Operation of upstream or downstream processing equipment according to established SOPs. This equipment includes but is not limited to bioreactors, TFF skids, biological safety cabinets, incubators, chromatography skids, UFDF skids, and product hold tanks.
* Upstream or downstream processing according to established manufacturing production records (MPRs) in accordance with cGMPs
*Demonstrated ability to perform all process steps of upstream or downstream production operations
* Ability to generate SOPs, MPRs, and SPRs for equipment and procedures used in the manufacture of biological based products
* Execution of validation protocols as required
* Execute projects with minimal instruction and management oversight.
* Assigning daily tasks to production technicians pertaining to manufacture of biological based products
* Complete manufacturing documentation per approved procedures Includes reviewing documentation for completeness and accuracy per established timelines
* Act as qualified trainer for process equipment
* In-direct supervision of production technicians.
* Provides input into annual performance evaluations of production technicians as applicable.
* Investigate and resolve problems. Clear and concise communication to Supervision/Management
* Coordination of production tasks to meet assigned schedule
* Other duties as assigned or identified