The individual will conduct cGMP manufacturing of a cell-based product. This includes validation and development runs under cGMP and assistance in technology transfer of novel products. All activities will be performed in a cGMP-compliant environment
- Execute procedures to manufacture cell therapy products ensuring that production batch records are completed at the highest standards according to Company policies and procedures.
Assist with review and organization of completed batch records, address deviations and support investigations as necessary.
- Perform daily clean room activities such as equipment/material preparation and cleaning/sanitization of equipment and rooms.
- Assist in ordering and transfer of materials and maintain supplies adequate for production demands. Stocking of non-lot controlled materials and cleanroom garments.
- Assist with execution of environmental monitoring of air, surfaces and personnel in classified areas.
- Provide assistance with authoring and revision of Batch records, SOPs, Temporary changes, Item Specifications and other cGMP documentation.
- Collaborate with and assist other groups with projects by executing protocols associated with validation, technology transfer, etc.
- Perform Biohazard waste packaging and disposal per established procedures
- Perform other duties as required.
- An associate degree or higher with 2-3 years of relevant experience.
- Experience with cell culture and/or molecular biology and aseptic techniques is strongly preferred.
- Hands on experience working in GMP clean room is preferred.
- Good communication skills to clearly convey complex information and ensure proactive communication in timely manner.
- Must have strong computer skills.
- Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other groups.
- Must have initiative, high attention to detail, and the ability to multi-task
- Flexibility with work schedules and duties including necessary extended hours, weekends and holidays
- Ability and willingness to be regularly, predictably, and reliably at work