Production Associate II (Weekends)

Ossium Health

Indianapolis, IN, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 01/20/2021
  • Website: ossiumhealth.com
  • Company Address: 25 Taylor Street, San Francisco, CA, 94102

About Ossium Health

Ossium is building the world's first bone marrow bank to treat blood cancers, improve organ transplantation, and repair damage from radiation.

Job Description

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 technical support and execution of tasks within Ossium Health’s Production group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use.  An Associate II must have an intermediate understanding of the theory, concepts and regulations behind cGMP cell production.  Tasks require judgment in resolving problems and making routine recommendations.  An Associate II must demonstrate understanding of production systems with a consideration of process impact of other areas; and understanding of both the theoretical and practical aspects of aseptic technique, cell culture and cleanroom workflow. Tasks require following standard operating procedures (SOPs) and working in an ISO7 cleanroom environment. 

Responsibilities

    • Perform production tasks as operator or verifier in the production of bone marrow derived products;
    • Perform manual aseptic processing (must be proficient and fully trained in clean room gowning and aseptic technique). Must consistently demonstrate proficient aseptic technique;
    • Maintain cryogenic freezers and product inventory using an electronic inventory system;
    • Author or assist in drafting and revising of departmental procedures;
    • Assist in shipping of frozen samples and product from bank;
    • Prepare supply kits for each production process;
    • Assist in cleaning and autoclaving of tool kits;
    • Participate in tech transfer activities related to new or enhanced processes in the production facility;
    • Stock production and gowning areas as required;
    • Perform routine and advanced duties required to clean, maintain and operate production equipment;
    • Perform activities in accordance with current Good Practices (cGXPs);
    • Consistently strive to grow understanding of key theoretical and practical aspects of cellular production and testing concepts and relevant regulations;
    • 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;
    • Work with coworkers and supervisor to effectively troubleshoot equipment and process issues; assist with investigations into root cause analysis;
    • Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner;
    • 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;
    • 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 Supervisor;
    • Interact with QC department to submit sample requests and prepare reports;
    • Interact with Supervisor to provide updates, results, suggestions, and work area/process observations;
    • Interact with vendors to provide equipment, components and best practices to the process;
    • Assist in training of new staff as directed by Supervisor;
    • Other responsibilities as qualified and assigned/agreed to

Qualifications

    • A BS or BA in biological sciences or equivalent is preferred, however exceptions may be made based on relevant industry experience.
    • 1+ years of experience working in a cleanroom environment, cell therapy, tissue banking, blood banking or a closely-related industry required.
    • Must possess scientific aptitude and be able to document all work clearly and thoroughly on records.
    • High level of attention to detail in both operations and documentation is a must. 
    • 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 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
    • 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 
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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.