Process Development Lead

**Process Development Lead**

MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

**Job Location**: Tukang

**Job Summary**

Besides managing and coordinating process validation activities for IVD products, this person will provide process support in troubleshooting, nonconformance investigation of production processes and evaluation of product impact as part of a nonconformance/deviation or engineering change order.

**Roles and Responsibilities**
- Manage product technology transfer activities internally with R&D (Product Development), Product Management and Manufacturing Ops functions, or contract manufacturing activities with external customers.
- Manage communication with internal stakeholders and/or external customers on technology transfer timelines.
- Be the driver of process design ensuring the technical requirements are met for Form, Fit & Function of the product - establishing the design requirements and develop the manufacturing process, bill of materials, artwork for labels and packaging during NPI to ensure a smooth transition to production team.
- Analyze and optimize manufacturing processes to minimize waste, improve efficiency, and reduce overall Cost of Goods Sold (COGS).
- Lead product stability studies to extend shelf life, reducing scrap costs associated with expired or unsellable inventory
- Evaluate and optimize raw material usage by balancing lot sizes, minimizing waste, and ensuring cost-effective production.
- Support manufacturing operations and work with other departments to resolve technical issues with manufacturing equipment and process.
- Assist with nonconformance impact assessments and root cause analysis.
- Support change management and implementation for changes to manufacturing process or process equipment or associated systems by providing technical assessment.
- Propose process/product/device improvement opportunities and/or corrective actions to increase output, maximize capacity, reduce costs and increase process robustness while maintaining regulatory compliance.
- Guide and train other manufacturing science and/or production personnel on new processes or workflows.

**Desired Skills and Competencies**
- Bachelor/ Master of Science/ Engineering or equivalent in Biotechnology, Biochemical, Biochemistry, Analytical Chemistry, Molecular Biology/ Life Science related courses.
- Appropriate experience may substitute for education.
- Preferably with at least 3 years experience in the biotech/pharma manufacturing sector.
- High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment.
- Able to work with external suppliers or partners to identify, design and develop feasible manufacturing solutions.
- Able to handle technology transfer of several products at different status of Design and Development.
- Excellent organizational skills and attention to detail required.
- Good logical thinking and reasoning ability.
- Good Documentation Practices and ability to write protocols and procedures
- ISO 13485 experience would be an added advantage.

**This position is based in Singapore.