At Agensys, we're changing tomorrow by moving oncology
forward. We’ve developed a pipeline of novel therapeutic fully
human monoclonal antibodies (MAbs) to treat solid tumors based on
our own proprietary targets. We have discovered and validated a portfolio
of clinically relevant targets in 14 different cancer types. Our pipeline
includes therapeutic MAbs to multiple cancer indications that are
at different stages of clinical and pre-clinical development.
The Manufacturing Associate IV, Downstream Lead's
essential tasks are as follows, but not limited to:
1. Perform a variety of clinical manufacturing activities, including
operation of Chromatography skids, column packing, clarification,
and related purification steps.
2. Accurately record process documentation
3. Troubleshoot process equipment or issues as needed
4. Develop, review or revise process documents and SOP (Standard Operating
Procedures) to support the MFG operations
5. Comply with current Good Manufacturing Practices (cGMP), safety
regulations, SOPs, and Batch Production Records
6. Assist with validation protocols, IO/OQ/PQ, as needed
7. Assist with observations or deviation investigations as needed
8. Experience with Chromatography skids, Ultrafiltration / diafiltration,
and Filling operations
Additional Lead responsibilities are as follows,
but not limited to:
1. Lead investigation teams
2. Review Batch Production Records
3. Organize daily work tasks with Associates working in the Downstream
area (includes Purification and Buffer Preparation)
4. Interact with Upstream lead regarding process, coverage and the
like
5. Interact with the Inventory Management representatives regarding
additional, new or changes to supplies
6. Interact with QC Micro and QC Analytical regarding process samples,
process delays or test results
7. Provide MFG Manager real-time notification of process deviations
or possible issues with production runs
Job Requirements
A Bachelor’s degree in Life Science or related field
A minimum of five year experience in Manufacturing, Purification Clinical
or Commercial experience preferred
Demonstrate leadership skills and is a team player
Ability to troubleshoot / investigate mechanical issues and process
observations
Excellent documentation skills and knowledge of GMP requirements
