking stage of design file by R&D. Develop detailed design specifications and documentation, ensuring clarity for manufacturing and regulatory submissions. Identify and mitigate risk associated with design and implementation projects, such as technical feasibility and regulatory hurdles Planning and execution of product as well as process validation Validation activities such as Design file review, protocol design and review Validation of method, equipment, software, raw/packaging material, facility Troubleshooting of issues faced by production and quality department Work on the effective manufacturing strategy and scalability with executive team Keep abreast of latest manufacturing technologies and methodologies and implement appropriate solutions. Ensure data analysis of manufacturing to improve productivity, quality and maintenance of machines. Ensure compliance with local and international laws and regulations. Education PhD in Life Sciences (Microbiology, Biotechnology, Molecular Biology, Biochemical Engineering, Biomedical Engineering, Medical Devices, Chemical Engineering, Clinical Pathology, Pharmaceutical Sciences, etc.) domain. Master’s candidate with suitable industry experience. Experience Sr. Executive - 2-5 years after PhD, 6-8 years after Masters Executive – Fresher PhD, 2-4 years after Masters in medical devices (preferably in POC IVD) industry with comprehensive understanding regulations such as CDSCO, ISO 13485, IVDR, MDSAP. Thorough understanding of the RTPCR related R&D processes and Design transfer activities. Skills and competencies Thorough understanding and practice of Quality Management System (QMS), Quality Control, Quality Assurance, GMP, GLP, ISO, FDA, Risk Management Medical devices/IVD product development (ideation, design input, process, output, verification, validation) Process development, automation, product validation processes Lean six sigma, production management Statistical process control, data analysis and interpretation Strategic thinking, superior analytical skills, exceptional problem-solving ability and attention to detail Functional/domain knowledge in POC medical devices/IVDs Attention to detail, timely delivery, excellent technical communication skills Show more Show less
