This position is responsible for the planning, implementation, and maintenance of manufacturing methods, processes, and operations for current and new product lines, as well as contributing to the improvement of production capabilities. The Manufacturing Scientist is also responsible for understanding product specifications, troubleshooting technical problems, and implementing process improvements.
Produce products, kits, and reagents that meet product specifications and timelines.
Accurately and completely record production and in-process testing results in approved batch record forms and work order documents.
Manage inventories, supplies, and equipment in order to achieve production plans.
Utilize technical knowledge to make detailed observations and analyze data to ensure they are within operating parameters.
Troubleshoot, identify, and resolve problems in manufacturing processes.
Assist in revising SOPs, batch records, and other production related documentation in accordance with the requirements of the GMP Quality Management System.
Assist in the review and validation of product development protocols, and implementing these procedures through the use of written approved work instructions.
Assist in maintenance and calibration of equipment that are used in production using established or manufacturer-supplied procedures.
Communicate production status to the Manufacturing Manager in a timely manner, including any operational issues.
Assist in scheduling and preparation of purchase orders of raw materials to ensure timely delivery of products.
Assist in optimizing and improving existing products and manufacturing processes to assure highest product quality and reduced scrap rate.
Education: Bachelor’s degree in a Life Science field (Master’s degree 1+ years of experience).
Experience: 3+ years of related scientific experience, including