Senior Manufacturing Associate (2nd Shift)

FLSA Classification: Exempt/ Salary 

Schedule: Monday – Friday; 12:30pm – 21:00pm: Weekends and Holidays as needed 

Department: CMC - GMP 

Reports to: Associate Manufacturing Manager 

Supervisory responsibilities: No 

Location:

• Weatherford: 13203 Murphy Rd. Stafford, TX 77477 ;  

• UTHealth Science Center: 1941 East Rd, BBSB 6102 Houston, TX 77054 

Position Summary/objective: 

The primary purpose of this position is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing. 

Essential functions: 

• Knowledge of current cGMP. 

• Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash. 

• 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. 

• Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions. 

• Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers. 

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

Secondary functions: 

• Independently perform calculations to determine cell viability, dilutions, and cell concentrations.   

• Completes all appropriate logs and trackers. 

• Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility. 

• Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria. 

• Conducts activities to support study plans, and IQ/OQ/PQs. 

• Reviews and provides assistance with change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed. 

• Provides improvement and troubleshooting ideas, and executes implementation plans.  

• Performs routine equipment maintenance and troubleshooting. 

• Prepares high level overviews and leads presentations, as needed. 

Competencies