The individual will conduct cGMP manufacturing of a cell-based product. This includes validation and devopment 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 including packaging and disposing of biohazard waste per established procedures.
- 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 other duties as required.
- Requires Associate Degree with 0-2 years’ experience. May have a Bachelors degree; however not required.
- Experience with cell culture and/or molecular biology and aseptic techniques is strongly 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.
Majority of work is sedentary with sitting, standing and bending. Some occasional physical demands such as: pushing, pulling, and lifting up to 30 lbs. Good dexterity and balance required. Work will require working with Biohazardous, small quantities of chemical materials, as well as ultra-cold temperatures while wearing personal protective equipment.
CoImmune, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.