Technology Transfer Lead

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.
• Identify and mitigate risk associated with design and implementation projects, such as technical feasibility and regulatory hurdles
• Planning and execution of product and process validation
• Validation activities such as Design file review, protocol design and review
• Validation of method, equipment, software, raw / packaging material, facility, user
• 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 (Molecular Biology, Chemical Engineering, Microbiology, Biotechnology, Biochemical Engineering, Biomedical Engineering, Medical Devices, Clinical Pathology, Pharmaceutical Sciences, etc.) domain.

Experience

2-5 years after PhD, 6-8 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