Cell Therapy Associate, Clinical Manufacturing
Ossium Health
Indianapolis, IN, USA
Posted on Wednesday, September 13, 2023
Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood and immune diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
We’re looking for a Cell Therapy Associate to join our growing manufacturing team. This position provides technical support and supports execution of tasks within Ossium Health’s Clinical Manufacturing group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use. Tasks require following standard operating procedures (SOPs), producing bone marrow derived cell therapy products, and mesenchymal stem cell (MSC) culture in an ISO7 cleanroom environment. Position requires basic judgment in resolving problems and making routine recommendations to management to improve workflow. This is a great opportunity for someone with cell-focused lab experience who is looking to further a career in bioengineering by joining a fast-growing biotech company.
Required Qualifications
- BS or BA in biological sciences
- Experience in cell therapy, cell culture, tissue banking, blood banking or a closely-related industry
- Scientific aptitude and ability to clearly and thoroughly document all work on existing forms and records
- High level of attention to detail in both operations and documentation
- Excellent written and oral communication skills
- Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
- This position is based full time in our Indianapolis facility
Preferred Qualifications
- Mesenchymal stem cell culture experience
- Understanding of the theory, concepts and regulations behind cGMP cell manufacturing (cGMP cleanroom experience, cGMP SOP writing, or GLP laboratory experience)
Key Responsibilities
- Perform manufacturing tasks in a cleanroom as operator or verifier in the manufacturing of bone marrow derived products (with emphasis on MSCs)
- Perform manual aseptic processing (must be proficient and fully trained in cleanroom gowning and aseptic technique)
- Maintain cryogenic freezers and product inventory using paper and electronic inventory system
- Assist in shipping and logistics of samples and product from bank
- Assist team in maintaining cleanrooms, including but not limited to routine and non-routine cleaning, environmental monitoring of cleanrooms, and continuous monitoring of equipment
- Author or assist in drafting and revising of departmental procedures
Physical Requirements
- Must be able to work aseptically in controlled environments requiring special gowning (i.e. over the head, face, hands, feet and body)
- Must be able to work in a moderately noisy environment
- Must be able to work around biohazardous materials and chemicals
- Must be able to lift, push, pull and/or carry up to 25 pounds
- Must be able to use hands and fingers to handle and feel objects, tools, and controls
- Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, stoop, crouch; use hands to handle or feel; and reach with arms.
Schedule
- Full-time (40 hours per week)
- This is an hourly, non-exempt role that is eligible for overtime
- Occasional weekend/evening work required
Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.