Principal Manufacturing Associate

FLSA Classification: Exempt/Salary 

Schedule: Monday-Friday; 1230-2100 (12:30 PM- 9:00 PM) 

Department: CMC- GMP 

Reports to: Associate Manufacturing Manager  

Supervisory responsibilities: No 

Location:  

1) Weatherford Building: 13203 Murphy Rd., Stafford, TX 77477   

2) UTH GMP Facility: 1941 East Rd., Houston, TX 77054  

GxP Position: Yes 

Position Summary/objective: 

The primary purpose of this position is to oversee daily GMP activities and act as a “man-in-plant” or SME for all IMA20x manufacturing processes and activities.  

Essential functions: 

• Knowledge of current cGMP. 

• Provide instruction to facilitate workflow, shift activities, and shift exchange ensuring all activities are completed as assigned. 

• Provide a safe and controlled work environment.  

• Responsible for investigating and troubleshooting deviations and unexpected events and is the person of contact for deviation initiation and completion.   

• Maintains competency status to serve as backup for manufacturing associates for daily manufacturing processes.  

• Serves as backup for reviewing executed batch records and documents. 

• Responsible for coordinating with the Training Department to include training needs on the manufacturing schedule. 

• Collaborates with the MSAT/PD teams to transfer new projects into GMP. 

• Works cross-functionally and in collaboration with internal groups to develop or update internal policies, procedures or steps, identifies and escalate risks, communicates changes and plan for execution. 

• Leads routine team meetings. 

• Ability to work productively and to participate in a highly creative and fast-paced environment. 

• Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.  

• Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs. 

Secondary functions: 

• Assign and schedule all manufacturing activities.  

• Performs preliminary review of completed BRs and worksheets prior to CMC and QA review. 

• Determines required corrective actions resulting from deviations or CAPAs and develops implementation plans. Acts as CAPA lead when required.  

• Reviews and ensures completion of all manufacturing related logs.  

• Leads implementation of new equipment including but not limited to execution of IQ/OQ/PQ, associated SOP, and maintenance documentation.