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Production Associate II

Employer
CoImmune, Inc.
Location
Durham, NC
Start date
Jan 29, 2021

Scope: The individual will conduct cGMP manufacturing of a cell-based product. This includes validation and development runs under cGMP and assistance in technology transfer of novel products. All activities will be performed in a cGMP-compliant environment.

Responsibilities:

  • Execute procedures to manufacture cell therapy products ensuring that production batch records are completed at the highest standards according to Company policies and procedures.
  • Assist with review and organization of completed batch records, address deviations and support investigations as necessary.
  • Perform daily clean room activities such as equipment/material preparation and cleaning/sanitization of equipment and rooms including packaging and disposing of biohazard waste per established procedures.
  • Assist in ordering and transfer of materials and maintain supplies adequate for production demands. Stocking of non lot controlled materials and cleanroom garments.
  • Assist with execution of environmental monitoring of air, surfaces and personnel in classified areas.
  • Provide assistance with authoring and revision of Batch records, SOPs, Temporary changes, Item Specifications and other cGMP documentation.
  • Collaborate with and assist other groups with projects by executing protocols associated with validation, technology transfer, etc.
  • Perform other duties as required.

Qualifications:

  • Requires Associate Degree with 0-2 years’ experience. May have a Bachelors degree; however not required.
  • Experience with cell culture and/or molecular biology and aseptic techniques is strongly preferred.
  • Good communication skills to clearly convey complex information and ensure proactive communication in timely manner.
  • Must have strong computer skills.
  • Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other groups.
  • Must have initiative, high attention to detail, and the ability to multi-task
  • Flexibility with work schedules and duties including necessary extended hours, weekends and holidays.
  • Ability and willingness to be regularly, predictably, and reliably at work.

Physical Demands: Majority of work is sedentary with sitting, standing and bending. Some occasional physical demands such as: pushing, pulling, and lifting up to 30 lbs. Good dexterity and balance required. Work will require working with Biohazardous, small quantities of chemical materials, as well as ultra-cold temperatures while wearing personal protective equipment.

EOE

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