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Latitude, Inc. Upstream Manufacturing Associate in Baltimore, Maryland

We are seeking entry level to lead level upstream manufacturing associates.

The upstream manufacturing associate role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

  • Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps

  • Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs

  • Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment

  • Recommend equipment and other supply purchases within the production areas

  • Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays

  • Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns

  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

The Candidate

  • HS or GED with 2+ years? experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate degree in a Scientific, Engineering or Biotech field with 2-4 years? experience with upstream or downstream biologic production processes under GMP compliance OR Bachelor?s degree in a Scientific, Engineering or Biotech field with 1-3 years? experience with upstream or downstream biologic production processes under GMP compliance

  • Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks

  • Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP?s, deviation & summary reports

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