MiniFAB is a leading provider of product development and manufacturing services to the global medical diagnostic market. Due to continued growth, an opportunity has arisen for a Manufacturing Scientist to join the team on a full-time basis
Reporting to the Head of Manufacturing, you will be supporting manufacturing activities by preparing reagents and assisting with assay technology transfer from Product Development to Manufacturing. The successful candidate will also be responsible for reagent preparation process validation and continuous improvement initiatives to improve yield, reliability, robustness, and safety. Overall, your exceptional attention to detail, scientific knowledge, and understanding of quality control will bring about the production of high quality reagents.
Duties of the role will include but are not limited to:
- Preparation of reagents in a GMP compliant manner to meet production schedules
- Act as the primary point of contact for technical and operational issues related to reagent preparation
- Lead the process development, process optimization and process standardization activities for assay transfer into manufacturing
- Coordinate and perform routine maintenance of scientific instrumentation
- Ensure batch documentation is completed on time and within quality standards
- Assist with quality investigations related to product and processes
- Consult into development projects in order to deliver a manufacturable product
- Management and supervision of staff, ensuring your responsible team members adhere to quality requirements
Essential Skills and Requirements:
- Tertiary qualification in biochemistry, molecular biology or similar with a minimum of 5 years of additional experience in a related field
- Solid technical knowledge, excellent communication skills, attention to detail, and problem-solving skills
- Prior experience working within a GMP manufacturing environment with demonstrated understanding of quality and processes. Experience with FDA/TGA is advantageous.
- Proven hands-on experience preparing reagents. Prior experience with antibody conjugation techniques will be highly advantageous.
- Demonstrated ability to develop and validate analytical methods
- Excellent organization, presentation, and time management skills
- Ability to work independently and as part of a team
If your skills and experience match the above criteria, then please apply with your CV and covering letter in Word Format.
Questions can be referred to Louise Bastow at Fuse Recruitment on 0403 202 811.