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Manufacturing Associate (Media Preparation, Aseptic)

Location
Summit, New Jersey
Job Type
Permanent
Posted
1 Oct 2021
Job DescriptionTITLE: Manufacturing Associate (Media Preparation)06 months (Contract to Hire)Summit, NJWednesday (Week 1 Sunday through Wednesday, Week 2 Sunday through Tuesday) JOB DESCRIPTION:1. Purpose and Scope of Position - Contract/Temp to Hire Position:Manufacture of cell culture media and buffers in support of S12 liso-cel CAR T manufacturing per Standard Operating Procedures (SOPs) and cGMP batch records in a controlled, cleanroom environment.2. Required Competencies: Knowledge/ Skills, and Abilities:- Understanding of media and buffer preparation requirements for cell culture.- Proficient in aseptic processing and lab techniques.- Familiarity with cGMP/FDA regulated industry- Attention to detail will be critical to maintaining quality standards with emphasis on Right the First Time.- Basic mathematical skills- Ability to read, execute and document steps in a GMP batch record- Proficient in MS Office applications- Background to include a basic understanding of biology, chemistry, or pharmaceutical processing3. Duties and Responsibilities:- Manufacturing of cell culture media and buffer solutions in a controlled cleanroom environment Maintain up to date records for training on controlled, approved GMP procedures for Media and Buffer preparation to support CAR T manufacturing.- Assist with Lab Support activities: Coordinate with Warehouse Operations to move materials into the process suites and serve as a runner when needed.- Participate in shift exchanges of information to ensure seamless operations- Other duties may be assigned, as necessary.4. Education and Experience:Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experienceOR High School diploma/GED and 3 years of Manufacturing or Operations experience.Experience working in a Biological Safety Cabinet using aseptic technique.Qualifications5. Working Conditions:- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.- Physical dexterity sufficient to use computers and documentation.- Sufficient vision and hearing capability to work in job environment.- Ability to lift up to 25 pounds.- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and arms/legs/feet.- Makeup, gum, nail polish, jewelry or other potential microbial sources are prohibited in controlled areas.- Controlled areas will prohibit food, drink or any outside materials such as cell phones or tablets, at a minimum.- Flexibility to don clean room garments and personal protective equipment (PPE).- Clean room environment is an enclosed, restricted space, with controlled air pressure and temperature conditions.- Use of reagents, chemicals, and exposure to sanitization agents are expected.- Ability to work in the vicinity of strong magnets.- Potential routine exposure to human blood components is possible.Additional InformationAll your information will be kept confidential according to EEO guidelines.Job Location
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Details

  • Job Reference: 386584257-2
  • Date Posted: 1 October 2021
  • Recruiter: Infotree Service Inc
  • Location: Summit, New Jersey
  • Salary: On Application
  • Sector: Advert / Media / Entertainment
  • Job Type: Permanent