Executive / sr. executive - technology transfer

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

Ph D 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 Ph D, 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

Thorough understanding and practice of Quality Management System (QMS), Quality Control, Quality Assurance, GMP, GLP, ISO, FDA, Risk Management

Experience of carrying 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.

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

Timely delivery, excellent technical communication skills.