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Cell Manufacturing Associate II

JOB OVERVIEW:
The purpose of this position is to work as an integral part of the laboratory manufacturing team. The responsibilities of this position constitute the manufacture of adult mesenchymal stem cell products for banking and for therapeutic use.

JOB DUTIES:

• Perform hands-on aseptic cell culture
• Perform specialized manufacturing steps for cell culture, such as cell isolation, thawing, cryopreservation, sub-culturing, and harvesting following approved standard operating procedures (SOPs)
• Follow only Manager approved instructions when an SOP is called into question per individual circumstance
• Demonstrate proficiency with manufacturing procedures and responsibilities
• At all times maintain cGMP guidelines
• Demonstrate proficiency in good documentation practices
• Maintain accurate and timely manufacturing records, paper and electronic notebooks and records
• Document and write clearly and legibly
• Document and maintain LUMACs on assigned equipment
• At all times, effectively use and maintain proper aseptic technique
• Maintain the cleanliness of the laboratory clean room, equipment, and storage tank areas through routine cleaning and sanitization, as well as through proactive behavior
• Examine and evaluate data related to problems and propose corrective solutions
• Attend and participate in group and project meetings
• Recommend changes to any process or task to increase efficiency, increase cell yields, and decrease costs
• Participate in other duties, as assigned
• Exhibit responsibility and ownership for your actions
• Contribute to the laboratory culture and team environment at all times
• Participate in validation and research projects, as assigned
• Train new associates and maintain training file for review
• Participate in writing and revising SOPs
• Conduct group training for manufacturing, as assigned
• Maintain required material inventory levels for manufacturing and manufacturing process development
• Under manager’s guidance, defines and successfully executes new continuous improvement initiatives

EDUCATION/EXPERIENCE AND SKILL REQUIREMENTS:

• Master’s degree in biology, microbiology or other relevant life science field; or bachelor’s degree in a related field and at least two years of experience in cGMP
• Excellent quantitative mathematical skills
• Exemplary, focused and unbiased attention to detail
• Excellent communication and interpersonal skills
• Ability to work in a fast-paced environment
• Experience in mammalian cell culture preferred
• Ability to creatively manage time and elevate relevant issues to Manufacturing Manager
• Self-motivated and willing to accept temporary responsibilities outside of initial job description

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Must be able to work around bio-hazardous materials (Ex., human adipose tissue) and chemicals (Ex., disinfectant and sporicidal agents
• Must be able to lift up to 30 lbs.
• Must be able to push liquid nitrogen tanks
• Must be able to work in a cleanroom environment with full personal protective equipment
• Must be willing to work on pre-assigned weekends and holidays

REPORTS TO: Manufacturing Manager

DEPARTMENT: Operations – Manufacturing

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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.