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Biopharma Manufacturing Associate

LanceSoft Inc, Rockville MD

  

Description:

  • Under the direction of      senior personnel, performs production operations including fermentation or      cell culture operations, preparation of media and buffer solutions,      chromatographic separation, filtration and concentration operation, etc.      as well as being involved in both start-up and product changeover      activities
  • Including Completing      daily manufacturing tasks per standard operating procedures and batch      document instructions
  • Monitors critical      process parameters Documenting all manufacturing activities clearly and      accurately
  • Ensures all processing      equipment and materials necessary are adequate and available to set the      team up for success
  • Ensures all production      activities are completed in a safe and compliant manor. Maintain and      prepare high quality documentation
  • Dispense large and small      amounts of raw materials Perform CIP and SIP of product tanks Work with      hazardous materials under the appropriate safety procedures Performs other      functions as necessary or as assigned. Maintain at least an 95% cGMP training      proficiency to ensure compliance 

Skills Required: 

  • Minimum Level of      Education - BS/BA or Associates Degree with 0-2 or more years of directly      related experience. Degree in other discipline (or lack of degree) may be      considered if enough technical depth has been achieved from professional      experience
  • 0-2 years prior      manufacturing experience in the pharmaceutical or biotechnology industry,      with the demonstration of a high level of performance Understanding of the      basic FDA cGMP regulations Strong verbal and written skills
  • Must be able to follow      detailed processing instructions as well as accurately documenting all      necessary documentation. Ability to work shift that covers a 24/7      operation Ability to lift and carry materials weighing as much as 50lbs.
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