CAREERS AT EXTHERA MEDICAl
Reporting to Production Manager, the Manufacturing Chemist performs hands-on synthesis and conducts in-process analysis in accordance with the ExThera Medical Quality System and established operating procedures. The Manufacturing Chemist will play a role in supporting the daily production of the ExThera Medical’s products. Ensure that all raw materials are available and ready for use in manufacturing. Ensure that all equipment and ancillary equipment are clean and ready for use. He/she will also assist, as needed, in the assembly of medical devices and prototypes in a clean room environment.
Duties & Responsibilities
- Perform hand-on chemical synthesis according to the ExThera Medical Quality System and established Standard Operating Procedures.
- Responsible for making sure that all required raw materials for products to be made are available and released for use in manufacturing.
- Responsible for dispensing the required raw materials for the synthesis and making sure that reactor and ancillary equipment are clean and ready for use.
- Responsible for sampling and in-process monitoring of the synthesis. Must be able to interpret the analytical test result during the synthesis.
- Responsible for ensuring that all equipment in manufacturing are routinely calibrated and functioning properly.
- Responsible for handling and proper disposal of Hazardous Waste and Non-Hazardous wastes in accordance with safety protocols.
- Responsible for maintaining good housekeeping in the Manufacturing Area.
- Responsible for recording all raw materials used in the Log sheet.
- Must be able to accurately follow the procedures and data recording that is required in the Production Document.
- Responsible for contributing to the revision of current SOPs when needed.
- Provides ongoing support of the manufacturing scale-up and development work.
- Must be able to assist in creating a high level of performance for the Manufacturing Group by consistently producing high quality products.
- Provide training to other manufacturing personnel
- Comply with all ExThera Medical safety requirements, including posted placards, SOPs and the Safety Manual.
- Adhere to ExThera Medical Quality System procedures and ISO 13485 standard.
- Assist in repair and preventive maintenance for manufacturing equipment and facility.
- Assist other personnel in daily Manufacturing or R&D duties.
- Assist in collecting data for the Key Performance Indicators
- Assist in developing a manufacturing processes that are capable of achieving design requirements from prototype into full scale manufacturing.
- Assist in the assembly of the medical devices and prototypes in a clean room environment.
- Assist in creating, executing and documenting manufacturing process/equipment validations consistent with requirements for standard operating procedures.
- Assist in technical troubleshooting.
- Perform other duties assigned to meet business needs
BA/BS Degree preferably in Chemistry or Chemical Engineering or relevant discipline Preferable work experience: 2 – 4 years in Chemical Manufacturing Environment that includes hands-on synthesis or formulation, working with basic chemical laboratory apparatus and plant equipment, weighing and dispensing chemicals.
Skills & Work Requirements
- Strong organizational skills.
- Strong attention to detail and accuracy.
- Critical thinking and problem-solving skills.
- Ability to provide innovative solutions to complex problems.
- Experience in manufacturing medical devices and working in a cleanroom.
- Knowledge related to regulatory requirements for GMP operations.
- Experience using standard MS Office software, particularly Word, Excel and PowerPoint
- CAD drawing software a plus
- Good communication skills.
- Must be easily adaptable to changing priorities and deadlines.
- Self-starter and a team player that will thrive in an entrepreneurial environment.