Upstream Manufacturing Associate
Latitude, Inc. Baltimore, MD
- Posted: over a month ago
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
Powered by JazzHR
ManufacturingView all jobs at Latitude, Inc.