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Manufacturing Associate

Manufacturing Associate Job description pdf

Reports to: Sr. Manufacturing Scientist, Cell Therapy Technical Operations
Location: Houston, TX
Inquiries and Resumes should be sent to: careers@ziopharm.com

About Ziopharm
Ziopharm is developing commercially scalable, cost-effective T-cell receptor (TCR) T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform targeting solid tumors. The company has clinical and strategic collaborations with the National Cancer Institute and The University of Texas MD Anderson Cancer Center. For more information, please visit www.ziopharm.com. Ziopharm is a public company (NASDAQ: ZIOP).

Summary

The Manufacturing Associate, Cell Therapy Technical Operations, is primarily responsible for hands on manufacturing of cell therapy products under cGMP guidelines and supporting cellular therapeutic manufacturing operations for Ziopharm’s in-house manufacturing campaigns. Secondary responsibilities will include assisting in process transfers, technology improvements, generation of batch records, process validation and related materials, documents, and reports associated with Ziopharm’s clinical trials and manufacturing of clinical product with high quality and timely output. This position is the technical and operational support for the Cell Therapy Technical Operations pipeline.

Responsibilities

  • Work in a clean room environment according to cGMP regulations
  • Operate bioprocess equipment for Cell Culture Operations
  • Prepare Buffer and Media solutions
  • Execute batch records and organize documentation associated with clinical manufacturing and development activities
  • Assist with technology transfers between laboratories and GMP facility
  • Review process and batch record documentation including, but not limited to, peer review
  • Assist with preparing data analysis and trending for process, stability and analytics
  • Support development of BPRs, SOP’s, WI’s, and associated documents for manufacturing processes
  • Assist with raw material supply management activities
  • Work with Process Development to optimize and characterize processes for manufacturing
  • Perform laboratory activities related to clinical manufacturing

Qualifications

  • BS in science related area or engineering, and a minimum of 1-3 years in the biotechnology industry
  • Experience in manufacturing environment or other regulated industry required
  • Experience in cGMP biologics cell culture manufacturing and cell therapy fields preferred
  • Self-motivated individual with the ability to work independently and as a member of cross-functional teams in a dynamic and highly collaborative environment
  • Solid technical, written, and verbal communication skills
  • Must be able to perform error-free mathematical calculations
  • Proficient in Microsoft Office
  • Attention to detail
  • Must have ability to work assigned shift (day, night, holidays, and weekends)
  • Must be comfortable with being fully gowned in PPE and working in a clean room environment, which is an enclosed, restricted space with an assigned pressure and temperature conditions.
  • Must be comfortable with being exposed to human blood components
  • Must be able to work near proximity to strong magnets

Preferred

  • Established knowledge of universal precautions for handling human derived materials in BSL-2 containment areas
  • Established knowledge of manufacturing workflows
  • Established knowledge of aseptic techniques and gowning procedures
  • Experience in cell separation techniques and automated equipment would be an asset
  • Experience in cell washing processes and automated equipment
  • Experience in cryopreservation processes, materials, and equipment