Position Summary: This Cellular Therapy Technologist will provide technical support to programs within Ossium Health’s Manufacturing group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical manufacturing. This work will involve executing and documenting methods for the manufacture of bone marrow-derived products. It will also involve the implementation of new methods as designed by senior staff.
- Responsible for preparation of kits used for product procurement.
- Responsible for isolation of bone marrow cellular products from primary tissue for pre-clinical and clinical use.
- Participation in experiments designed to optimize or qualify bone marrow-derived product preparation processes.
- Interact closely with other departments within Ossium Health, including but not limited to Process Sciences, Manufacturing Operations, Quality Assurance, Quality Control, Clinical Operations and Regulatory Affairs.
- Assist in writing and reviewing development reports, Standard Operating Procedures (SOPs) and other quality related documents.
- Perform activities in accordance with current Good Practices (cGXPs).
- BS/BA in medical technology, life sciences, engineering or equivalent is required with at least 2-4 years of industrial or clinical work experience.
- Experience in aseptic and/or cell-culture operations in an industrial or clinical environment is required.
- A Medical Technology (MT) certificate from American Society of Clinical Pathologists (ASCP) is preferred.
- A working knowledge of safety, quality systems and quality assurance concepts is required, including the application of current Good Practices (cGXPs) as they apply to manufacturing and clinical processes.
- Must have a strong focus on quality, attention to detail, and results.
- Strong interpersonal, communication and problem solving skills are required as well as demonstrated ability to work effectively in cross-functional teams both internally at Ossium Health and externally at procurement sites.
- Experience with supply-chain and inventory of supplies is desired.
- Experience in the creation and revision of Standard Operating Procedures (SOPs) is desired.
- This position requires training in blood borne pathogen safety measures. New hires will be given the option of Hepatitis B vaccination.
- This Position requires use of cryogenic substances (liquid Nitrogen). Training in the use of liquid nitrogen is required.