Position Summary: This Senior 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 use. This work will involve executing and documenting the established methods as well as methods in development. It will also involve the implementation of new methods and comprehensive technical oversight of manufacturing facilities.
- Responsible for qualifying and training clinical and non-clinical site cell processing laboratories in the preparation of bone marrow derived-derived cell therapy products.
- Responsible for the supply chain and inventory of kits used for product preparation at clinical sites.
- Responsible for training organ procurement organization technical staff in procurement and shipping source tissues.
- Responsible for training and/or 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.
- Write and review 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 4-7 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.
- The candidate must be prepared to travel as much as xx% of the time.
- 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.