What are the responsibilities and job description for the Clinical Production Operator I position at Ossium Health?
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, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
This position provides technical support and execution of tasks within Ossium Health's Clinical Production group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use. Tasks require following standard operating procedures (SOPs) to process human tissue in an ISO7 cleanroom environment for Ossium's bone marrow and tissue products. Position requires basic judgment in resolving problems, effective communication with coworkers and management, and close attention to detail.
Required Qualifications
- High school diploma
- Excellent written and oral communication skills
- Capability to operate with a high level of organization and time management in a dynamic startup environment
- High level of attention to detail in checking work and information for accuracy and quality
- Reliable and able to produce consistent, high quality work
- Great work ethic, positive attitude, and ability to work as part of a team
Preferred Qualifications
- Hands on laboratory experience working in a biological safety cabinet, pipetting, preparing reagents, and using lab equipment
- Experience working in a cleanroom environment, research laboratory, cell therapy, tissue banking, blood banking, or a closely-related industry
Key Responsibilities
- Perform production tasks in accordance with GMPs as operator or verifier in the production of tissue and/or bone marrow products in an ISO7 cleanroom environment. Tasks include tissue receipt, tissue processing, and cell processing utilizing some automated equipment while completing documentation in real time
- Maintain cleanrooms and production suite, including but not limited to routine and non-routine cleaning of biological safety cabinets, cleanrooms and equipment, environmental monitoring of cleanrooms, and continuous monitoring of equipment
- Maintain cryogenic freezers and product inventory using an electronic inventory system
- Collaborate with coworkers and supervisor to effectively troubleshoot equipment and process issues using critical thinking skills
- Participate in development and tech transfer activities related to new or enhanced processes in the production facility
Physical Requirements
- Must be able to work aseptically in controlled environments requiring special gowning (ie. 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 lbs
- 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, climb, stoop, kneel, 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
- Monday - Friday,
- Shift 1: 6am start or
- Shift 2: flex start 8am or 10am (depending on day)
- Some holiday work required
- Must be available for training as early as 8am
We offer a full slate of employee benefits including:
- Competitive salaries
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Four weeks of PTO accrued (vacation & sick time) annually 11 company holidays
- Employer paid life insurance and long term disability
- Gym membership/recreational sports reimbursements