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!
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
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