POSITION DESCRIPTION: Cell Therapy Manufacturing Technician
REPORTS TO: Director of Cell Therapy Manufacturing
CATEGORY: Full-time exempt
Biorestorative Therapies (BRT) develops innovative biologics, primarily involving adult stem cells. The lead therapeutic product, brtxDISC™ (Disc Implanted Stem Cells), is an autologous cell therapy for the non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease and is intended for patients whose pain has not been alleviated by non-invasive procedures and potentially face the prospect of surgery. brtxDISC is injected into the damaged disc in an outpatient procedure. BRT plans on establishing its own manufacturing facility for the production of brtxDISC for its upcoming clinical trials, which are expected to start in late 2015/ early 2016.
The Cell Therapy Technician will have the responsibility of performing operations required for the manufacturing of cell-based products for use in human clinical trials. This includes following SOPs, production record instructions and using equipment properly for the processing of samples to yield an acceptable product. The position normally receives general instructions on routine work and detailed instructions on new assignments.
Primary job responsibilities include:
- The use of aseptic technique. Will spend a significant amount of time fully gowned in a clean room setting.
- Performing QC release testing for materials or products per specifications and procedures.
- Supporting pre-clinical research and development projects as needed to meet company objectives.
- Cell culture work associated with manufacturing operations as well as pre-clinical and development projects.
- Maintenance of lab facilities and equipment.
- Observe OSHA safety standards.
- Ensure accurate and timely completion of required documentation.
- Ability to follow GxPs and SOPs.
- Assist in writing documents such as SOPs, validation plans or reports and specifications as assigned.
- Develop problem solving skills.
- Ability to recognize problems with equipment or data but resolve issues with supervision.
- Four-year degree in biology or related scientific discipline with a minimum of 0-2 years laboratory experience.
- Experience with aseptic technique and working in a cleanroom would be preferred.
- Ability to communicate well orally and in writing. Computer literacy is required to perform scientific and written communications.
- Ability to work independently and in a team setting.
- Ability to work flexible hours with some night and weekend availability required.
- Capable of working on multiple projects at one time.
- Ability to function in an environment of changing priorities and directions as determined by corporate goals.
If interested, please send your resume and compensation requirements to: