Biomanufacturing Specialist

4 days ago


Reston, Virginia, United States Kelly Science, Engineering, Technology & Telecom Full time

Manufacturing Specialist (Contract 6 months)

Location: Winston Salem, NC

Hourly Pay Rate: $20-$25 DOE

Job Type: Contract

Shifts: Sunday-Tuesday 6am-7pm and Wednesday 7am-2pm

Thursday-Saturday 6am-7pm and Wednesday 11am-6pm

Kelly Science is seeking a skilled Manufacturing Specialist to work with a cutting-edge technology-based client within the biotechnology space.

Responsibilities:

  • Participate in the aseptic processing of solutions in compliance with current Good Manufacturing Practices (cGMPs).
  • Prepare cleaning solutions for sanitizing cleanrooms according to established procedures.
  • Condition and prepare biopsy and product shipping containers, ensuring accurate documentation.
  • Maintain and stock the cleanroom environment to ensure it remains within alert level limits by following established procedures.
  • Set up and operate production equipment, such as control rate freezers and orbital shakers.
  • Assist in daily manufacturing support activities, including vial retrieval, quality control (QC) sample submission, and freezing of process cells.
  • Manage the cleaning and maintenance of GMP suites and surrounding areas, including routine gowning rooms, biological safety cabinets (BSCs), and other cleanroom facilities.
  • Complete GMP documentation, including batch records, logbooks, and forms, in accordance with Good Documentation Practices (GDP).
  • Adhere to all safety policies, rules, and regulations.
  • Perform procedures according to written guidelines and identify deviations from accepted practices.
  • Monitor temperatures, material expiration dates, and the calibration of equipment.

Requirements:

  • AS/BS in Biotechnology, Biology, Chemistry, or a related field is preferred.
  • High School Diploma or equivalent may be considered with relevant experience.
  • 1 year minimum cGMP industry experience in biopharmaceutical space


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