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About Ossium:
Ossium Health deploys cellular therapeutics, bioengineering, and other regenerative medical tools to drive lasting gains in the health, vitality and longevity of human beings. We develop, process, 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.
Position Summary: This position provides support and execution of tasks within Ossium Healths Production group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use.
Responsibilities:
- Perform production tasks as operator or verifier in the production of bone marrow derived products;
- Perform routine duties required to clean, maintain and operate production equipment and facilities;
- Assist in cleaning and autoclaving of processing tools and laboratory supplies;
- Stock production and gowning areas as required;
- Prepare media and reagents as required;
- Assist in maintaining inventory system for bone marrow derived products and supplies;
- Perform activities in accordance with current Good Practices (cGXPs);
- Perform manual aseptic processing (must be proficient and fully trained in clean room gowning and aseptic technique). Must consistently demonstrate proficient aseptic technique;
- Understanding of production system with a consideration of process impact of other areas;
- Understanding of both the theoretical and practical aspects of aseptic technique and cleanroom workflow;
- Consistently demonstrate good documentation practices;
- Adhere to company and departmental training requirements; Document and maintain training records for read and understand and on the job training;
- Adhere to company documentation and verification guidelines as they apply to all processing documents; e.g., batch production records, SOP's, equipment, log sheets;
- Assist in drafting and revising of departmental procedures;
- Work with coworkers and supervisor to effectively troubleshoot equipment and process issues; assist with investigations into root cause analysis;
- Recognize and communicates production and work environment issues/observations to supervisory staff in a timely manner;
- Adhere to all standard operating procedures (SOPs);
- Participate in departmental quality initiatives: Adhere to Safety, Quality, and all other applicable company, site and departmental procedures, policies, practices and goals;
- Actively participate in safety vigilance and safety improvement programs;
- Assist in maintaining the production areas and records in an inspection ready state at all times;
- Communicate effectively and professionally with all staff;
- Execute and/or support process development experiments as requested by the CSO or Director of R&D;
- Interact with QC department to submit sample requests;
- Interact with Supervisor to provide updates, results, suggestions, and work area/process observations;
Qualifications:
A BS or BA in biological sciences or equivalent is required, however exceptions may be made based on relevant industry experience. Experience in cell therapy, tissue banking, blood banking or a closely-related industry preferred. Must possess scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records. High level of attention to detail in both operations and documentation is a must.
Supervisory
Responsibilities:
This person has no direct supervisor responsibilities.
Working Environment
- 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 bio-hazardous materials and chemicals
Physical Requirements/Demands
- Requires training in blood borne pathogen safety measures. New hires will be given the option of Hepatitis B vaccination.
- Requires use of cryogenic substances (liquid Nitrogen). Training in the use of liquid nitrogen is required.
- 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.
- Must be able to successfully pass routine gowning and aseptic qualifications.
- Must be able to work in aseptic areas and in compliance with 21 C.F.R. 211.28, a copy of which is attached.
21CFR §211.28 Personnel responsibilities.
(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
(b) Personnel shall practice good sanitation and health habits.
(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.
(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
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