Manufacturing Associate I, CTMF Facility

The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

The Manafacturing Associate I of the Cell Therapy Manufacturing Facility will be responsible for performing the various taks in/or each of the following areas: Cell Therapy processing, Viral Vector processing, or Tissue culture. Duties will include cleaning, kitting, documentation, processing, and material procurement. The candidate must be willing to work a flexible schedule as business needs dictate. Weekend work or off-shift shceduling may be required.

KEY FUNCTIONS

• Able to understand and follow personnel flows, cleaning procedures, gowning requirements and other procedures defining requirements necessary to ensure cGMP compliant operations of cleanroom facilities.
• Assist with training staff on proper operations and documentation in cGMP cleanroom facilities.
• Able to perform or assist in deviation writing, CAPAs, Root Cause Analysis, or Change Controls. Technical writing skills are required.
• Experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges.
• Some experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Incubators, Cell Stacks, Cobes, or Lovos.
• Provide input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment
• Coordinates with various departments, such as QA, QC, Material Management, Process Development, and Project Management when required to ensure deadlines are met.
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
• Meticulous attention to detail in terms of documentation, following procedular SOPs, and performing functions as it pertains to the Batch Record.
• Able to develop new SOPs for new and incoming equipment.
• Assist support for routine maintenance acitivites.
• Ensure transparent communication with staff, teams, support functions, and site leadership team.
• Establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and Biologics Development goals.
• Other duties as assigned.

Education

Required: High school diploma or equivalent.

Preferred: Bachelor's degree.

Experience

Required: Two years or relevant experience. With preferred degree, no experience required.

Preferred:

Must be proficient with Microsoft Office: Word, Excel, and PowerPoint.
Extensive hands-on Cell and Tissue Culture experience.
Extensive hands-on cGMP experience.
Excellent interpersonal, verbal and written communication skills.
Willingness to think outside of the box, ability to adapt in a constantly evolving environment.
Ability to lift 40 lbs repeatedly and stand for hours at time.
Able to work off shift hours and weekends, as schedule dictates.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html